Scott Benner 6/24/23 Scott Benner 6/24/23

#935 Weight Loss Diary: Three

Scott is taking Wegovy for weight loss. This is diary number three.

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DISCLAIMER: This text is the output of AI based transcribing from an audio recording. Although the transcription is largely accurate, in some cases it is incomplete or inaccurate due to inaudible passages or transcription errors and should not be treated as an authoritative record. Nothing that you read here constitutes advice medical or otherwise. Always consult with a healthcare professional before making changes to a healthcare plan.

Scott Benner 0:00
Hello friends and welcome to episode 935 of the Juicebox Podcast

if you've been following my week Ovi diary This is entry number three entry one was just like this entry is going to be every week that I injected I came on and talked a little bit about the previous week did the injection moved on? We go read diary number two was actually me talking to Erica Forsythe about the metaphorical empty feeling I had while on we go V and today we're back to the injection conversations. So while you're listening, please remember that nothing you hear on the Juicebox Podcast should be considered advice, medical or otherwise, always consult a physician before making any changes to your health care plan. If you're looking to save some money, here three quick ways betterhelp.com forward slash juice box saves you 10% On your first month of therapy, athletic greens.com forward slash juice box get you five free travel packs and a year's supply of vitamin D with your first purchase of ag one from athletic greens. That's a green drink that was so many people talk about. I drink it every day. And the offer code juice box at checkout will save you 35% At cosy earth.com This episode of The Juicebox Podcast is sponsored by me, Scott. I'm just here to remind you that if you're listening to this podcast, and you're not using an audio app or a podcast app like Apple podcasts, Spotify, Amazon music, so on and so forth. Please consider getting one on your phone, downloading the podcast, subscribing and following. It's absolutely free. And it's the best way to listen. I want to remind you too, that there is a Facebook group for the podcast 40,000 active users, and it's just amazing. Juicebox Podcast type one diabetes, even though that's the name I don't care what kind of diabetes you have. We welcome you doesn't matter how you eat, how you live, how you think how you feel. You got diabetes, you love someone with diabetes, you're welcome in the group Juicebox Podcast type one diabetes

Hey, everybody, good morning. It is May 9 Tuesday, time for my 123 my seventh injection of we go V still on the point five milligrams. dose the last week. Last week, I had not a lot of weight loss. And then a little bit over the weekend to 220 pounds 220 pounds where I'm at now. And I basically stayed at that weight all week to 20 in the morning to 20.2 next day to 20 next day to 20.4 this morning to 20. So how was my eating this week? Not bad. I increase the amount of food I took in. I added I had some bread this week, which I didn't do the week before. And I added more red meat and I didn't lose any weight. It didn't gain any weight. I mean, I lost a couple pounds but I mean there was no like big weight loss. But my weight is incredibly stable. I feel great. I don't have any problems. Little bit of reflux if I eat the wrong thing. Who What did that mean? Okay, two things. I was at an event where I spoke and I had a little cheese cake. I think I might have brought that up and the other one that didn't sit well. But this week, what I really had to focus on was not eating late at night and late at night man after 658 after six I'd have kind of like a reflux feeling. So that's it. All right, this is a let's see. Number seven. Alright, so here comes injection number seven. Sticking with the belly working well so far

all right, I'll see you next week. Hello everybody. I am back to do my eighth injection of weego V. This is the last point five milligram injection I move up to the one milligram next week. I lost Three pounds this week I'm to 17.2 this morning, and BMI continues to drop slowly. Body fat dropped pretty significantly over this week down to 31.4 from like 3332 My body water keeps increasing, which is good. And let's see what else is here. I am going to tell you what scale this is because I'm liking this skill. Fat free body weight is dropping down to 140 9.2 subcutaneous fat dropped from 28.7 to 27.1 this week, visceral fat down another point from 16 to 15. Let's see what else I got here. I don't know how it says protein but that's going up metal and my metabolic age went down to 57 I'm almost to my actual age Amy What is this thing called it is the

bread fo r e n p H O is the scale. My wife said it was like 40 bucks or something like that on the on the Amazon. Alright, so I'm going to do another injection in my stomach. And what was this week like? Still eating late at night will lead to like reflux. So I mean I'm down to like I try not to eat after like 6pm at this point. If I do certain things are okay, like I eat a I'm a small gram cracker the other day and it was like Kodiak. So it was all like protein thicker. First of all, it didn't taste great. But secondly, it just sat really heavy on my stomach. But I had like a rice cracker the next night, and that didn't bother me. So I think the density of the food later at night has something to do with it. My hunger is exactly the same. I don't really think about food. I have to remind myself to eat I eat on a schedule. Or you know, where I just won't think to eat. I'm not hydrating enough. I wish I was drinking more. I'm going to try to push myself to drink more all my supplements I have no trouble with vitamin D, zinc, digestive enzyme, things like that all are going in no trouble. Sit on my stomach very well. I injected like you heard in the previous recording, I was a little like steady my weight was kind of steady last week. But I injected the week over on Tuesday I woke up the next day like 1.2 pounds lighter. i Right now weigh this is the lowest I've weighed since 2018. So in five years, I would not say that my lifestyle. I mean, I guess if you want to make eating food, like part of your life, like meaning, like it's super important to you, like obviously, I haven't had pizza or anything like that in the last couple of months. But I would say my lifestyle hasn't changed at all, I've just adapted a little bit. I feel so much better. Having lost this wait. I'm super excited to see how I'm gonna feel, you know, 15 more pounds from now hopefully. So let's get this done. And then I'll let you get back to your lives. Here we go. I'm gonna just move the microphone towards my injection spot. Take off the cap. And here we go V

it's in baby. I'll be back next week with the one unit injection or the one milligram injection. I keep saying units because the diabetes you know that right? Say, Hey, it is May 23. And I am back to talk about my first one milligram injection of we go up before I do. Let me just open up the app that came with the scale, which is working very well I think and tell you that I have Yep. Took my weight the first time on 328 Bytes march right March 28. Today is May 23. And I have lost exactly I mean Exactly. To the ounce. 20 pounds. Crazy. So last week, like as you heard just a second ago. Not a lot happened. This week. I just you know stayed the course actually went to a graduation party had like a reasonable amount of food continued to lose weight this week added some exercise this week for the first time in the form of household chores. So I had a big project that I wanted to do outside was going to be many hours, probably by the time I got done 2025 hours of moving over three days, outside physical labor. I did that. And I just kept losing weight. So very cool. I also recorded an episode that is up already about the kind of hollow feeling I have, as I'm eating less and less and hollow meaning like, like a loss like I'm not like I don't have as much to do because I'm not cooking as much and shopping as much and all that stuff. If you want to hear that it's actually with Erica Forsythe. And it's episode 919 It's actually we go V diary two, this will be I think we go the diary three. Anyway, things are going great. I'm taking my supplements every day vitamin D, magnesium oxide, I take a probiotic, I take zinc, that all is just going along very well. Some mornings, I have a yogurt. Some mornings, many mornings, I have an egg with maybe like a piece of shrimp or two or piece of chicken a couple of ounces of chicken in a wrap. It's probably because of the wrap of 40 carbs. Middle of the day. Some days I've been having like a small sandwich salads you know, just it's not a lot of food. I don't know another way to put it. Again, I'm still not hungry at all. Don't think about food, although I did have the experience. After working outside all day, like I got up I had an egg wrap. I went outside, I worked all day I had grabbed a banana in the middle of the day because I felt a little like hungry, like not hungry. I felt tired. Like I was hungry. But I didn't have hunger. So I had a banana. And I got done in the evening. And I was wasted. And I was like I had that, um, it felt like like just released from prison hunger, you know, where I sat down, stared down and just ate. But I had like a can of like chicken soup with a few saltines in it. And I couldn't finish it. I was like, not I was ravenous, like head hungry. Not belly hungry, which I think I've explained well enough already. Like I knew I needed sustenance. Because I was just like, you know, zoning from all the work. But I ate ravenously like an animal, but then couldn't get it all in. Last night actually had a slice of thin crust pizza went in very well. And no heartburn. That's another thing I should bring up as times passing. I'm not having like I was having heartburn a couple of weeks ago. Remember after the cheesecake, that's not happening nearly as often or at all maybe this week. I'm gonna have to keep better track of that. I don't remember it being an issue this week. I think that's about it. I'm going to do the injection. We go v one milligram. All right. Here we go. You're ready. You're like yeah, I'm not injecting and I don't care stuff. Here we go.

All right. Well, I can't tell you I'm excited. This is the ninth injection I've done. Four point twos, four point fives now a one milligram and I so far could not be happier with this. The weight is still coming out of my midsection, my chest, my back. love handles belly. My arms and legs all look fairly similar. My face still hasn't thinned out much. Which is funny because everybody talks about like ozempic face and I don't I don't have that yet. Actually, I would like a little bit of it a little chubby and my face still hopefully some of that comes out. I have no idea where this is gonna go but 20 pounds in two months is a triumph. In my opinion. It has been easy, and it really has changed. Like my day. Like you know, I'm not as involved with food even though I wasn't before. And somebody asked me the other day about I said oh you could pick that up at Wawa. It's a convenience store around here. And I said I can't think of one thing in that store I could eat or want to eat and that's just not like you know we used to get sandwiches there like at baseball games and stuff like that and grab like chips and drinks and and now I think about that store. I couldn't there's nothing in there I want not a thing. It's amazing. Anyway, Novo Nordisk makes this stuff thank you Novo Nordisk, you should buy ads because I'm a fan. This next check in comes from the patio of a hotel that I was staying at. It's little noisy and will sound a little different, but at least I remember to do it. Alright everybody it is Tuesday, May 30. I'm about to take my one milligram we go V can you see that? Anyway, I'm in Georgia, we're getting ready to pick up art and after her freshman year of college has ended which will just be happening in a day or so. But it's time to take my we go v. And I thought I would tell you about it. Just like I have been so cap off. But it looks like if I can do this with one hand, probably can pick up my shirt

Okay, anyway, I don't know how much weight I've lost this week, because we left on this trip. Let's see, what did we leave for this trip? Thursday, Wednesday or Thursday, last week, it's Tuesday already really nice day here. We spent a few days with our son. And now we're here picking up Arden. And Canvas, might we go V, I can tell you that my hunger is exactly the same, which is to say none. eating at restaurants you just have to kind of be careful pick through the menu a little bit. I've ordered some things that I haven't been able to finish, obviously a big deal. Kelly and I have been splitting food instead of ordering our own. What else I appear to be losing weight, I feel terrific. That's about it. I guess. I'm gonna put this audio in with the diary that you'll be hearing on the podcast, probably in about a week or so. Hey, everybody, I'm back. It's June 6. I'm about to do my third injection of one milligram but I'm going to tell you some kind of exciting stuff first. So as you heard a minute ago, I left my house on a Wednesday and didn't return till the following Friday. So all day Wednesday in a car. Thursday we went to professional baseball game with my son saw the Braves in the Phillies play. I avoided ballpark food but I had some grapes. More importantly, Wednesday was travel time and a restaurant, Thursday, Friday, Saturday, Sunday, Monday, Tuesday, Wednesday, all restaurant days. Now I was careful not to eat fried foods or anything fatty or weird or anything like that. I felt great the whole time. But I didn't really know what was happening with my weight. Because obviously I wasn't weighing myself was getting a little more exercise. But overall I felt good the entire time. I didn't have any trouble eating in restaurant had to be careful. Get a turkey sandwich here have half of it. little bowl of soup, stuff like that. Anyway, I got home and weighed myself on Saturday morning. And I was only up like a half a pound. I'm telling you that if I would have gone away like this without we go V I would have come back five pounds heavier. But instead, no real weight change. Now today's really my first day getting back into it kind of slowly drift back into life, went and saw a movie that spider verse movie is terrific, by the way, did some other things like that? Getting the house settled down getting Arden booth back in. But now I'm back on it now back on my regular schedule back on my regular eating habits. So we're gonna see what happens. But I did weigh myself this morning. And I weighed 213 Let's say yeah, 213.8 pounds. So that is officially only point four pounds heavier than my lowest weight so far. Back on 523, that's may 23. I was to 13.4. Since then I've got a couple of weigh ins to 14.6 to 14.8 to 14.2. And today to 13.8. Sorry, taking a drink. It's early here. That's a major success in my opinion. So I can't wait to see where this goes after this. But for now I've got to do my injection. one milligram of weego V still putting it in my belly. Still have a belly to put it in. But I'm actually I'll tell you this in a second. Let me inject this first. Here we go.

Okay, what do I want to tell you? I saw some graffiti while I was away. And it reminded me Hold on, I'm taking off the injection thing. There we go. I held it longer, I always hold it longer than I'm supposed to just to make sure. I saw some graffiti that reminded me of live from a recent afterdark episode, live with me. And I took a photo to send to her. But I jumped into the picture. And my wife took the picture. And I'm 100% being honest with you. It's the first photograph in maybe 15 years that I've seen myself in where I was comfortable with it. That was pretty much all I wanted to say about that was, it was a leading to look at the picture and think I would show this to people. And then after that I had the realization that I have at times not gotten in photos with my children and my family because of how they would look. And that was pretty heartbreaking. Anyway, okay, what happens now is I emailed the doctor to tell her that I've taken my third injection of one milligram, she starts the process of writing a new prescription for the step up, I don't actually remember what the step up from one is, but you'll find out soon, I have one more injection of one to go one milligram to go. And so you'll hear me again in just a second, a week from now, I hope you guys are having a great day, and you're enjoying the diaries. On the next installment, I'll go over all of the different measurements that the scale makes. So like, you know, water weight, etc. This role fat, blah, blah, blah, blah, blah. Anyway, I mean, you're gonna hear it right now. So I probably didn't have to say, Hey, everybody, I'm back. It is June 13. And I am about to inject my last dose of one milligram of weego V. But first, let's see about the measurements. This was an interesting week, my doctor put me on an oral iron replacement, so that we're trying to keep my iron from falling again. But it was too much too significant was too severe. But it was too much constipated me just gonna come out and tell you that. So that kind of threw the whole week off here with B, go v a little bit wasn't losing weight, I realized the iron was having the impact. I stopped it add a little extra magnesium oxide to get things moving again. And then all of a sudden, I was like, I'm losing weight again, I'm gonna lose a couple pounds this week. But then I had a sandwich now. I think this illuminates food choices really. I had this feeling all day I got up in the morning I had a yogurt and an egg. And like a little rap. That's like I'm gonna go to the store today and get a turkey breast and I'm gonna bake it and then slice it up and make a small sandwich. But they got away from me and I was never able to do that. But I was still thinking about the sandwich. At the end of the day. I was hungry. It was time for dinner. And I went to a sub shop instead and bought a six inch turkey roast beef with a piece of cheese on a roll. And I woke up the next day, like almost a pound heavier. And I thought I mean, alright, it's a little bit of bread, but I've had bread on this diet before I've never put weight on. I think it's the salt in the deli meat. Actually think I'm retaining water from the salt, the deli meat. Anyway, the measurements. So we started this whole thing and by way, I guess I mean me and then me telling you about it. Let's see, march 28. I hate doing this on March 28. I weighed 233.4 pounds. Today, June 13. April, May June, not three months yet. Just about maybe another week. 213.2 pounds, so that's 20.2 pounds, but two days ago I was 211.6 So two 12.64. So I put like a pound and a half on with the sandwich and you know, I don't know whatever else not going to the bathroom regularly. That's just a little look into that. My BMI right now is 31.6 Wow, it started at 34.6 body fat 30.1 started at 35 This is interesting. My hydration continues to go up today. It was 50.4 I started 47% I still don't completely understand the connection between losing fat and hydration but maybe I'll figure Read up on skeletal muscle from 42 to 45.1. BMR 1856. It began at it's 1822. Now, my fat free body weight is 140 8.2. But it started at 150 1.8. Does that mean that without fat I'd weigh 142 pounds is what that means. subcutaneous fat began at 30 is 26. Now, visceral fat began at 17 is 14. Now, muscle mass is dropped a little, which you expect with dieting. with weight loss, excuse me started at 144 and is 140. So, bone mass 7.6 to 7.4. That's nominal. My protein is going up. I don't know how I don't know how the scale knows this. But 14.8 at the beginning 16 now and my metabolic age has dropped still just one year from 58 to 57. Which of course is concerning because next month, I'll be 52. But maybe that will keep going down. Alright, so those are the numbers. I'm gonna tell you a little something about hunger in a second. But first, let's, let's shoot this week. Ovie? Shall we, I just keep putting in my belly. And that seems to be fine, right? Yeah, what the hell that's working. I haven't said this in a while. Here we go V. Y is that point they make ads, you can have that for free. Here we go. He's genius. Here we go.

Okay, well, that was pretty easy. Just holding it in for an extra second or two. Because you know, I'm used to doing that with insulin and needles like to get it all out. And we're done. So I'm saving all the pens. I don't know why. There's a little box here at my desk. A hunger. Yesterday, had been obviously six days since I had my last shot if we go up. And I have to admit, I was able to eat a sandwich that I would not be able to eat earlier in the week. What else I want to talk about about food. Oh, when you get constipated, the slowdown throughout your entire system makes you feel made me feel a little more. I guess some people might call it nauseous. But just like your food's not going all the way down like it's got nowhere to go. So what I've noticed is, if you have that feeling, going to the bathroom can eliminate the feeling number two now number one. And you do have to be very careful about not eating too late in the day because I'll get acid reflux if my foods not digested before I go to sleep. So at this point now, in honesty, five or six o'clock in the afternoon is the last time I tried to have solid food or something that's going to sit in my stomach for a while because obviously the medication makes it stay there longer, slows digestion. Last thing I want to tell you is that I went to the doctor on Saturday, a little follow up for my week OB and she was just like, wow, you're great. She said I looked younger. That was nice. I was two people have told me this week for the first time that I look like I've lost weight. One person said did you change your hair? And I don't think they were being polite. And one person just looked at me from across the parking lot and yelled go skinny, what's going on? That was better. I enjoyed that. Thank you for that person. I am not skinny, by the way. But what I have figured out is that I don't think consciously, but I've lost 20 pounds now. And if you would have asked me before I started doing this, how much weight do you need to lose? I would have said 20 pounds. And now I see myself and I think oh boy that was either generous or a lie. Not sure which but I do think that you can slowly start to just accept things, even visually or how you feel. Maybe you make excuses for them along the way. But I definitely need to lose more than 20 pounds for my own health like forget how I look. I will tell you that I feel better My back feels better. My feet feel better, my knees feel better. Generally speaking, I have good energy. I think a lot of this has to do with the decrease in mass that I'm just carrying around all the time. Anyway, I hope you guys are enjoying this. I think I'm gonna button this one up and start a new one with the first injection of the next step up. So I'm gonna go now, but I'll put this up for you soon. Maybe this week even? Yeah, maybe I could do it on Thursday or Friday, at the very least on Monday. You don't care about this part. This is just me thinking about my schedule now. Thank you so much for listening. I'll be back very soon with another episode of The Juicebox Podcast. This week, we'll be WorkKeys they should call workI they should call it work Covey, or I don't know what they should call it. But it really is amazing. I'm telling you, like i Two days ago, well, I'm sorry. I know. I said I was done. Two days ago, I got up. I had a yogurt in the morning. I'm drink drinking. I mean eating coconut milk yogurt, which is really good. I did not expect that to be good. But it was it is. And then it was like, three in the afternoon. And I thought, oh my god, I haven't eaten today. But I had no indication of it physically. Now, on Saturday, we decided to go visit some family. So we jumped in the car, and we're going out the door and I was like, I gotta take a banana with me because I'm gonna get hungry while we're there. And I grabbed a banana went there. And it turned out my banana was too ripe. So when I started feeling like well, I should eat something and I was like, Oh, this thing's nasty. And I put it down and I just did what I normally would have done. I'm like all eat later. But like 20 minutes a half an hour later. I said to my brother in law, I'm like, I'm woozy. Like do you have a banana in your house? Interesting. Like I started getting like dizzy. Banana fix it obviously ate a little something else. I had like a handful of something. I forget what it was a hard pretzel or crack or something with a banana because I mean, I was at someone else's house. I was just grabbing out of their closet. Anyway, you got to remember to eat on this, which I I feel like I should keep bringing it up. All right now I'm really going see

well, there's no one to thank because I was the only one on the podcast. So anyway, thank me for coming on the podcast being so open and honest about my week. Ovie thing. Yeah, that's probably too much. Now it's too late to go back. Thank you so much for listening. Please remember about the private Facebook group. Please remember that you can save 35% off your entire order cozy earth.com with the offer code juice box at checkout that you can get 10% off your first month of therapy@betterhelp.com forward slash juicebox and of course you'll get five free travel packs in a year supply of vitamin D all for free with your first order of 81 from Athletic Greens when you use my link athletic greens.com forward slash juice box. I'll give you a little bonus for staying till the end. I am putting this all together recording these bumpers for you two days after I just recorded the last entry and I am back to my lowest weight ever. Tomorrow morning. With any luck. I'll see a new lower number one

#934 iLet Bionic Pancreas with Ed Damiano

Ed Damiano is the Founder of Beta Bionics and he's here today to talk about the iLet Bionic Pancreas.

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Scott Benner 0:00
Hello friends, and welcome to episode 934 of the Juicebox Podcast.

On today's episode of The Juicebox Podcast Ed Damiano from beta bionics is here to talk about the iLet bionic pancreas. Edie and I had an almost two hour long conversation about islet. I got in a ton of listener questions. Edie told me all about the company, how things started, where it is now when he expects people to be holding an eyelet and so much more. While you're listening. Please remember that nothing you hear on the Juicebox Podcast should be considered advice, medical or otherwise, always consult a physician before making any changes to your healthcare plan, or becoming bold with insulin. Here are three quick ways you can save money. Your first month of online therapy betterhelp.com forward slash juice box Use the link to save 10% off that first month. The offer code juice box at checkout at cozy earth.com will save you 35% off your entire order. And if you want to try ag one, go to athletic greens.com forward slash juice box when you do you'll get five free travel packs and a free year's supply of vitamin D with your first order

this episode of The Juicebox Podcast is sponsored by us med us med is the place where my daughter gets her diabetes supplies from and you can to go to us med.com forward slash juice box or call 888-721-1514 To get your free benefits check us med always provides 90 days worth of supplies. And they have fast and free shipping. They carry everything from insulin pumps to CGM diabetes testing supplies you want the libre to the libre three, the Dexcom G six or Dexcom G seven US med has it. You want Omnipod five you want Omnipod dash us med has that too. They have tandem T slim x two. Oh my goodness, they have it if you're looking for it, US med.com forward slash juicebox. Before it comes on, let me tell you two things. There are some ads that are in this episode. But I'm not going to put them in the conversation there at the end. So if you want to hear them, please hang out. And listen, I appreciate that very much. I want to remind you to go to the private Facebook group Juicebox Podcast type one diabetes head in there. There's 40,000 active members. It is the most lively and lovely diabetes Facebook group known to man. That's my opinion. If you're looking for the bold beginnings, diabetes, Pro Tip series, type two diabetes Pro Tip series defining thyroid, all of the things that people who listen to the podcast love. If you can't find them in your podcast app, go to juicebox podcast.com. There's a menu at the top, you'll be able to find everything there. Or if you're in the private Facebook group hit the feature tab at the top of the group. If you have a question about diabetes, or autoimmune issues in general, we've covered it on the Juicebox Podcast. Welcome back, even though you don't remember ever being on the show. I barely remember talking to you, but you were definitely on this podcast in the first year of it. I cannot find in the list anywhere like what would you have been calling it eyelet back then?

Ed Damiano 3:34
No, no. So if you think it was 2015, we definitely had give my wife was the one who named it the eyelet. I called it the bionic pancreas before we had the name islet and she came up with the name pilot. And I think that happened in 2013 is my guess. But we weren't you know, we were using both terms sort of interchange, there was no company in 2013 or even 2014.

Scott Benner 3:58
Wow. Well, so then how did I? Well, how did this all start? I'm assuming you or your child has diabetes, right?

Ed Damiano 4:05
Yeah. So that is how I got involved with this. So my, my background is an applied mathematics. And specifically I do what I would describe as mathematical biology. That's what I used to study. And what does that mean, I would you know, I was looking at mathematical models of how the inner ear works and fluid structure interactions that happen when you move your head through space, the vestibular system and your sense of balance and equilibrium. Understanding the underlying mechanics of that was very much a mathematics problem. And I spent some time working on that, I got very interested in blood flow in the very smallest micro vessels in the microcirculation blood flow through capillaries and understanding various important physiological phenomena that are connected to blood flow in micro vessels. And that became a big part of my research effort. And that's kind of what I did it was extremely theoretical, not not, not the least bit Practical, you know, I would write published papers in the Journal of fluid mechanics and, you know, PNAS and things like that. And, you know, there were three people who read the papers, and I was two of them. You know, that's what I used to say. So it was very, very arcane stuff and, and I enjoyed it very much. And certainly I could make a bit make build a career around it. But when my son developed type one in infancy, he was 11 months old, it became pretty clear that, you know, I had some basic skill sets that I could lead to the problem of building a device that could control blood sugar levels. And I had a student at the time, Feroz Alkhateeb, who was he was a PA, he was a master student in my lab, and he just come over to the US and he was doing some work in my area of blood flow, I had him working on a problem that he wasn't much interested in, frankly. And he'd finished finished his master's thesis, and he's sort of looking around for something else. And just five months after Ross arrived, David develop type one he was, as I said, 11 months old, my wife's a pediatrician. And she actually made the diagnosis. And I turned to fear also a year or so later saying, Listen, I've been thinking about a device that could deliver insulin and glucagon to automatically regulate glucose and people with type one. And at the heart of that is software is smart, intelligent software that determines how much insulin and glucagon to deliver, to get good glucose control based on a continuous stream of data from something like a continuous glucose monitor that didn't really exist in 2000, or 2001. Or two, there was a gluco watch, you may recall the sickness gluco watch. That was in 2000. And that didn't work particularly well, but it did get FDA approved. And so I envisioned that we would build the software that makes those those dosing decisions. And he got really interested in that as such, offered that up as a potential PhD project, and that became the summon substance of his PhD. And that was around 2002. So a little over 20 years, we started thinking about what that centerpiece, you know, technology would do, how it might work. And he started working on developing the mathematical algorithms. Initially, it was a single algorithm now we have three separate algorithms that run in parallel on the island. And that was at that time, he and I were at the University of Illinois, I was a professor of mechanical engineering, and this is in Urbana Champaign, and he was my PhD student. He finishes his PhD under under, in my lab at at ui UC Illinois and then I went to Boston University in 2004, took a faculty position in in Biomedical Engineering, Feroz, came over to Boston and did a postdoc in my lab. It's this fear still works with us today at beta bionics. So he's our VP of research innovation. And, and so he stuck with this project from the very beginning, we came to BU and started animal studies looking at glucose control with the algorithms that he'd been developing for his PhD in pigs that we could induce diabetes like pathology in and we could test the system in, you know, basically pigs with diabetes. We did that for about three or four years. And then I met Stephen Russell, my clinical collaborator of many years now 17 years, I think, in 2006 at MGH at Joslin diabetes Center, he was doing the fellowship he was doing as a postdoc fellow there. And so we started collaborating on bringing that system to human trials. And by 2008, we'd started clinical trials at the Massachusetts General Hospital Clinical Research Center in the inpatient setting.

Scott Benner 8:33
While you've been talking, it occurred to me, I don't think you've been on the podcast.

Ed Damiano 8:38
I mean, I totally believe you if you said it either way. I

Scott Benner 8:42
like something about when you said Boston, it hit it hit me and I researched. I researched not research, but read dash search my my blog just now. Yeah. And in 2016, January, a woman named Kelly was on to talk about being in your trial. That's what this is. Yeah, that's

Ed Damiano 9:03
much later and

Scott Benner 9:04
your name like, rings my bell because of that. And obviously, I know who you are, like, you know, we've never met before. I know your face. You and I have never met before. And if somebody asked me to describe you, I could do it. Right. I'm not aware of who you are. But yeah, I think that's what I was thinking of. Wow, that was Yeah, no kidding. Okay.

Ed Damiano 9:23
I mean, I've done a lot of interviews, as you might imagine. And so I could easily be convinced that I given an interview to just about anybody

Scott Benner 9:29
I want to be, I want to be completely honest, there are lovely people who helped me with the Facebook group. And if someone asks a question, I'll say, I don't know Have I ever said that and somebody else will have to come in and tell me if I said it, or I'm beyond being upset or or embarrassed by that. So that's how you get this whole thing going. That's fascinating, but my daughter was two and she was diagnosed like right after her second birthday. I do not meet a lot of people whose kids were younger than that. Usually.

Ed Damiano 9:56
No, it's extremely rare. I mean, I think it's, you know, probably Just a handful of people who are diagnosed under the age of one with actually with type one, you have some kids who get this congenital, this congenital, this neonatal diabetes. That is something it's exceedingly rare but it happens and it's often misdiagnosed as type one. We actually thought David might have that but neonatal usually see that around six months of age and he was around 11 months, so he was actually old for neonatal. We did some testing and it was pretty clear that he doesn't have neonatal as type one. But he's been on an insulin pump since 13 months of age. Wow. Which

Scott Benner 10:33
one? Did he have them? Mini med fiber? Wait.

Ed Damiano 10:37
We used his old mini med pump in the big studies. So once he graduated to the Animus we took his mini med pump and put it into big studies. Yeah, about that. Do you have other children? Yeah, my, my daughter is two years older than David. So she's 26. Now David's 24 And she's about she just finished grad school and she's gonna go into another grad program in the fall.

Scott Benner 10:58
Wow. Any other autoimmune your family? Yeah,

Ed Damiano 11:01
Emily herself. She has celiac disease. Okay. So that was diagnosed. Toby was doing a workup on her just for short stature. And she thought maybe she should be able to taller. And she, she ended up having celiac that's sort of in the, in the, in the panel when you look at look at that kind of thing. So she, she was around 12 or so when we figured

Scott Benner 11:23
that out. My daughter was the smallest person in her school. And we figured out she had hypothyroidism and she's 18 now and she's 570

Ed Damiano 11:31
Good for you. So she did just fine. My wife's five, seven.

Scott Benner 11:34
We went to good height. Yeah, but we got it. I mean, I'll never know what would happen if it wouldn't have got caught but it was hard not to catch. She was like basically passing out like asleep. She had no like energy and no energy at all. Yeah. But it was just really something like, she was the tiniest little person. And then now she's just isn't it's really something else what the right, the right thing can do to help you. Alright, so that's got to be enough. Everybody's like, just ask the question, Scott.

Ed Damiano 12:07
Well, we certainly have a kinship there with a very young person and you know, to watch it through infancy, diabetes progress through infancy and toddlerhood and, and, you know, preschool age, and then the school aged kid and the teenager and now the young adult, to see that whole arc pass before me over the past 20 years is quite amazing thing.

Scott Benner 12:26
It gives you a perspective that a lot of people don't have either you can kind of really step back sometimes and see all of the different impacts that I think get lost on people from time to time. Yeah, yeah. It's, it really is held been a hell of a journey. Okay. So, modern day a few weeks ago, I was speaking at an event, I met Stephen Russell, right. He works at UC did. And he was like, you know, spilling the beans that you guys were about to get an FDA approval. So tell me about that process a little bit. So once you say we've got a thing, it works. This is the thing we want the FDA to say yes to? Like, when was that? How long? Have you been at that part?

Ed Damiano 13:07
Great question. So I think it'll surprise you. In order to be really ready to submit an application to get market approval or market clearances, it's called by the FDA for this device, you have to have a clinical data set that is collected in a pivotal trial. And what that means is that you you conduct a study that you design with the FDA, you work with the FDA to design what that trial looks like. And it has to you have to capture data in such a way that you're you've got a good quality system wrapped around it and you're pulling the data. Together, we use the Job Center for Health Research as the contract research organization to help us put that package together. And then you build a clinical clinical study report at the end of the trial. And the Job Center puts this together you know, we have input into that that document, but ultimately, once the clinical study reports are written that has all the data that was captured from that pivotal trial, and all the other testing for the device is done, which is enormous amount of work as you're building the system from scratch the eyelet is in fact device it's built at beta bionics not by contract manufacturing, we build in our own facility in Irvine, California. And building a device is a non trivial task, a durable medical a piece of durable medical equipment. And so it has its own quality system wrapped around it. We have a manufacturing process at debated bionics to build the system, and then in undergoes an enormous amount of testing all kinds of tests that were done for insulin pumps also had to be done for a bionic pancreas, along with this clinical data set that was captured to this very large pivotal trial, you pull all that together in a document that is 10s of 1000s of pages long, literally. And we submit that to the FDA. So the clinical trial, the data needed for that trial was collected was was basically in hand in December of 2021. Okay, all right, so the trial mode the trial the substitute trial happened to January in October of 2021 and the jibs And it worked really quickly to lock the database after the last participant last visit in October of 21. And within really, essentially, within two months, they had the readout of the of the primary outcome analysis that we were, we were waiting for. We were very pleased with the results. And then went the process of building the clinical study report into the early spring, early part of 2022. Okay, and so by 2022, we were 20, March of 22, we submit the application, and we got clearance in May of 23. So 14 months later,

Scott Benner 15:31
I'm gonna forget the I don't know the terminology. But were you able to claim that your device was similar to another device? Or did you have to start from scratch?

Ed Damiano 15:38
No. So we used I hope you're not getting this guy doing some yard work here. I'm hoping not getting that. Hopefully you're editing concat do something magical.

Scott Benner 15:49
Is it seems okay. Yeah, I think all right, microphone I made them send you is very close to your face. So

Ed Damiano 15:55
yeah, I think it's working well. And I've got the headset, everything I can hear up as long as you can't. That's great. So yes, the the hybrid closed loop systems on the market today, we could use one of those as the predicate device to as they call it to our application. And so the FDA suggested that we use that as the predicate device. And we went forward with that, that submission with that in mind.

Scott Benner 16:17
So are you able to get the device okayed, and the processor created at this, then the algorithm at the same time? Or did you have to make the pump, prove the pump work, and then step forward and do the next piece?

Ed Damiano 16:30
No, in fact, we had no intention of ever building an insulin pump. And I really want to make it clear that the bionic pancreas isn't an insulin pump. And really, and that's not just that's not just semantics, it's really not, there is no way to program Basal rates, carbs, and some ratios or correction factors on the island. There's no setting of parameters like that. So you can't operate the island in any configuration other than closed loop. So it's every 100% of every dose is determined autonomously by the device. And even if the CGM goes offline, you enter fingerstick measurements to keep it going. And it will use the fingerstick BG to determine the dose at the time if necessary, and dose automatically at that time. The more finger sticks you enter when the CGM is offline, the more glucose better glucose control you can get, because it can have has more opportunity to check in. But it gives Basal insulin when the CGM is offline because it figured out the Basal rate. So there's no insulin pump under the hood like there is with hybrid systems. There's no manual mode to go through this thing. There's no manual mode. And why that's important, is because there's a number of reasons why it's important in the context of your question. Every other hybrid closed loop, oh, the hybrid closed loop systems. And I would say the iLet isn't, isn't that. But the hybrid closed loop systems started as insulin pumps. And they all started in a world where you didn't need clinical data. Insulin pumps don't require clinical data, they require what's called human factor studies where people come into a conference room, they won't hook up to the device, but they'll go to the user interface and show that they can do the basic functions. And then if that human factors report goes into their market application, so the tandem system, the TCM pump, for example, the Omni pod five, the Medtronic system, the Omnipod, not five, but the early Omni pod system, and the Medtronic insulin pumps all went through human factors testing, but they didn't require any clinical trial data, we did not make a user interface where the islet could be a standalone met and manual insulin pump, in which case, if we had done that, we could have put that through the FDA a few years earlier, had a manual insulin pump and would have needed a clinical trial for that product. But to add the algorithms needs the clinical trial, we did it all simultaneously. So not to

Scott Benner 18:29
be too obtuse, but basically, the islet is like a self driving car with no steering wheel and no pedals. And the algorithm you get it drives you where you go. That's not

Ed Damiano 18:38
obtuse at all. Those are that is the that is exactly the analogy I make all the time. Okay, great, right. So it's like sitting in the in the passenger seat of a self driving car, you can't adjust the insulin dose, you can't, you can't override an insulin dose, you can't give a Bolus, right, so you can watch the thing, control your blood sugar, right, you can watch the self driving car go. And you can watch it, turn it steering wheel and so forth. But it really is determining 100% of every dose. Now you can interface one way to interface with the device is to let it know that you're having a meal and we have something called a meal announcement, which we can talk about. But even that when you issue a meal announcement, you're not determining the size of the insulin dose that is delivered in response to that. It figures that out by itself. And then it comes to know what that appropriate dose should be when you give a meal announcement for breakfast, lunch and dinner. And then it cleans up the rest downstream of that we can talk a bit more detail about how that works. I think it'd be a worthwhile thing to talk about. I

Scott Benner 19:37
know for certain I have one more question about that. Then we can definitely move on. Am I wrong? Just say that in the very, very beginning. You imagine this happening with a tandem pump?

Ed Damiano 19:46
No, no. Yeah. So no, no, not No at all. Actually, in the very beginning. I imagined it happening with something called The Aviator pump resume. You've never heard of that. So Dean came in had built a pump that was So 510 K cleared in a traditional insulin pump, and he licensed that to Abbott diabetes care. Abbott had a possession of this Abbott navigator which my son used from 2008 to 2012. It was in the US at that time. And it was a continuous glucose monitor. Phenomenal one, really. And the notion was we were working with the guys at Abbott, to put our algorithms in between the aviator insulin pump and the navigator CGM. And we would be the smarts in the middle. And what happened was Abbott had a change of heart. And they they did not proceed with the aviator pump. They never marketed even though it's 510 K cleared and they the navigator itself. They abandon that product in favor of what is now believed right in Flash glucose monitoring. So I found myself without a partner. I never intended to start a company never intended to build a hardware platform. My intention was to take the software that Feroz and I were working on and collaborate with Steven to test it and human trials and then license it off or be you Boston University with license that off to an abbot or a Medtronic or a tandem. So we did start talking with tandem. He's one of the reasons tandem is called tandem, as I understood it from 2011 is because they were always contemplating multiple fluids pushing multiple fluids, not just one. Okay. And so there was great interest in in a dual chamber T slim pump and I was working with a guy named Sean St. Who is now our current CEO at beta. Sean 2000 companion. Am I right about that? Well, he was not when I met him. When I met him. He was a young whippersnapper, engine engineer at tandem diabetes in 2011. And he approached me at an ADA conference. And he said we're about to get we think we're about to get 510 K clearance for the T slim pump, which he was right few months later he did. And I started working directly with Shawn in 2012 to build our first mobile device that ran on an iphone four s and commanded insulin and glucagon doses out of two independent tandem T slim pumps. And the woman Kelly you interviewed would have used that system. So you put two TCM pumps in your pocket one delivered insulin one was repurposed to deliver glucagon and this giant brick that an iPhone for us on one side and a G for Dexcom. Receiver all bundled together. Right. And that was our iPhone, bionic pancreas for about eight years. We use that thing.

Scott Benner 22:20
Wow. Wow, that's something look how far it's come and how long it takes us? Yes, a little humbling. Actually.

Ed Damiano 22:27
It For Me in particular. I mean, I never expected this first one never expected to build the whole thing or build this build the team that built the whole thing. But I never would have expected it would take as long as it did and cost as much money as it did. Yeah. It just it's just a huge undertaking of infrastructure to do something.

Scott Benner 22:45
It's funny, because when you talk about the first idea, like it occurs to me couldn't, couldn't any pump company just accept a bunch of algorithms from a bunch of different places and say, Look, just choose the one you want to use. And we could adapt, but I guess nothing. Everybody wants to be proprietary at some point, right. But it's

Ed Damiano 23:02
not just that you're right, that has historically been the case. But until recently, the FDA didn't make that easy. And they and the FDA sort of wanted to get out of its own way. It didn't like the fact that there are all these different companies making algorithms, mostly academic groups back then. Right? Not so much companies, but mostly academic groups, and companies were licensing algorithms from academia. But then you had a few companies making pumps, and you had a few companies making sensors. And so initially, the idea was at the FDA is that we want these sensors, these continuous glucose monitors of which there were like three on the market and now they're there a few more to be able to talk to any one of these pumps. Yeah, and integrate with any one of them. And then they evolve their thinking to say Okay, now let's allow these pumps you know, the a certain type of pump to not only talk to any one of these CGM, which they call they dubbed I CGM, you know, inter operable continuous glucose monitor. But then they wanted to, they made this thing called ACE pump, which was a device that that could talk to anyone these icy GMs and could host algorithms. And you could just plug and play this ace pump can work with this IC GM, that one or the other one. And this icy gem can work with these three A's pumps, and that they wanted that interoperability. And then they said to sort of flesh it out. The third technology in this piece right in the system is the are the algorithms and then they came up with something called AI AGC inter interoperable automated glucose controller, which was one of these plug and play algorithm 510 case or market applications. So now, you could have an AI AGC tested in one ace pump with once I CGM and once you do the clinical data, collect the clinical data for that ace pump IGC you could put it in different ace pumps without having to do another clinical trial. And you can make a talk to other ICBMs without having to do another clinical trial. So they're trying to be able to really promote this interoperability and all this different cross communication in this in this ecosystem of C GMs pumps and algorithms. And so they gave birth to all of these these three different regulatory pathways. And now we have an interoperable space that for the first time, now that as of just recently, in addition to the G six Dexcom, which is a, you know, II CGM, there is now the G seven Dexcom on the market, which is an IC CGM. And there is the libre three, which is an IC GM, it's the first time we've had more than one. I CGM out there.

Scott Benner 25:26
Right? Did you ever consider licensing it to pump companies? Or was that that's

Ed Damiano 25:31
what I wanted to do is what you that was my initial intent. And that's why I was working so closely with Abbott. And the problem with this was that when you start working with the med tech industry, the it can be it can be they can become quite capricious. And the reason is, especially big med tech, you have these divisions, diabetes divisions in these big med tech companies. So they do a bunch of things, right. But one thing they do is diabetes, and they have a diabetes division, and they have a precedent of that division. The president of that division, if they are very successful, very often gets promoted into some other space like cardiovascular within that company, leaving in that person's wake the need for his or her replacement. So another president comes in with totally different objectives. And they might say, you know, I want to pivot away from type one, type two, and this technology that my predecessor has been been investing in, I'm going to divest all of our interests in that and move into a new product, then they carve out their own little legacy for themselves. And so I couldn't rely on the med tech industry, I saw no way to do that. When there's that kind of capriciousness happening in the system. It's built right in right to the way these companies evolve.

Scott Benner 26:35
You don't want to spend six years turning yourself into the right quarterback, and then your coach leaves and he says, I want to run the ball more. And now. Now you're exactly I got it. Okay. Wow. I don't think I have any more questions around that part of it. I have.

Ed Damiano 26:51
I mean, there's a lot of history, right. And we can talk for an entire podcast on the history of this. Yeah, for sure. But the long and the short of it is we ultimately evolved our thinking through experience that we had to build this thing ourselves from the ground up and soup to nuts.

Scott Benner 27:04
And so I let because it's not an insulin pump, it needed a different name. So I that word just doesn't exist in your day.

Ed Damiano 27:13
Yeah, yeah. So it's funny because if you think about the evolution of the of my terminology, I go from the nerdiest of terms that you could imagine like a geeky engineer. And if you look at my slide decks from 2008 910 11, my, my terminology gets worse and worse. And I hit an all time low in 2011. So initially, I called it a closed loop blood glucose control system, which just rolls right off your tongue, right? And then I realized that that's just not, you know, it's a very academic, you know, thing engineer in particular would say things like that. And then I tried to come up with better terms. And I never liked artificial pancreas, because artificial practice tells you what it isn't. It isn't a real pancreas. And we know it's not a real pancreas. Can we have something that's more descriptive? So my ward, my lowest moment was when I called it a prosthetic pancreas. And I may as well just shown a picture of a little pump with crutches on either side of it, right. But in fact, it wasn't a I mean, it is a prosthesis, if you will, and in a way, but it's just not the right terminology. The next year, I said, What is it let's be positively descriptive, and not negatively descriptive, what it isn't. And then I looked, I thought about bionic pancreas. And then I looked in the dictionary, and it's you know, it's it's a technology that imitates you know, biological processes through through electronic electromechanical systems and electronic means it's exactly what we do. And so I coined that term in I think, 2012. And I've used it ever since. And that's kind of a category. It's a bionic pancreas, who my wife came along a couple years later and said, I know what the, you know what the device should be, should be called, it should be called an eyelet binding pack, because obviously an homage to the islets of Langerhans. Yeah,

Scott Benner 28:46
that's a great idea. Also, I don't want to get off topic before we get on topic. But how come you're an engineer and so personable?

Ed Damiano 28:54
I don't know. I mean, I think that AI engineers get a bad rap. You know, I think many of them can be quite personable. Excellent. I'm

Scott Benner 29:03
just like, well, you're like a good storyteller. And

Ed Damiano 29:07
you know, when you tell the story enough times it becomes

Scott Benner 29:09
rote? Yeah, I There are a couple things in my head that if I say I can shut off while I'm sending them off course. Alright. So you've got, you've got your clearance now, is it? I mean, I am assuming you're a smaller company. So what's it like? There's got to be a ramp up plan, right? Like you're gonna launch and then like, how do you foresee that going?

Ed Damiano 29:32
Yeah. So I'll give you a little bit insight into into, you know, our vision for how that should work. Remember, we did, as I said earlier, a pivotal trial. So we took the iLet. By the end of 2020. We had basically locked this thing into this little device that looks just like this thing I was just showing you. And we could then with funding from the National Institutes of Health, we had a large grant from the NIH to help pay for this study. It was what's called an investigator initiated trial. So beta bionics didn't spawn To the study, it was, it was basically sponsored by that jape Center for Health Research. The grant came in through my lab at Boston University, and went and dispensed out to 16 clinical sites. And so we had subcontracts sites at the university, North Carolina, Chapel Hill at Stanford University and masters, General Hospital, and so on and so forth. We had 16 sites. And we chose these sites carefully. Stephen Russell, myself, and Roy Beck sort of went through across the country and said, we really want to pick sites that can bring a lot of ethnic diversity into the trial. So we don't have you know, a study that's consistent, almost entirely of white, very wealthy, and very educated people, but rather a study that has a much better cross section and a better mirror of the population of the population at large. So we chose sites in northern Florida, in southern Texas, in Detroit, in Atlanta, Southern California, where we could get in a lot of ethnic diversity into our cohort and bring a bring a broader demographic into the study. So we designed that study with those 16 sites as the targeted places where they each bring in anywhere between 20 and 35 participants over the course of that 2021 calendar year. And that was really always my my thinking about how we should bring this thing out. We should start by using those sites as the places to launch the device. And when Sean St. came on board as CEO over the summer, you know, I think that jives well with him, he's like, Okay, well, I'll have we'll build a sales team. And they'll break up the country into sort of eight. It's a targeted launch, we break the region of the country up to eight territories, within each of those territories resides one or two of our pivotal trial sites from that study. And so those are the people who are in my mind, the de facto experts of using the island are the only ones have ever used it. In a close to real world setting our trial was designed to be a very good approximation of real world usage, people were on the device for 13 weeks. So they understood the device in a way nobody else could, until you use it, you can really understand and appreciate it. So we thought that was the best place to start. Now, in each of those regions, most territories, there are several other sites that are also going to participate in our launch. But we are moving very quickly. And because we're a small company, as you mentioned, we have, there's a kind of agility that we have, that allows us to go from getting 510 K clearance of a in a company that's never launched a product to launching the product within the space of about a month. So you know, we have certainly launched the iLet. It is, you know, the we have we're using a distributor distributor Durable Medical Equipment approach to distributing the device like like, like a traditional insulin pump would follow. And so we you know, we've shipped our product out to distributors, and they can in turn, ship those two people with type one diabetes and traducida, typically in those regions, and those regions covered a big section of the US, right? And so we just want to get our feet wet in the first few months and just get experience with the pivotal trial sites, and then expand and add territories in the fall. And then more sites as well.

Scott Benner 33:00
Do you see it as a years long project? To get up? Like when when Will everybody be able to walk into their doctor's office and say eyelid? Yeah, good question.

Ed Damiano 33:10
So right now at launch, we were we weren't able to get for example, Medicare and Medicaid Services to cover the device. You know, this is a device that you would, you would use private insurance and government insurance to pay for the device, you'd have a copay, just like a traditional insulin pump and similar similar with the supply with the supplies, but you can't we weren't allowed to negotiate with CMS Center for Medicare Medicaid Services. Prior to 510 K clearance, which we only obtained, you know, just less about four weeks, little less than four weeks ago, once we got 510 K clearance, we can start entering into a contract with CMS. And that takes anywhere between, you know, two and three months. So anybody on Medicare Medicaid Services, needs to know that we can't get it out to them right away just because there was no way we could have teed that up

Scott Benner 33:56
if I didn't have the conversation before the clearance.

Ed Damiano 33:59
Exactly. But with with with with commercial insurance, we were able to through the distributor Network Distributors across the country that sell insulin pump supplies, we were able to set up contracts with them. So the minute we got clearance, they could place an order. So we literally took orders right away upon FDA clearance that allows us to get out to a lot of people in the country in the you know, in the back half of this year, who have private pay. And we're hoping by say the fourth quarter maybe or maybe even sooner than that third or fourth quarter, we'll get government insurance on board once that contract sells and that allow us again to then penetrate further out and reach more people who do

Scott Benner 34:36
you see as your target user group?

Ed Damiano 34:41
The vast majority people type one but specifically, we see this technology is playing really well in the hands of people who are on MDI therapy in the hands of people who are willing to and I think this is most people will let go Have their diabetes management as much as possible. And what I would say is who it's not for, is who we call the knob Turner's and I would have to admit that I am probably one such person. Right? And yeah, I bet you are as well. Yeah. Right now, probably. So what do we do? Well, we have this little tiny child in front of us who has type one diabetes, and we are going to pour all of our energies into making sure this kids glucose is tightly controlled as possible without destroying their lives, right, we don't want to interfere with their lives so much that they're just, they're just a little experiment. So you have to do it in a way that, you know, they can coexist with this, but you want to give them as good of care as you can. So we were all over this little guy. And we grew him up that way. And he organically began taking more and more responsibility of his diabetes management. But I have to say that in taking over that responsibility over the course of a decade, to the point where he goes off to college with a animus pump, and a G six Dexcom, or G five Dexcom, back then he's doing a really good job managing his diabetes, and he is a tinkerer, he's going to adjust to fine tuning of insulin dosing, he's all over it, and multiple times a day. Now, many people who do that and do well with that are going to be able to use the eyelet successfully and comfortably, there may be an adjustment that they need to make and get used to handing the steering wheel off to some autonomous system. But they can sometimes make the adjustment. There are others who won't be able to, it'll provoke too much anxiety, and they just won't get through it. And the reality is, you don't know what sort of person you are until you try it. So living with the eyelid is the only way to find out if you can let go the wheel as he likes to say Yeah, and so we will offer a 90 day return policy with the island. So we want to make sure we really want to make sure that the right people find this device. But we also want to make sure that those who just find that the device is not right for them. Find a way to a device that is a loop system or more of a manual system where you get in, you know, you can take more responsibility for insulin dosing.

Scott Benner 37:01
Yeah, that's interesting. I mean, so what's the straight from the listener questions? What's the target a one see gonna be like, what do you expect the eyelet to pull for people?

Ed Damiano 37:12
Well, so our pivotal trial was, by the way, the largest pivotal trial ever conducted for a automated instant delivery system. It was a huge trial, and we enrolled children and adults simultaneously. So we went all the way down to age six, and all the way up to age 83. So we had a very broad range of ages. And if you typically the way you think about, you know, where the agency comes in, as you typically look at adults separately from pediatrics, it's very commonly done. In statistics you hear usually parse it out that way. So we found that the average a one see that the device achieved was about 7.1% In adults, and about 7.5%. In the kids. It's pretty amazing, actually, it's a really good one say, and we did not increase hyperglycemia, relative to the standard of care. And I think it's important to emphasize that the way we designed our trial was to have a standard of care study arm. So not everybody who went into the trial, use the eyelet right away. So what happened was there was a randomization, who you would use your screen to do the trial. And when you were enrolled, you would randomize the either the eyelet, which is called the intervention arm, or the standard of care arm. And by standard of care, we mean whatever your insulin therapy was, when you came into the trial, do that, but do it with a G six Dexcom. Now, if you were, for instance, using a CGM already, then we don't need to bother introducing a G six Dexcom. If you use the Medtronic, then that's your standard of care. You've got CGM, and we give you a blinded G six Dexcom. Because want to capture all the data ng six. If you're using a Eversense, or Liebreich continue doing that, but will give you a blinded G six. And if you didn't use any CGM, we taught you how to use the CGM, if you went into the control arm into the standard of care arm, and they became a CGM user, at least for that 13 week period. So the study cohort divided across these two groups. And because we had a standard of care arm, we could keep track of how well people did in the trial on their own care. And people tend to do better in clinical trials than they do on their own because they're being watched. They're being you interact with them more. It's called the study effect, the Hawthorne effect. And so we want to keep track of that. And whatever the eyelet does, it's really the difference between how much the you subtract out the improvement the standard of care arm saw from the improvement the eyelet saw relative to baseline. And that difference is the difference in the improvement of the eyelet. You can quantify the improvement and what we found was that it was statistically significant reduction in HBA one C of half a percent relative to standard of care. So we saw a point 5% improvement in Me included in a one C relative standard care on the island. And that was a statistically significant difference, which means that the likelihood that happened to chance is exceedingly small.

Scott Benner 39:55
How about if you take I mean, I heard you I heard the pride in your voice from us. said how you chose the people to go through these testings. And I feel like I understand the underpinning of that, which is that some companies pick ringers, like people who they know are gonna do a good job, right? How many times like how much data do you have about people coming in with just wildly out of control? A onesies? elevens twelves? Did they bring them to a seven?

Ed Damiano 40:23
Yeah, so it's an excellent question. So we were very careful not to have an upper limit on HBO and see, and that's unprecedented. There's never been an AI D study, where where there wasn't a limit on upper limit on HBO and see a pivotal trial. So we, you know, for for a market application for a device. And so we were really clear about this, we wanted to make sure that no more than a fifth, we asked the sites to limit those, those people that you randomize such that the limit limit or fill certain buckets, so make sure that at least a third of them have a one C above 8%. And no more than a fifth have an A one C below seven. And that's because these large epidemiological studies out there like the T Wendy exchange, and other studies have shown that on typically in the US, all these studies tend to corroborate that only about one in five people meet the American diabetes Association goal for therapy. Anyone see below seven. Yeah, that just is it just continues to ring true at least adults kids are even worse, unfortunately, having worse outcomes. But adults 18 and older, it's about one in five are achieving goal and 80% aren't. So we wanted to make sure our cohort as much as possible reflected that. So we asked the sites to try to limit the enrollment of Pupil tendency below seven. And to make sure you had at least a third they went above eight, we also wanted to make sure that at least a third of the cohort was on MDI at baseline. Right. So we didn't take pump users, you know, as as as exclusive requirement. We allowed people who on pumps and people who are on hybrid closeup systems to participate in the trial. So it was an FDA cleared device or an FDA approved device, it was admissible into the study. Yeah, I

Scott Benner 41:55
feel that when you mentioned earlier, it struck a chord with me because, you know, I had somebody asked me recently about, like, how do you stay so made motivated about making the podcast and I was like, for all the people I reach it's a very small percentage of people have diabetes. And you know, those other people are not running around with a onesies in the sixes, you know, and they they're overwhelmed. They don't understand what they're doing. They've long past given up and they're just they're on a they're on arrived with their eyes closed, wondering when it's gonna like come to a stop. And

Ed Damiano 42:28
I think the eyelid is for those people, the eyelid is for most of those people, it's not for everybody. And that on one end of the spectrum, right, as I was trying to emphasize the knob Turner's who are going to have anxiety by giving up control and can't get past that is not for them. And there are therapies. Fortunately, we have so many good alternatives. Now, there are therapies for that. But on the other end of the spectrum, you have to at least, you know, you have to attend to what Stephen Russell calls the care and feeding of the device, you have to make sure there's insulin in the cartridge, you have to make sure the CGM is streaming data, you have to make sure the infusion set is intact and working. Right. And you have to make sure the battery's charged. So that is a care and feeding level of responsibility that's essential for the aisle to help you. And they're going to be some people who won't do that either. And

Scott Benner 43:11
and also couldn't for reasons that you can't be pregnant use and I would imagine, because this is

Ed Damiano 43:16
not indicated for pregnancy, we did not test it in pregnancy. So that would have to be done separately is another try. Are there reasons

Scott Benner 43:21
that a doctor couldn't write it off label at some point for somebody under six? Are you going to have to do that testing before that gets okay?

Ed Damiano 43:29
Oh, physicians can write do anything they want with off label usage. They can use these devices, not just hours, but any of these devices off label, we just can't train to that. And we just need to be very clear. What is on label. Yeah. And what is on label is people with type one diabetes who are six and above, okay, who aren't and not pregnancy? So that's certainly not something we have an indication for.

Scott Benner 43:50
So So for clarity like, I can't use islet and achieve a five five a one C with there's no way for me to manipulate it or do that kind of stuff without Lowe's.

Ed Damiano 44:01
Ah, good question. So I noticed one of your one of your, some of your users had some of your listeners had a question similar to that. So what we found is about 46% of our adults had a mean glucose after 13 weeks on the island of about 100, about about 46% had a mean glucose under 154. And an agency of 7% corresponds to mean glucose about 154. So 46% of the cohort had a mean glucose below. Below 154. About 27% of the cohort on the island had an A one C below seven. So almost a third. So what does that mean? What was the lowest day when seeing the island? It was in the fives by the way. So we did have somebody who were those 13 weeks on the island, they ended with an A one C sort of in the mid fives, but it's unusual. The island tries to bring people's mean glucose and anyone see up a little higher if you're sitting down at what I mean glucose at 110 or 120. Right? You're likely going to see it increased toward 130 or 140 or 150. So it is that increase that some of the As folks who enjoy being down there, maybe they pay a price of hypoglycemia, but they want to be down there. Skimming the trees, so to speak, will be frustrated by that rise. But the reality is, all the clinical data suggests that there's no advantage to an agency of five and a half over an agency of six and a half. There's almost no signal for microvascular damage polonium exceeds seven, which is why these, you know, these societies like the Endocrine Society and American diverse decision, have these goals for therapies, goals for therapy.

Scott Benner 45:28
So, nuts and bolts. I want to go over just how it works for a second. So yeah, I'm going to eat a meal. Am I right? Like, I probably should just ask you, but my understanding of it is, and I'm assuming if this is my loose understanding, it's ever about a lot of other people's. I announced the meal by saying This is breakfast, lunch or dinner. And then I say whether this is similar, smaller or larger than I'm accustomed to eating, is that it?

Ed Damiano 45:53
That's it. Okay, so even rolling the tapes back Further still, to start the island on your own day zero, right, you get on the island, you enter your body weight. And that is it, right. So there's no programming of Basal rates, there's no programming of insulin correction factors. There's no programming carbs and some ratios. And there's no carb counting specifically, right, we do ask that you be carb aware. And I'll make a mention of that in a moment. But so to start the system, you enter your body weight, you have to learn how to hook up the infusion set and pair it with the CGM and so forth. But then you enter your body weight, and then you go bionic. And then you swipe to go down again, the system starts dosing every five minutes of every day and adjusts insulin therapy according to your needs to your ever changing insulin needs. But the meal announcement works as you describe almost exactly, to give you a little bit of color under the hood, as to what's actually happening when you do that. So with the meal announcement, you just simply swipe to unlock the device, and you just press on the little knife and fork. There's a little knife and fork here. And you press on that and it asks you, you know, is this you know, what meal type is it and you get to bucket breakfast, lunch or dinner. So given the time of day, I'm going to choose, let's just say, Well, it depends on where you are. Let's just say I choose dinner. And then it asks you is this usual carbs? For me more or less? So three buckets? And no numbers? No, mind you, right? This is diabetes without numbers. As a primary care physician that we've been working with, for years, who was really the one who coined that, and then you just simply, once you say, you know, usual for me, for instance, let's choose usual for me, then you just swipe, and it then determines the dose at that moment, and it begins to deliver. So what happens is it gives a dose of insulin at that moment. So if you have the food delivered, you don't pre meal Bolus, we discourage that, we ask people to wait until the food is in front of you not to worry about fat and protein, right, just focus on the carbohydrates on your plate. And by that I mean is this is this bowl is this is this lump of rice, the usual amount of carbohydrate I'd have for my lunch, say, or my breakfast or my dinner. And it will then on the very first offering of a meal announcement say for your first lunch meal announcement that you issue. It'll give a Bolus at that moment. Once you once you say usual for me lunch, for example. It'll give a Bolus based on your body weight initially, and it'll be quite conservative on that first attempt. And then it will watch every five minutes of the rest of the day, how much you know what your glucose does, and it will add insulin as needed, or suspend insulin as needed. And we have two other controllers that are running separate from the meal announcement controller, the one that gives that Bolus up front one we call the Basal controller or the Basal algorithm. And the other algorithm we call the corrections algorithm. And they're working in concert every five minutes and they adapt on multiple timescales to your changing needs. But the correction algorithm will add insulin above and beyond what the Basal algorithm thinks you need for your Basal requirement. And if it sees the blood sugar starts to rise, even in the in the face of that meal announcement Bolus that was just delivered, the correction algo will add some additional insulin. And at and tomorrow, when you issue another meal announcement for say lunch or usual for me, it will look to see yesterday when you did this, the meal announcement gave three units of insulin and then we added another three units of insulin of correction insulin in the four hours afterwards. And that was not the right balance. It wants the meal announcement to be a majority of your mealtime insulin over the four hours after the meal announcement. And if it was short of that, it'll make it a little bigger. The next day you do it a little bit smaller if it was too much if it was all of the insulin, and then they'll start adapting that and the body weight thing becomes less important. You initialize that with body weight but it's allowed to depart from that very quickly and start adjusting the size of that lunch meal announcement to be to account for most of your for our insulin but not all of it. And it separately adapts the meal announcement for breakfast, separate from lunch separate from dinner it buckets those three and if you have a snack, you know if you have an evening snack you might want to bucket that with dinner if you have a morning snack, you know a little left o'clock ish like Winnie the Pooh, you might call that a breakfast snack.

Scott Benner 50:03
Okay, right? Why doesn't it need a Pre-Bolus? Is it? Because, I mean, I've used a number of different algorithms with my daughter, but most specifically Luke and Omnipod. Five. And they they seem to have in common that once you put in insulin, they take away basil and then work backwards is kind of how I think about it. Does that make sense? To you stay understanding, is the eyelid staying aggressive when the Bolus goes in? Because you my daughter can't eat food without Pre-Bolus? Like whether I did it like so what is it doing? Is it is it matching the power of the rise with insulin and then getting the hell out of there before it causes a low?

Ed Damiano 50:45
Well, yeah, so what it does is it the Basal controller is a controller that adapts on multiple timescales. So let's just focus on that one. First, the basil algorithm, we call it, and it has, you know, it's adjusting sort of an average Basal rate that it figures out by itself over time. And there's an there's a, an ability of the basil algorithm to shut Basal insulin off completely, if you're starting to go low. If you are low, or you're tending low, it can turn the Basal Basal insulin dosing off completely. But it's adjusting this on a very short timescale, looking at your glucose levels, every five minutes, it's it's got to be very responsive, I'm going to turn off Basal insulin if you're dropping too fast, or if you're low, or it can just run along. And it also can see daily patterns. So it also adapts on a diurnal nocturnal timescale of 24 hours. And so we can see that, you know, suppose your child who has growth growth hormone secretion upon the onset of sleep at around 11 o'clock or 12 o'clock at night, and they tend to need more insulin because of that, because the growth hormone causes, you know, release of glucose by the liver. And so the Basal control will start to see that and it'll start to adapt upwards and it might see this pattern that typically around this hour of the day, I need more Basal insulin, it'll just sort of it'll, it'll see that pattern and it'll reinforce it. But if you change as you grow into a young, a young child, and then a teenager, and you start having a cortisol secretion, or just before waking in the dawn hours, you no longer have the growth moment at night. Now that shifts toward your needing more Basal insulin, say it five in the morning, it'll figure that out automatically. And similarly with intercurrent illness. So if you have an upper respiratory virus, and you see a sudden need for more Basal insulin or more correction, insulin for two or three days, it'll see that automatically and we realize that I've got to get more insulin to keep the glucose down at this average that I've been trying to achieve. So I will adapt upwards for that two, or three or four days or a week when you're more insulin resistant. And if you have a vomiting illness, you're very insulin sensitive, it'll do the opposite, it'll back off and become less aggressive. So it's doing the Basal controllers doing that the Basal algorithm and the corrections albums also figuring out your insulin sensitivity, automatically, not so much in terms of the number, what is your insulin sensitivity factor, but rather recognizing that this person over the over the days and weeks, months and years, their insulin resistance might change, they might need more insulin, when your blood sugar hits 250 than it used to when you were six years old, then then you need now when you're 14, and it'll suddenly start adjusting that upwards as well. And you'll get more correction and then on top of it, and it adapts on multiple timescales, not just five minutes in daily timescales, but intermediate timescales as well. And that adapting on multiple timescales allows these two algorithms to learn. It's really a self learning system, and allows that system to engage in what is essentially called lifelong learning. So it does see patterns on a daily basis and is able to adapt to your ever changing insulin needs. Meal announcements adapt according to how you provide input on what is tip usual meal for you breakfast, lunch and dinner. And you're

Scott Benner 53:46
comfortable calling it learning. It's not just going off of what it seen recently, but it's it's remembering stuff from the past.

Ed Damiano 53:54
Yes, it is. And so it is storing information from this past week on where your insulin needs were higher and lower. So it is a kind of an autonomous learning system. I wouldn't call it artificial intelligence. Right? It does. It does do some pattern recognition, though, in the sense that if it sees if it sees, you know that the basil algorithm is giving more insulin at this, you know, early morning hours over and over again, it will see that and it will, it will it will it will tend to be higher in that in that period, unless for some reason in that particular morning, you don't secrete the cortisol and you're more insulin sensitive, it can very quickly turn off the Basal insulin. So it is a learning system in that regard. Yeah, so

Scott Benner 54:32
that brings up a question that a lot of people ask them that. I was wondering just while you're talking us an idea like somebody's getting their period, like so one day like I'll use my daughter because I'm sure one day she'll love to listen back to this podcast and hear her period as much but in the days approaching, Arden can be need more insulin, and then when the event happens, she can fairly suddenly need less, and it changed his dress. So how Otherwise, how does like can I just like whisper in the eyelids here? Like, you know, I got my period or like, like, how does that like you because you can't tell it stuff like that,

Ed Damiano 55:07
you know, you can't tell and stuff like that. And it doesn't have it doesn't have memory over a monthly cycle, right? It's really looking more over the seeing patterns in the past week or so. But just to be clear, the eyelet learns and adapts very, very quickly. So what we found was in the pivotal trial, remember, we start the system with your body weight. So imagine you have a teenager, a raging hormone adolescent who weighs 70 kilos, and uses 90 units of insulin a day, and an adult who weigh 70 kilos, he uses 45, the islet will figure out that difference in about 24 to 48 hours that difference, that's fast, right? That's fast enough to handle the increased insulin demand around periods around intercurrent illness, the physiological changes in insulin demand happen over the space of a day or so it will see that and if you suddenly become very insulin sensitive, like you just described, it can shut Basal insulin off and it won't dose correction and insulin if it doesn't need it. If you're not hypoglycemic. So if it sees you sort of staying low, it'll back off completely on Basal insulin or or shut it down dramatically. So that if you won't go low as easily as you can go high. So it definitely is biased and trying to prevent hypoglycemia. That's like the first order of business is to limit hyperglycemia.

Scott Benner 56:24
How does that work with exercise?

Ed Damiano 56:27
So with exercise, I would like to introduce you to the idea of a by hormonal system. That is, indeed, unequivocally the best way to deal with exercise is that you know, is to be as biomimetic as possible. That is how the pancreas handles exercise. It reduces insulin secretion simultaneously with increasing glucagon secretion. And we really do need a by hormonal system to handle exercise elegantly in type one. All single hormone systems are vulnerable to exercise, even insulin pen therapy, all of it. Yeah. So you have carbohydrates to help and other other tricks to deal with that using carbs, you know, many carbs to treat, or being fasted going into exercise are different ways to deal with people different ideas about that. And many of those tools are going to be used with the single hormone island, but specifically, disconnecting from the device is what we recommend, if you're going to engage in exercise, just this is going to add the infusion set, if you're going to engage in exercise, that where you find yourself going low in on your other therapies, try disconnecting from the eyelet. There's no setting of temporary basals. But if you do have to go beyond that, and say it's not enough just to suspend insulin, I also need to usually take some carbs ahead of exercise, if you're going to carb load like that, to prevent hypose. during workouts, what we ask you to do is to disconnect from the eyelet first and then take the carbohydrates not the other way around. Because if you do the carb loading and forget to disconnect in your workout, it'll see the rise and we'll start dosing just when you don't want it working out. So the order is actually important there. And that's something a little different from traditional pump therapy.

Scott Benner 58:05
Okay. Would you say that the system if it's trying to address a higher blood sugar, for example, does it address it with Basal insulin or with a Bolus?

Ed Damiano 58:14
Yeah, so it has the correct the correction algorithm is responsible for giving insulin above and beyond what the Basal is, sees its responsibility to be the Basal insulin. The Basal insulin algorithm is sort of swimming in its own swim lane. And then you've got the correction algorithm that swims and it's swim lane. And when you start to have hyperglycemia excursions for whatever reason, stress hormones, stress, hormones, stress, you know, whatever is or an illness, or carbohydrates, right if you forget to meal announce or if you meal even if you do meal announcing you tend to see a still arise after that. The Corrections algorithms responsibilities to come in and give that additional insulin above and beyond Basal that handles hyperglycaemic excursions. And if you forgot to meal announced it will provide all of the additional meal insulin, if you will, it doesn't know its meal. Instead, it's just correction insulin needed to bring you back into range. But if you do forget to meal announce, it will step up and do that. What we tell people is that what we've seen is that typically, if you forget to meal announced and you eat a meal and it has the sufficient amount of carbs to cause a glucose excursion, you'll typically you'll likely go higher than you would if you did a meal announcement you'll be higher for longer and there is an increased chance of late postprandial hyperglycemia if you don't do the meal announced because the meal announcement gets the insulin up front, it's always best to get the insulin up front than to wait until you see the rise but it is designed to handle glucose excursions when you know nothing of any sort even those occasions when you forget to meal announce Okay,

Scott Benner 59:40
so here's another idea. What if I'm a very low carb person and I weigh 150 pounds I put on island a family 150 pounds and I'm eating breakfast and it's normal for me. Like but normal is three eggs and two slices of bacon and a half a piece right? What happens then?

Ed Damiano 59:59
Great question. So as I said, with a meal announcement, all we're asking you to do is be what we call carb aware, meaning, you know, know what the difference is between the three macronutrients know what a fat a protein and carbohydrate are, right? You should that's every every, every person should know that whether you have diabetes or not everybody should have that level of nutritional education. So with the eyelet, we expect that level of nutrition education, and we provide educational materials in our training documents to help understand some of the macro nutrition, some basic nutritional guidelines, but essentially, understanding that, you know, if you're eating eating eggs and bacon for your, for your breakfast, and you're having no carbohydrate, there's no meal announcement to be had, it doesn't matter if there's 80 calories on that plate, right, or, you know, whatever your hundreds of calories on that plate, you know, 150 300 500 calories, if there's no carbohydrate, and there's no need for a meal announcement, suppose you're a grazer, and you never have more than, you know what we typically say, for adults, if you're having fewer carbs than just a single slice of bread, then there's no need to meal it out. So that's just a rule of thumb. Again, you'd like to stay with numbers. But for an adult, you might think of, you know, a piece of bread, or anything less than that, you can probably just skip the meal announcement and let the corrections algorithm do the rest. So for small snacks or meals, where you have very low carbohydrate, you wouldn't meal an ounce. Where would

Scott Benner 1:01:17
I expect my blood sugar to go in a scenario like that?

Ed Damiano 1:01:21
Oh, well, I mean, it of course, it varies. But I mean, if you had a very low carbohydrate meal, you know, you could see an excursion, you could see a small excursion to you know, 100 to 200. Meg's per deciliter, and the direction album could kick in, and then bring you back down. If you had a very high carb meal, like suppose you had, you know, 120 grams of carbs, right. If you're a teenager having a big bowl of cereal cereal in the morning, it's not an unreasonable to see her glucose, go to 250 or 300, even with a meal announcement, because it takes time because we do encourage people to do it at the side of the meal, but not before. And by the way, if you forget the meal announcement, and it's been more than 30 minutes, since you started the meal, we asked you not to do a meal announcement, then just let it go, let the corrections do it. But it isn't unreasonable for your glucose to go to 250 or 300. If you have a very large carbohydrate load, even with a meal announcement, but then the correction will kick in and take care of that.

Scott Benner 1:02:17
And I couldn't say have a breakfast that I called normal and then realize like, oh, hell, it was larger than Can I go back and tell it like, hey, you know what that was a large breakfast, or do I

Ed Damiano 1:02:29
know what you would do is the way you would try and deal with that is suppose you have a breakfast, and then you want to have or dinner and a dessert, right or a meal, let's just get it out of the category breakfast is, in general, if you have a meal, and you look at what's in front of you now estimate is this usual, more or less than usual for me. And so in what's in front of you, now, I'm going to clean my plate, I estimate I estimate, I'll clean my plate, let's do usual for me and swipe. And then it'll give that that meal dose and it'll start watching your blood sugar rise. Now let's say 45 minutes later, you're gonna have a dessert and dessert comes and it's got more carbs than the meal. Then you could add right at that moment, you could say more than usual as another because it's like another meal and you can just stack it right on, attach it to that it's not stacking, because you really do need that insulin. So you're attaching an one meal announcement to another and they're separated by say 30 or 45 minutes, whatever it is between the time you get your primary meal, and you get your dessert. So desserts can very often be more than usual. Because they very often are carb rich. So you shouldn't resist you'd still call it so let's say you're having a dinner and you have a usual for me dinner, typical amount of carbs and then the dessert comes in. It's it's you know 50% or 75% more than your carbs and you'd have in there in the in the dinner you just you just swiped for you then swipe for a more than usual dinner as your as your dessert.

Scott Benner 1:03:49
Okay. I'm going to look through a couple of these. These. These questions here? Sure. Do you have an idea of what it would cost out of pocket? Once it's available?

Ed Damiano 1:04:01
Out of Pocket? Are you do you mean with insurance?

Scott Benner 1:04:04
Now if I didn't have insurance, I want to pay cash? Oh, yeah. Do you have? Yeah, I

Ed Damiano 1:04:07
do think yes, you can. You can buy you can buy. We have one of our distributors that allows you to buy direct if you were to do a cash pay. Okay. So yeah, I think it's very, very similar to the price you might pay for an insolent a durable insulin pump. So, you know, several $1,000 is what you'd expect to pay for out of pocket cash pay. And you would purchase that not directly from beta, but one of our, like eight or 10 distributors that we're working with. There'll be one distributor you'd go to to do a cash pay, and there's a special price for that. And you can if you'd like if you're in a warranty and you want to get out, you can do a cash pay. Again, it's important now we do have the 90 day return policy and that's important for people to find out if they can live well with the eyelid or if it's not the right device for them, and it's

Scott Benner 1:04:54
covered by a wide range of of insurances. It is how What kind of uh, hell is that setting up on the business side, people that go out and knock on an insurance company doors and I mean,

Ed Damiano 1:05:05
it's dedicated team, right? First of all, we have a dedicated team and market access team at beta for helping people with reimbursement. But the way we started this is through the what's called the DME channel, the Durable Medical Equipment channel, right. And through the DME channels, you have distributors across the country, and each distributor has set up contracts with all the commercial payers, so they had that there, like a buffer for us. So they'd had all those conversations. And similarly, CMS can go through those distributors as well, once we have our contract our contract with CMS setup. So we will sell through distributors at launch, we do also, we're very interested in getting into the pharmacy channels as well, which we think is in our future. And we have several reasons why we think that makes a lot of sense. And it's best for people with diabetes as well as as providers. But for now, and at launch. It's all through the DMA channel,

Scott Benner 1:05:54
okay. Infusion sets, just what are their options,

Ed Damiano 1:05:59
we have one steel set at launch and one Teflon set, they're both 90 degree six millimeter, and they're made by unit medical. So we are using the unit medical family of infusion sets. So if you're familiar with the terminology, we have the inset one, which is six millimeter 23 inch tubing to the eyelet cartridge, and we have the contact detach, let's put this Teflon set and the contact details for the steel set, which is a 90 degree. You know, I think it's a six millimeter 29 gauge steel set.

Scott Benner 1:06:31
So you said something earlier that it's not leaving my head. So I'm after asked about it. If I sit down at a burger joint, and I have a cheeseburger and french fries. And I go okay, the rolls 30. And I'll even throw in five more for the burger just in case and the fries are 80 carbs. So it's 120 carbs. But I know for certain that 90 minutes from now when my digestion slows down and that fat slows everything down. I'm gonna see a rise up to 220. If I don't Bolus for the fat, how does it deal with that?

Ed Damiano 1:07:04
Right? So you're you're you're invoking this idea of a square wave Bolus or something where it's been a very complicated way, with a traditional pump, you think about saying, well, let's release some of the insulin now. And then later, I want more insulin to come in a second wave. gastric emptying happens over a long period of time, right? Because of the fat and the protein slowing that? Well remember what I said at the beginning, we have two other algorithms besides the meal announcement algorithm that are running every five minutes of every day. It's like a perpetual squarewave Bolus ready to be let loose, if needed, but only if needed. Okay, so it's watching you every five minutes. And suppose what happens is the meal announcement comes in, and some of the carbs are released quickly. And you see this rise in the meal announcement insolence catches up to it, and you start coming down and you dropped to say 170. And now you're at like two hours out, and you're down to 120. And suddenly you start to rise. The Basal control is just chugging away. The Corrections Adams watching it, it's like a hawk every five minutes now suddenly start drifting up to 151 6170. It starts adding insulin saying basil, you're not you This is out of your league. I'm coming in to take over and so the correction element comes in and starts adding insulin without you having to pay attention any of that because it's not your it shouldn't be your job to do that. Is that is that

Scott Benner 1:08:19
stream thinking?

Ed Damiano 1:08:21
They just ate three hours ago. This is probably a reoccurrence or does it not care. It has no opinions. It just it sees no judgments and no opinions. A number and it goes no, no, no. Yeah. All it cares about is your glucose at the moment. And it uses gets past insulin insulin history with you it's learnings from that history and your current glucose level and the amount of insulin that it is that is pending. It's keeping track of all the insulin that's pending every five minutes and updating that itself.

Scott Benner 1:08:48
So if Bolus is the number it sees not a predictive trend, it's not.

Ed Damiano 1:08:54
Yeah, I mean, it's certainly we have we use something called Model Predictive Control. So it does look, it does make an estimate of what the glucose is going to be in five minutes from now the next step, and then it will update its estimate of that at the next step once it sees the real value and compares it to the model. But that's it, it's just a, it's a five minute prediction on what your glucose is going to be. But importantly, it keeps track of the very long horizon into the future of your insulin tail. Because every dose it gives, it keeps track of how long that dose takes to rise and picking your blood which is usually about an hour and six more hours before that insulin I'm giving right now is really got mostly gone. And then five minutes later gives another dose and it's superimposes that insulin rise and fall profile and it has that insulin to look forward to it's what we call pending insulin action. It's accounting for that and predicting what your glucose is going to be in the next five minutes

Scott Benner 1:09:45
when I talked to people in in person when I do in person talks I explained to them about there's different levels of or different lines of insulin happening all the time you put in some here the Basal is hitting peaking and tailing. And then the basil from five minutes later is hit, you can't keep it all straight in your head, right, but so is every Bolus. And if you if you really think about it like that there's, there's these constant pushes. It's right fantastic that an algorithm can like, make quick sense of that.

Ed Damiano 1:10:15
And that's what it's, that's all it does, like, you know, it's really good at this very narrow task, it's much better than we are the vast majority of we write it is much better than that, because it's got one very narrow job, we do many things very, very well. But the vast majority of us can't do what the eyelet can do, because it's its only job, and it's doing it every five minutes, it doesn't have anything to distract it. That's all it really cares about. And so it keeps track of every one of those doses and literally superimposes those doses, one on top of the other to account for how much insulin is trailing off and how much is rising.

Scott Benner 1:10:48
It's got a cartridge, right? And for how much does it hold?

Ed Damiano 1:10:52
It's 180 unit cartridge. And after you prime the tubing, you'll have about 160 units. So we found it lasted about three days in the average adult,

Scott Benner 1:11:02
okay, but if I pop I just get somebody to write me a script for more and so it's I've never right, I'm gonna I'm gonna sound odd for a second. I've never, I've never used the tube pump. So my daughter Okay, and using exclusively Omni pod since she was four. But you just pop out that cartridge, put a new one in prime it and keep going.

Ed Damiano 1:11:19
Correct. So let me tell you two things about that cartridge. One is we have we have two different types of cartridge. One is a patient fillable cartridge. So it's a glass cartridge, 1.8 ML, and you can put human law or Nova log in it through the septum, you just draw it out of a vial like you would with your Omnipod into a syringe and then introduce the syringe needle into the septum of the cartridge which looks just like the septum on your insulin vial. Yeah, and then you introduce the insulin and remove the bubbles and then you load the filled cartridge into the eyelid chamber, quarter turn to have the eyelid connector and tubing to the eyelet. And then it'll prime some of the tubing and then you prime the rest of it and hook it up to your set. The other thing I want to tell you about is that in the pivotal trial, we used human logon Nova log in the adults in the in the randomized control trial. But we also had a cohort of adults use fiasco in a prefilled cartridge that no one artist makes which is identical in shape and size to our patient filled cartridge, or ready to fill cartridge and it's filled in a blister pack, it comes in a blister pack of five cartridges and it's prefilled with the Aspen so that dispenses with the need to transfer insulin from a vial and pull up the air bubble. And that process takes about five minutes or so we eliminate that. So with the prefilled cartridge in the trial, you just pop it out of the blister package, slide it into the chamber quarter turn and you prime the tubing, you can change a cartridge soup to nuts a prefilled cartridge vs cartridge in less than 60 seconds with the out because it's got a very fast motor drive train like the atom is pumped it for those of your listeners who are familiar with that. So we had it we emulate that very fast movement of the rewind and then advancing and priming you can do less than a 62nd change if it's a prefilled cartridge,

Scott Benner 1:13:02
did you notice any better outcomes with fiasco or other insolence?

Ed Damiano 1:13:08
Not much for one thing I'll say is that in almost every every analysis we did it was very similar to human login or login the adults 18 and older. And what we found was that in every way, you know, it had very low levels of hyperglycemia. Like similar to standard of care, like we saw with hemoglobin Novolog. It's mean glucose was very similar. The ANC was similar time and range was similar 71% With vs versus 69% in the adults for hemoglobin Novolog. But we did see a statistically significant improvement in time and range. It improved by 14% relative standard of care relative to human lung Novolog, islet users which saw an 11% improvement in time and range. So that was statistically similar, but it's not sure I'm not sure that's clinically relevant. But it was a little better. And one thing I add to that we didn't tell the islet it was fiasco. Right so we have hard coded in the islet knowledge about insulin kinetics. Now we know that the aspirin the aggregate absorbed more quickly, in most adults, or you know, in the aggregate of a cohort of adults, then he will log on over log and it clears a little faster. So it's a slightly faster drug. And if that information had been provided to the eyelet, we have some pre pivotal studies that showed you might see better glucose control and lower mean glucose higher time and range with the aspirin human log, no log. But we for this study, we talked to the FDA about it. We didn't have enough data to do go into a pivotal trial and adjust the the built in parameters in the device to let it know that fiasco was faster. So it was under the assumption it worked operate under the assumption that it was just like chemo Novolog. And so it didn't get to leverage the faster kinetics. It was in the mathematics that's built into the device in the future. We will visit that possibility. But we didn't see big differences and probably just because we couldn't tell it it was faster Okay.

Scott Benner 1:15:00
If should people hear that those are the only insulins they can use and think that that's the case? Or can they use the I mean, you can't tell them to use it off label, but it's something horrible gonna happen if they put a pager in it or something like that as

Ed Damiano 1:15:14
well, we didn't test it with Piedra, we did test it in adults with jemalloc. No bloggin. fiasco. And one thing I didn't mention is that is that the when people who randomized to the standard of care arm in the pivotal trial for 13 weeks, they kind of drew the short straw. I mean, they want it to be in the trial to test the island, but they ended up randomizing to their own care. So what we did was, those people had the option who randomized Sustainer, care to spend 13 weeks on the island after the study ended. So they could cross over the island. And the vast majority of them did just that. And when the kids crossed over, they all use the Aspen the prefilled cartridge. And we saw very similar results to what we saw with the adults with the ASP. So what we have right now in front of the FDA is an application to get the prefilled vs cartridge approved for use with the eyelet. And that's going through the process right now. So we're hopeful, hopeful that that will that will come through soon. But right and at launch, it's cleared for use of human lot with hemoglobin Oplog in our patient field cartridge,

Scott Benner 1:16:10
right? A couple of ideas around you being a smaller company. So people ask questions, like, you know, there's the diehard on the pod people that are like, Look, if it's got tubing, I don't want it, can they make one without tubing? Can they get it for kids under six? Can they can they can they do you have the bandwidth? Can they can they can they or where are

Ed Damiano 1:16:29
you at? Yeah, I mean, we do have limited bandwidth. But we're very creative about some of the things we can do. Like for instance, because we came from an academic realm, myself and Stephen Russell in, you know, in the early days of the project, we do try and think creatively about ways to bring resources, financial resources into the company to help us do trials that might give us indications for use for other kinds of conditions, right, other kinds of diabetes, you know, and so forth. And different age groups and things like that. So what we have done is we've worked with other investigators who are in academia, like ourselves, and they can put in grant proposals to the Helmsley Charitable Trust the JDRF, the National Institutes of Health, to get funding for studies now dilates, FDA cleared to test it in other indications. And so our hope is that we can work collaboratively with academic institutions and clinical investigators like ourselves to do those studies, instead of it being Stephen and Ed's teams doing those trials, we're now going to work with other investigators like ourselves, to do that in the academic realm. So we can leverage all that financial resource that comes from private foundations and government funding, it doesn't come money that's coming to beta, but then beta doesn't have to spend the money to do those trials. So that's how we hope to get expanded indications. And at this time, at least, and then, you know, as the company gets more resource, then maybe we could do some, some sponsored studies as well. But we're limited in what we can do. Outside of you know, we really want to get the buyer model pivotal trial started, because we're very committed to bringing the buyer model eyelet. Yeah. To people with title,

Scott Benner 1:18:00
I want to get to that. I just, I have a couple more questions first, of course. So I don't know anything about what you did, like, I don't have technical knowledge, did you decide we're gonna shoot for a seven a one C? Or is that what the algorithm is capable of? Like? Were there four dials? You could have turned and you'd be on here telling me oh, it keeps people around to 681. C, and you spike to about 180? Not to like you don't I mean, like, or is that not the case?

Ed Damiano 1:18:26
Yeah. So the way we did this is we started by studying the by hormonal system. And we we chose a glucose target, and aggressiveness factors and things like that initially. And then and we did these studies, first in the inpatient Center at MGH, just with the by hormonal system, once we started human trials, and after a while, we, you know, it became clear to us that with the biochemical system, occasionally the glucagon channel might be might not be available. And so what happens if the glucagon runs out while you're out and about, well, what happens if you have an occlusion or your Google infusion set fails, then if that happens, you know, it needs to sort of fall back safely into an insulin, a single hormone insulin only configuration, and we hadn't really tested what that looks like we weren't back then thinking about making a single hormone islet is a product, right? We were thinking about this being a fallback. And so we started doing studies testing the by hormonal, bionic pancreas against the single hormone bionic pancreas against standard of care. And what we found was the single hormone Bender packers was a very differentiated technology in its own right. It couldn't it but it had had had all of its glucose targets had to go up higher, to be able to get really good glucose control and not have hyperglycemia. And so we started studying different glucose set points for the insulin only system and for the by hormonal system. And with single hormone, we found that you can safely have these targets up here and not have much hypoglycemia. And with the by hormonal ones, we could have safely have these targets down here and still not have hyperglycemia. Because glucagon is helping that. So we could basically have effectively something that could give a little bit more Just went up front a little bit more aggressively, just because the targets are lower that it operates under with the buyer model. And so that's how we came to figuring out what these targets were. So the agency that it gets, or the media glucose that it achieves was really It fell out of the mix, we weren't shooting for a particular target of is it going to be to get 154? We said, What is this system do configured this way with this target? What is the average or cohort will get on the system. And we found out with the single hormone, it was about 155 In adults, and the bimodal and in adults was more like 140. So it's about 15 meg per deciliter improvement by adding the second hormone and being able to use these lower targets with single hormone. As you lower the target every time you lower the target, you see a lowering in the mean glucose but a concomitant increase in time below 54. With the buying hormonal system, we saw as you lowered the target, you saw a progressive improvement or lowering of mean glucose without an increase in hyperglycemia. But with an increase in glucagon usage, okay. So we exchanged hypoglycemia for slightly increased and glucagon infusion. And so we can keep these lower targets safely.

Scott Benner 1:21:11
So when you get to a dual chamber at some point, and you're doing glucagon and insulin, what do you think you'll be back on here telling people about their outcomes?

Ed Damiano 1:21:20
Oh, so what we've seen in the as I mentioned, what we've seen in all of our pre pivotal studies that we published across over the years is a mean glucose. This is about about 15. Meg's per deciliter lower than what we saw with the eyelet pivotal trial, which would correspond to about a half a percent lower a one C one. And as as you may recall, I said about about almost half the people had a mean glucose below and 54. On the single hormone island of the adults, what we see is that about 90% of people on the buy hormonal system have a main glucose below and 50 for adults. So it's a big difference in terms of bringing more people under,

Scott Benner 1:21:58
and it's going to become increasingly unlikely that you experience a low and what are we calling a low, by the way, you said it arranged a couple times is that 71 8070 to 180? is what we're calling in range. Okay. And so that's timing, right? The lowest 69?

Ed Damiano 1:22:13
Oh, no, no. So yes, certainly. That's, that's out of range. So that's below range, right? So we measure two different we keep track of two metrics. In our pivotal trial studies, we had an outcome that looked at how much what percentage of time do you spend 70? And what percentage of time you spent below 54. And the way we powered the study was we said that, you know, we powered the study for statistically for superiority, we expected to see a superior outcome in HBA win see in reduction of HBO and see so we saw a superior we thought we'd have superiority in a one zero standard care, and non inferiority in time below 54. relative standard care. And that's exactly what we found in the trial. Yeah, I feel

Scott Benner 1:22:52
like I haven't, like just expressed enough how pretty amazing it is just the meal announcement portion of it. Like I can't imagine what a what a relief that must be to people. Did you talk to them about that in like exit surveys and

Ed Damiano 1:23:09
things we did? Excellent question. So we had we had focus groups at the end of the trial. So we worked with Joe Weisberg, ventral she's up in Chicago, and she works at the Lurie Children's Hospital. And so she's an expert in psychosocial and behavioral outcomes when it comes to studying diabetes technologies. So she developed, validated, behavioral psychosocial tests questionnaires that we gave throughout the study. And also ran the focus groups at the end for people as they came off the device. So that was qualitative. So we have these quantitative questionnaires. And then we have these qualitative focus groups at the end. So we did get to find out, you know, how people felt about things like diabetes, distress, fear of hyperglycemia, but also just sort of qualitative measures of how how people feel about the eyelet. And I do think you're right about this giving up of carbohydrate counting this diabetes without numbers is really important to people because we're trying to say that we really hope this device is agnostic to levels of literacy and numeracy to levels of to technical acumen to socioeconomic status, race, ethnicity, and so we did a lot of work. In the trial doing subgroup analysis, we published something in the European Journal of Medicine after the main study was published, in a letter to the editor looking at the subgroup analyses to show that the people who needed the most improvement in glucose got it from the eyelet, more so than people who were very close to range. And so it didn't seem to discriminate against people if you're an MDI therapy and never use the pump versus people aren't hybrid closed loop didn't discriminate against people who had never used the CGM versus those who had. What you do see is the people of the highest baseline agencies at at baseline before the study started. So the greatest improvement and you'd mentioned, you know, I imagine you're seeing people with higher agencies than other studies, our highest day when he was 14.9 at baseline, so we brought people in across the mix with you know, hi, when season the double digits

Scott Benner 1:25:04
did that 14 leave at a seven

Ed Damiano 1:25:07
6.80. Wow. So the 14.9 went to 6.8. That is not. That's anecdotal though. That's one data. We had. We had other people at agencies, you know, maybe have nine that dropped eight and a quarter and a half or something like that. So it's not everybody sees that remarkable reduction. But it is noteworthy that some do. Yeah. And again, it's a device with you know, that you initialize with bodyweight and you use meal announcements without counting carbohydrates.

Scott Benner 1:25:33
It's a very small barrier to entry. That's for sure. And I mean, obviously, you're talking about, like data that's at the end, this is the average, but not everybody achieved a seven. But that's still just worth bringing up that there's a 14 that came down that Fars is insane. Yeah. Do you think you'll get in other countries in any time soon? Or is the US? Yeah,

Ed Damiano 1:25:54
I think that it's quite surprising how things have changed through the pandemic. So it used to be that med tech companies would first target Europe, as you probably know, in diabetes, med tech was no no exception to that, where they would start in Europe, they'd get what's called a CE mark, and they'd start distributing in Europe. And then they would work their way into the US with a big pivotal trial, and then they get FDA clearance. We're doing it the other way around. So we got FDA clearance first launched in the US first, the next step for us to come to Europe or other countries owe us will be a CE Mark, what's happened through the pandemic is the CE CE mark process has really changed, it's much longer process it's taking, it's taking a very long time to get regulatory clearance outside of the US now it used to be quite the opposite. So it's certainly something we're going to pursue our goal at beta bionics is to bring this technology to as many people as possible, because it is a device that's made for as many people as possible is literally designed for that, that that kind of uptake in that kind of broad demographic adoption. So we certainly want to get this out to Oh, you owe us to Europe, Middle East, in other countries, other regions. And that will require first to CE mark. So unfortunately, that will take a long time just from a regulatory process. It's certainly more than a year's worth of regulatory review, right? But it's certainly something we're going to be doing.

Scott Benner 1:27:14
I have a fair amount of Canadian listeners that will be mad if I don't just say Canada like out loud. Of

Ed Damiano 1:27:19
course in front, you have to say Canada. Yeah, I mean, they are literally our next door neighbor. So we've got to Canada and Mexico, we've got to get out there right and you mighty mark is the way to start. He

Scott Benner 1:27:27
shouldn't have let all that smoke come down and choke me out or I would have been a little more. A little more feeling about it. Okay, so like I told you before we started recording when I first heard about this, I thought, oh my gosh, this is amazing, right? Like they're gonna have glucagon in the same pump. And you know, it's going to stop you from getting low. I have a couple of quotes. And I'm assuming the the major hold up was liquid stable glucagon, it had to had to exist in the pump for the amount of time at least you were wearing it. So now that exists. And you have access to that great. Does this my first like Boohoo? Like I don't know. Like question is, is glucagon doesn't work if you're drunk. Is that right?

Ed Damiano 1:28:10
No, that isn't right. So we had, we had looked into that specifically. So Stephen Russell did a clinical trial where he actually brought people into the clinical research center at MGH and got him drunk IV though. So we actually got a protocol approved and what he did was he we can infuse alcohol intravenously, and look at the efficacy of glucagon. Okay, Mike would that is microdose not big rescue doses, right? We're giving tiny, tiny doses of glucagon. Okay, I see. All right, and it's not Basal glucagon. It's not like every five minutes, you're gonna get a dose of glucagon. It uses glucagon sparingly and only as needed. But the dose you might get at any step where it sees your blood sugar might be your glucose CGM glucose might be dropping, or if you're already low, that dose could be one to 2% the size of a rescue dose that small, tiny little doses and he gave us doses that were comparable to this to the to the doses we would give in the in the bionic pancreas, the by hormonal bionic pancreas, and at different levels of blood, blood alcohol levels in the in the Clinical Research Center. And he was able to see that there it was, it was pretty much insensitive to the levels, alcohol levels you'd likely see out in the wild. So let's put it that way.

Scott Benner 1:29:20
So a rescue dose of glucagon might be different in that scenario, but the small amounts you were using were working.

Ed Damiano 1:29:26
Yeah, so he didn't test the rescue doses to see if that would be an issue. But definitely that because you know, the doses we're giving are so small, you're not depleting glycogen stores because what glucagon does is it breaks down stored glycogen in the liver, which is a stored form of glucose breaks it down and it liberates glucose into the blood and that's how it raises your blood sugar.

Scott Benner 1:29:43
I I'm asking this question way too ahead of but now we're into it already. So would do you foresee the eyelet being able to rescue if you're not drunk in a rescue situation like if it if it somehow thought this person's going to zero? Would it go for it? or would it?

Ed Damiano 1:30:01
Yeah, it wouldn't release the whole cartridge if that's what you mean, right? It wouldn't do that. And by the way, the amount of glucagon in this little tiny glucagon cartridge is much more than what you'd see in a rescue dose as well. It's a small cartridge, it's only it's only one ml. So it's like, think of a cartridge only 100 units of insulin. That's the size of this cartridge. It's really tiny. But the glucagon we're using made by Zealand Pharma is four times more concentrated and rescue glucagon, okay, it's four Meg's per ml versus one meg Parral ml. So you wouldn't want to ever unload that whole thing. It's really about a seven day supply of glucagon further, by the way, the islet uses it lasts about a week and that little cartridge, but what it would do is it wouldn't wouldn't actually give a rescue dose. But it would continue to give glucagon doses every five minutes if it doesn't see your glucose coming back up. And remember, it also turns insulin off just like the single hormone islet does. Yeah. So it's using both it's using the X gas and accelerator, I like to use that analogy of the insulin is like the gas and the and the brake is the I shouldn't say gassing sorry, should it break an accelerator. The insulin is like the accelerator and the glue guns like the brake. And so you really want to take your foot off the accelerator and hit the brake, if you want to slow down quickly. And with the single the biometric system, you have both at your disposal. Okay. So hopefully, you know, the amount of glucagon that it can give should really prevent any need for rescue glucagon, as long as it's flowing into your, under the skin.

Scott Benner 1:31:22
Is there an amount of time or a number of like, little bumps with glucagon before? Like, doesn't it eventually, like just empty your liver? And then there's just no more there anymore? Right? Yeah. And you're

Ed Damiano 1:31:33
not going to get to a point with environmental system where you get depleted unless you were very sick, right? So suppose you've been you had a vomiting illness and you haven't been getting, getting anything down for a few days, you could get into a situation where you're depleted of glycogen stores, and then there's no substrate upon which glucagon can act if there's no glycogen stores. But that's,

Scott Benner 1:31:53
it's hard to get to that stage. I was gonna say, and in that scenario, doesn't matter how you're managing, you'd probably be in the hospital one way,

Ed Damiano 1:31:58
I think you're going to be finding your way into the hospital in that situation. But what we did see in our, in our pre pivotal studies is that you're, you know, overnight, where you're getting just Basal insulin overnight, so you're not having a ton of insulin, which helps store glycogen. And you're not eating at all, and you've been fasted for a very long time. So you got no carbohydrates for seven or eight or 10 or 12 hours, right? Since you went to school, since you had your dinner went to sleep. When they got up at the morning in the morning at 7am. And they start becoming active and there, they there might start going low, you'd see these little shots of glucagon, tiny little micro doses at 6am and 7am. And it would pop them up. So that meant that even though they've been fasted for 12 hours, they hadn't eaten anything, and they've been getting very low levels of insulin, they still had plenty of glycogen upon which that glucagon could act, okay. And so we never saw any depletion of glycogen storage, any any evidence of that in any of the trials we did, and sort of routine day to day basis, but we've never studied, you know, pushing it to the limit to see how many days could you go fasting, before you'd run out of storage? I don't know.

Scott Benner 1:33:00
I just imagine that most people I try hard. But I imagine most people think that rescue glucagon is like sugar that brings up your blood sugar, and they don't recognize that it actually signals your liver, you know, etc, and so on. Like, I don't know how well that's understood.

Ed Damiano 1:33:16
I mean, if it were up to me, I would if it worked, which it wouldn't, I would rather push sugar than glucagon because it doesn't have to rely on that secondary source of sugar. Yeah, liver that could be depleted when you're sick. But there's no way to infuse tiny amounts of sugar under the skin and have it do anything, it's we really we do use the hormone just the way the pancreas does. That's how the Packers prevents hyperglycemia your first line of defense, people without type one, their first line of defense against hyperglycemia is glucagon. And it's it's, you know, we should not have the hubris to think that we can build a truly biomimetic closed loop system without adding glucagon back because people with type one diabetes lose their ability to use glucagon effectively. So when the when the autoimmune attack takes out the beta cells that secrete insulin, it disrupts the alpha cells ability to release glucagon, they still make look and they just don't release it in any coordinated and useful way anymore. So they really have a dual hormone insufficiency. And that should never be ignored. And so that's one of the things we do with beta bionics is not ignore that, right, we build an entire technology platform that will look just like this one, right? It won't be any bigger. It'll have, you know, we have we built a second chamber here to take a glucagon chamber. And this is actually the exact same platform that we'll be we'll be testing in the pivotal trial with two hormones system,

Scott Benner 1:34:30
when is that going to happen?

Ed Damiano 1:34:32
So our goal is to have that start by the end of the year. 2023. Yeah, so we want to have that trial start by the end of the year. Now that's that's that trial is is huge. So as I mentioned, the single hormone study the biochemical pivotal trial, the bionic pancreas, overdrive with a single hormone device was the largest automated insulin delivery randomized controlled trial ever done. Right. by a longshot. The by hormonal pivotal trial will be way larger, in fact, eight times larger in terms of the number of Patient years of exposure. So it won't be a three month trial, it'll be a 12 month trial, it won't involve 440 people. it'll involve over 700 people. And we're going to have phases. So if we start by the end of this year, the first phase will be a small cohort of 70 or so people. And they'll engage in a crossover trial with the final buy hormonal device, and the single hormone device that you see here. And people will use both and a crossover design. So they'll spend like four to six weeks in the in the single hormone, Iowa and four to six weeks in the biomedical crossover in random order. Once that study is done, that'll take about six months or so we read out the data. And if everything looks good, and we like the way the system is performing, we lock in and we start the big one year randomized trial. And a one year trial doesn't take one year to do. Because we have 700 people and 30 clinical sites, we have 16 sites and the other trial 30 sites or so it takes a half a year just to load everybody into the trial 700 people and then a year for the last person in to finish, that's an 18 month commitment. So it's a long road, right? It's going to be a couple of years, two and a half years just to get to the last participant last visit of the buyer model trial. And then you have to build the FDA package, submit that and they have to review not just the by hormonal island. But here's the big sort of the long pole in the tent, they also have to review the glucagon glucans never been used chronically, it's only used as a rescue. And so Zealand pharma will have to put in their own application for dasi, glucagon, as they call it, their analog of human glucagon, which is a, you know, a 12 month typically a 12 month review process with the FDA that will go in parallel with our buyer model Island.

Scott Benner 1:36:34
Did they have to wait for this first eyelid to be approved to do that? No, it's just no time? No,

Ed Damiano 1:36:40
no, it's just that we were just, you know, we couldn't do too many things at once.

Scott Benner 1:36:44
Is there anything about any patents you hold that would stop an insulin pump company from going to a duel hormone? Or?

Ed Damiano 1:36:52
You know, we have we have intellectual property portfolio that I think is pretty robust, not just in terms of the by hormonal, but also the single hormone algorithms. So yeah, I think that our on our algorithms side, we have some IP out there on bio hormonal, that's pretty robust. But ultimately, you know, we're not engaging in an exclusive relationship with sealant Pharma. So if somebody wanted to build a dual chamber system, you know, they'd have to sort of work around our IP and build their own algorithms. And they'd have to work with Zeeland pharma to figure out how they're going to use their drug. But it is true that if we do the pivotal trial with the Zealand pharma forming per ml concentration drug, that particular very specific formulation and get FDA approval of that any other pump company that builds a dual chamber system would not have to do as long a study with the Zealand pharma for a per ml formulation, right? Because it's been proven out to work in chronic use this way. So is this going to be two different infusion sets? Well, in the trial, it will be but ultimately, that's not our intent for the commercial product. So we can start the trial and do the pivotal trial with two separate sets. And all of our pre pivotal psychology studies use two separate sets. And they're both unit medical infusion sets one was an insulin and one was a glucagon and we put them right next to each other, they're about a centimeter apart. What will will ultimately want to do is build a single set that has, you know, a couple of cannula in it, you'd insert that and one go every like three days or so. But you will have two separate tubes that you could sort of tie together like speaker wire here like at the headphone jack wire. And the reason it's important that you have the two separate tubes is because the insulin cartridge might last three days on average, and the average adult say and the glucagon cartridge might last a week, they're not going to be changed on the same frequency. There's no reason to change them both out if one is still has a few days left in the cartridge. Oh, that

Scott Benner 1:38:40
makes sense. Yeah, I was just trying to like, like I always have, people always ask me for years. When is they always say they when are they going to put them on one device? And like, I don't know what you're thinking about like you want like a CGM and a pump in the same like structure, which I'm like, That can't happen like forget business. Like Like, like functionally it can happen. Right? Well,

Ed Damiano 1:39:04
the thing about it is that with Transcutaneous, CGM sensors, right, they typically are lasting 10 to 14 days, right. And we now have infusion sets out there that are FDA approved to be used for up to seven days. But they don't, on average, last seven days, that's what they can be used up to. But on average, they last shorter than that. Well, why is that? Well, mainly what fails with infusion sets very often as the adhesive fails. And you know, when you are infusing liquid you know insulin under the skin, that he's if you're and you have a tube that's connected to it as you move around that tube is putting a little bit of stress on the infusion set all day long every time you twist and turn and it's tugging on that set. And so the adhesive ultimately is overwhelmed. And after three four days, some people can run it out longer but other people can't and it depends on the to how the adhesive works with your skin and so forth. But generally Do you want someone who uses an infusion set for four or five days, we'll start to see if they go well beyond its intended use, we'll start to see the set fail. And what happens is the insulin starts flowing up around the cannula and wets the skin and doesn't go into the body. Yeah, but, but if you look at a sensor, you put a sensor in, and it's not nearly as much stress and pulling on it, there's nothing connected to it, right your shirt to touches it, but you're not pulling on it with a tube every now and again. And that adhesive can really last longer, and it's more forgiving the sensor under the skin, if it moves a little bit around relative to the tissue versus a cannula where insulin can then leak out. So they just they have very inherently different life's life scale, lifetime, you know, or characteristic time. So make and stay under the skin.

Scott Benner 1:40:42
I wish people could have seen you because I enjoyed watching the the engineer and you know, like, like the face up. Because I always think that when I always think like simple things, like, first of all, what do you like, you're gonna build us like, on the PA that has a Dexcom in it like that, how's that gonna happen? And what happens if your sensor goes bad in three days, but your pumps work or two days, but your pumps working for like, you want to rip the whole thing off? Okay, you understand the desire. But it's always I always feel like that question is asked by somebody who's never built anything before in their whole life. And, you know, yeah,

Ed Damiano 1:41:13
there's just inherently different sort of lifelines, or whatever you would say that sort of the lifetime expectancy of those two systems are so inherently different, and you don't want them to be coupled. Because you as you just said, you don't want to have to change all three, because only one fail right

Scott Benner 1:41:29
right now. Okay. All right. So I've had you for a long time longer than I promised. I have one question. And then I'm going to ask you, if there's anything we haven't talked about, a number of people asked me, islet how like, you know, 40 carbs of I don't know, a soft pretzel, and 40 carbs of cotton candy, 40 and 40. But significantly different impacts, it doesn't matter to the

Ed Damiano 1:41:54
eyelet. No, it really doesn't. Because as I mentioned before, it's because the corrections algorithm is always running in the background. So suppose you have what you're really getting at, I think is a food that's got a very high glycemic index versus one that's got a very low glycemic index and takes longer to raise your blood sugar. Or it's just more muted, right, you just don't grow up as much. It's just it's just, it's just extended out to over a longer period of time. So the island is watching every five minutes. And it has unlike, you know, most hybrid close up systems, it has the occasion, or the opportunity to dose every five minutes if it needs to, so it's always on top of it. So if you have something if you do the meal announcement for that 40 grams of cotton candy, you're gonna see a very fast rise. And the meal announcements going to kick in. And the the it's going to keep track, the islet keeps track of the insulin in that meal announcement dose that it just gave, and it watches the glucose rise, and it says, Okay, if you've got all this insulin pending, I'm keeping track of its rise and its clearance and I'm watching your glucose rise. Now if you rise very quickly, it might just stay in the background for a while there will come a point where I'll say I'm gonna add a little bit more correction insulin now because the correction algorithm has been quiet. But now I think you've risen high enough that the meal announcement insulin even insulates. Pending from that meal announcement isn't enough. So I'm going to add a little bit more, and then it's going to walk it's going to keep watching. And it's very patient because it's keeping track of the insulin it just added, in addition to the meal announcement insulin, and then it'll see it crest if it's a very high glycemic index food, it's just going to rise quickly and and stop and then start coming down. And it'll see it come down, it'll just back off your blood sugar, it could be 252 20. If it sees it slow down, it's going to back off, it doesn't care that you will hyperglycaemic It knows that insulin is coming, it's gonna be patient. And now what if instead, you didn't rise nearly as much, because it's a slow a low glycemic index food. Now you went up to 190 or 220, instead of 250 or 260. And it sees that meal announcements enough, it's really enough, I'm gonna stay back, I'm gonna stay quiet. And now an hour has gone by and you're sort of sit there and now you're, you're coming down to 170. And it's an hour and a half after the meal announcement. But you're still a little bit, you're still a little bit stubborn. And then it's gonna say, well, that meal announcements getting old now. And I'm the correction algorithm checking in every five minutes, I've decided at this step. Finally, that meal announcements not enough given that you're 170, I'm going to start adding a correction insulin now. And so it's very patient and looking at the meal announcement doses and how much your glycemic excursion has risen and how much it's coming. It's responding to that before it weighs in on adding more, but it's always there to add it if it needs to. And it's using very precise mathematics to make that very objective decision. It's it doesn't get it's not irrational, and it doesn't reach Bolus. But it does ask that you the user be patient. And what that usually means is don't keep looking at the iLet and expect magical results and say, oh my god, I'm still 170 Just let it do its thing and that is the ultimately the message that we want to convey to people who use the iOS is let it let it work. Don't Don't fuss over it too much. Just make sure you maintain the character Feeding have it. But let it do its thing and don't try and meddle with it too much. Because you know, it won't help. It doesn't it doesn't get better glucose control, just because you're watching it. And it doesn't get worse glucose control. If you don't watch it. That's another thing we learned from the pivotal trial, you don't have to look at it all the time to get the same equally good control. And you know, with other diabetes therapies, right? We know that the more you interact with a fingerstick meter, the more you interact with your CGM, or an insulin pen, or a pump or hybrid close up system. The the better your glucose control typically is if you look at a group of people interact frequently with their, you know, diabetes therapy, or diagnostic work or another group of people who interact infrequently with it. Those who interact frequently tend to do better statistically, we don't see that with the island, we see that it's pretty agnostic to how much you engage with the device as long as you're taking care of it. And that's, that's a really, I think, a really important point to remember. No, it's a bonus for sure. And the other thing, the other thing I'd like to just was sent heavy. No, go ahead. No, no, I

Scott Benner 1:46:03
was pleased. You're fine. I'm I'm trying to wrap you up. If you want to keep talking. I'm happy for you to keep talking. I just tried to help you out of this.

Ed Damiano 1:46:10
Oh, yeah, very good. I do. I do have a call coming up in a few minutes. But I would say this that what is unique here with the there's a number of things about the AI that I think that are unique, right? It's unique in several ways. But importantly, it determines 100% of every therapeutic dose of insulin. And there's that it's not a system that where you can go and override the dose, you can't add a correction insulin Bolus, you can't add a meal dose, you can't say I didn't give myself enough insulin. So I'm going to add 20 grams of carbs. And it's going to then figure out what to dose which is what a lot of people do in some of these systems. It determines 100% of every therapeutic dose, and you don't override that and your physician doesn't override that. So that is that is not a hybrid system, the hybrid system inherently means that you are playing a role in insulin dosing decision, you and your physician as well as the audit some automation. That is not what's going on here. And as a result of that, you have to really get comfortable with this new world of fully automated insulin dosing decision making, right? That's being added to a device,

Scott Benner 1:47:10
I have to say, I'm actually impressed. And I think it's smart that you're talking about it so directly. Like you're not doing any like marketing, like talking around, you're like, look, this is what it does. If that's good for you, then great. And if not, was nice talking to you. Like I think that's terrific. I don't see enough of that. I've been very impressed with that the entire time you've been going over this. So I really do appreciate, do you think there's anything we didn't talk about that we should have?

Ed Damiano 1:47:38
Not really, I mean, I guess it's more more re emphasizing this idea that the reason I think we can talk so frankly, about is first of all, we want to build technology that's in the best interest of people with type one, we've always been committed to that. And that means that you know, the eyelid, I think is that device that is very complimentary to some of the high tech out there that does serve the interests of the needs of those people who are already in good control, or who have the best had the access to the best resources, the best health care. And, you know, and so we're trying to, to address that other segment, which I think so happens to be the majority of people with type one who don't have all the resources and all the access to the best health care, you realize that you know, 75% of us counties do not have a single endocrinologist in their borders, right. This is something that the Ozeri has published a few years ago. And nightly, whereas 95% of people go counties in the US. So 75% of counties don't even have one endo 95% of counties have at least one primary care physician. Primary care physicians can't use that high tech, it's just it's anathema to them. I mean, they don't have, they don't have the resources, they don't have the staff, they don't have the training, they can't use that tech. But we think the eyelid is a device, a very high tech device that is really the first device that plays very well in primary care, because it is for that large 80% of people who aren't meeting goal. And I do think for those who are meeting goal, many of them will still prefer the island, because they're going to be unburdened of a lot of that cognitive effort and into the vet burden that goes along with constantly being all over your diabetes management all the time. And there'll be others in that same group who just you know, are just too anxious to give that control up. So it's really all about finding those people that that are going to benefit from it and who, who will be able to do that comfortably. And I think he's just a lot of people out there that that we're trying to serve.

Scott Benner 1:49:39
Will you be adding salespeople? I mean, it's because it feels like you're going to have to go to non traditional doctors to talk. Yeah, you know,

Ed Damiano 1:49:48
yeah, we have so we have a very small group at start. And so we've got about 16 people on the sales team right now who are focused in those eight territories I was telling you about and what what we've been doing these past couple of months, Stephen Russell and I I've been going to all those territories with each of the two sale the two commercial people in each of those regions, and meeting with the clinical sites that we targeted in those regions to launch the product. And spending a few hours with each of those clinic clinical teams, and with our commercial team with us, at each of those sites, so that they get introduced to these folks that we've been working with for years, frankly, are as many of them. And so that's how we're doing it at first is we're sort of introducing the commercial team, to the people we've worked with over the years in the clinical setting the clinical research setting, and ourselves being introduced to the clinical people who aren't doing clinical research, but who worked with our clinical research scientists, collaborators. So that introduction is happening. And that's where we're focusing the launch. And then as we get experience in those eight territories in the fall, then we expand more territory, more territory. So we've been doing a lot of traveling, getting on the road and seeing a lot of these sites and moving back and forth across the country, you know, 17 sites in the past nine months, nine weeks.

Scott Benner 1:50:53
It's amazing, busy pace, because you're gonna go to the trouble of I mean, listen to this story, how long it took to make this thing. And now it's the last piece right? Like, how do you how do you set it in someone's hand? And it's not apples to apples, but I'm a person who's trying to deliver something to people too. And you would never know it? If I wouldn't say it out loud. But that's the hardest part of this job. It's making the thing is great. And then giving it to somebody is it's the hard part, you know?

Ed Damiano 1:51:20
Yeah. And that's it's all about scalability. So I'll leave you with this. This notion, if you think about what the diabetes control complications trial did between 1983 and 1993, was to test the hypothesis, right? This was a landmark study, many clinical sites across the country took 1500 people and randomized about half of them into conventional therapy, they called it which was not multiple shots a day, or insulin pump therapy was just one or two shots a day. And that and or intensive therapy where they were checking their blood sugar seven times a day, but importantly, they were giving multiple shots many times a day or using a pump. And what they found was they could dramatically reduce me mean glucose and HPA when see in the intensive therapy group and sustain that for a period of you know, six and a half years on average for each person at a huge effort on the part of the patients who randomized to intensive therapy, and the physicians that supported them, the clinicians that supported them. And they were testing the hypothesis back then it wasn't known that good glycemic control was necessary to stave off long term complications of diabetes. That was that was a contested point back in the early 80s. And until we had the HBA when C test, and insulin pump therapy and fingerstick meters, we couldn't really test the hypothesis. You know, if people take a bunch of people and control their glucose, well, do they have fewer long term complications and those who you don't. And resoundingly, the DCCT, the diabetes control and complications trial showed us it by 1993, that huge, markedly reduce long term complications. And that study took about 10 years to do. And 30 years ago, this month, it was read out to the diabetes community that you got to do this. Well, you know, 10 years after that study, we started building the bionic pancreas. And in that 10 year period, and we've been doing it for 20 years, but in this period after the DCCT, what we also found is it's not scalable, you can't do what the DCCT did in a large scale everybody's anyone see is more like in the eights low eights, not seven, which is what they're able to do with the DCCT. So it wasn't for 30 years after the DCCT that there's a device now that we think and reach broadly, a much larger audience than than most diabetes tech people with type one, that is something you can put in your pocket and you type in your body weight and do these few meal announcements a day and keep it going and get glucose control that's comparable to what the DCCT achieved in the intensive group. And so we sort of answered the question, is there a scalable solution here? And I think the eyelid is that is that device now

Scott Benner 1:53:41
it sounds like it. I mean, I've really appreciated you telling me so much about it, but I'm excited for you to to get it going and get it out there. How long do you think it'll be? It's June till I see somebody online going. I use an eyelet. Online Yeah, like sighs thanks a picture on their Instagram. Like when am I going to see that? Like,

Ed Damiano 1:54:01
in a month, really less than I think in a month? Okay. I think we'll have one or two people at the ADA conference next week on the island. Okay. But on Instagram, I think, you know, on social media, I think you'll see something come up within the next

Scott Benner 1:54:11
month. Pretty amazing. Okay, Ed, thank you so much. I really appreciate Of course, Scott.

Ed Damiano 1:54:15
Thanks for having me.

Scott Benner 1:54:26
Hey, huge thanks to Ed for coming on the show today and telling us all about eyelet. I also want to thank us med for sponsoring this episode of The Juicebox Podcast. I'll remind you to go to us med.com forward slash juice box or call 888-721-1514 To get your free benefits check so you can get started with us med check out that private Facebook group Juicebox Podcast, type one diabetes on Facebook. It's absolutely free. It's for everybody. I don't care what kind of diabetes you have. I don't care how you eat. There's a beautiful community there with over are 40,000 people in it waiting for you? This podcast is sponsored every week buy great companies. I'll list them in a moment. But if you have the need or the interest, please use my links. When you're finding out more, it really does help to support the podcast. If you want to check out the Omni pod Dexcom us med that contour next gen blood glucose meter Chivo hypo pen, athletic greens, cozy Earth BetterHelp touched by type one, they're all there. Just look in the show notes of the audio app you're listening in now or go to juicebox podcast.com. When you click on those links, you're supporting the production of this podcast and keeping it free. The podcast is sponsored today by better help. Better help is the world's largest therapy service and is 100% online. With better help, you can tap into a network of over 25,000 licensed and experienced therapists who can help you with a wide range of issues. Better help.com forward slash juicebox. To get started, you just answer a few questions about your needs and preferences in therapy. That way BetterHelp can match you with the right therapist from their network. And when you use my link, you'll save 10% On your first month of therapy. You can message your therapist at any time and schedule live sessions when it's convenient for you. Talk to them however you feel comfortable text chat phone or video call. If your therapist isn't the right fit for any reason at all. You can switch to a new therapist at no additional charge. And the best part for me is that with better help you get the same professionalism and quality you expect from in office therapy. But with a therapist who is custom picked for you, and you're gonna get more scheduling flexibility, and a more affordable price. I myself have just begun using BetterHelp betterhelp.com forward slash juice box that's better help h e l p.com. Forward slash juice box save 10% On your first month of therapy. Thank you so much for listening. I'll be back very soon with another episode of The Juicebox Podcast

#933 The Doser

David's son has type 1 diabetes and we go down some rabbit holes.

+ Click for EPISODE TRANSCRIPT

Scott Benner 0:00
Hello friends, and welcome to episode 933 of the Juicebox Podcast.

On today's program, what am I my grandmother is it 1978 My programs on on today's episode, I'll be speaking with David. He's the father of a child with type one diabetes. And he and I go down a number of different rabbit holes together. The topics of those holes are lost on me at the moment, meaning I forget. But while you're trying to figure it out, please remember that nothing you hear on the Juicebox Podcast should be considered advice, medical or otherwise, always consult a physician before making any changes to your health care plan or becoming bold with insulin. Alright, you ready three quick ways to save money. Your first month of therapy@betterhelp.com forward slash juicebox will be accompanied by a 10% savings for using that link. If you want to start with ag one from athletic greens, you will get five free travel packs in a year supply of vitamin D with my link athletic greens.com forward slash juice box. And you can save 35% off your entire order at cozy earth.com When you use the offer code juice box at checkout

this episode of The Juicebox Podcast is sponsored by touched by type one, go to touched by type one.org. Go to their events tab. And you'll be able to get tickets to see me speak live pretty soon. It's June now. So I mean, in a couple of months if I'm if I'm not forgetting the date, I could look on my calendar, but it's like touched by type one.org. Go check them out. The podcast is also sponsored today by cozy Earth. The last thing I do tonight before I go to bed, I'm going to take a shower, and then I'm going to tell off with my new cozy Earth towels. What a joy, what a joy this is going to be you can get those same towels and save 35% at cozy earth.com When you use the offer code juicebox at checkout, they also have bedding and lounge where all kinds of great stuff. You can't go wrong at cosy earth.com

Unknown Speaker 2:30
I guess everybody says that. So

Scott Benner 2:33
you know it's funny. I think most people are nervous. I think if you listen you can hear dissipates in the first 10 minutes. Usually. Some people hold on to it the whole time. Some people think they're not nervous than they are. But I don't know how you wouldn't be you know, it's not something you do every day. I'm not nervous. Just say today, but I'm as cool and calm as you can possibly imagine. So let's get in fact right now I'm thinking to myself, do I want to sneak a look at what David said when he when he sent him his his choice of dates or do I just want to wing it? That's literally where I'm at at the moment.

Unknown Speaker 3:08
I don't even remember what I sent it without that.

Scott Benner 3:10
See? Now that makes it interesting. Okay, introduce yourself real quick. You don't need to visualize them.

Speaker 2 3:15
Okay, I'm I'm David. Live in Wisconsin. I have a son with type one diabetes. He's was diagnosed in August of 2019 2020 21.

Scott Benner 3:26
Three years this summer. Yep. Have you ever been on another type one podcast? No.

Unknown Speaker 3:35
I've never been on a podcast. I'm reading

Scott Benner 3:37
your I'm reading your, your intake. Hold on one second. I think Do you think people were just amazed that I have any kind of system at all employees? They're just like, wow, this guy thought this through a little bit. Your tea one parent have not been on a podcast. Some of the things you're hoping to cover? Parent type one. Oh, you said how on the pod Dexcom. And the podcast improve your life.

Unknown Speaker 4:02
Call it Oh yeah.

Scott Benner 4:03
You call it the diabetic Trinity. Yeah, if anybody's wondering, that's how they've got on the show today. Now before that I before you even said that and I asked you to come on. So why don't we talk a little bit about it. So let's get a little background here. Do you have type one? Oh, no, I don't anyone else in your family have it besides child?

Speaker 2 4:25
So before my son had it, you know, everybody was like no, nobody has anything but then after dig in a little bit, my my mom's grandma had it. And my mom's cousin had it.

Scott Benner 4:42
Oh, your mom's grandma. Okay. I see that that's a little far away that your mom might have been too young to know about that.

Speaker 2 4:51
Yes, she after like after like I guess reimbursing in you know into it like shots and all that kind of stuff. Then my mom's like, Oh, I remember when I was a kid. Like they taught her how to give her cousin a shot. So, but now she's like, she, she doesn't like doing that she she like, is afraid of, you know, given shots. So I don't know if her having to do it as a kid was, like, gotten traumatizing or what?

Scott Benner 5:23
I love that you're like, does anybody in our family on this like, no, hold on? Yes. Yeah, this

Speaker 2 5:30
Yeah. When you you know, when you're having a kid and everybody's like pulling up all the you know, history, like our doctor asked, like, Do we have anything and you know, I'm texting everybody and everybody's like, no, no, we're good. We're good.

Scott Benner 5:46
When you said you dug deeper, what did that mean? Did you just look at them and go, are you sure?

Speaker 2 5:50
Yeah, I was like, you don't? Like nobody in our family has this. And then my mom's like, oh, yeah, I forgot. I was like, oh,

Scott Benner 6:00
did she say that Wisconsin accent did she go? Oh, my god like that?

Unknown Speaker 6:04
No, I don't sound like that.

Scott Benner 6:05
Do I know of course nothing. Okay. Just a little bit. It's okay. I can't or I can hardly hear it. Okay, so that's interesting enough that that just under pressure, it sounds like your mom's childhood trauma kicked back in and she was like, wait a minute, I do remember this.

Speaker 2 6:22
Yeah, the first time she was like, go ahead, give him a shot. And we use it's called a shot blocker. Well, we don't use it anymore, because we have Omni pop, but we use a shot blocker and my son's like, Yeah, I can't even feel it. And my mom was like, shaking like her hand was shaking. She was like, I don't want to do that. So I'm like, that's fine.

Scott Benner 6:41
Doesn't matter. I'm not doing it one way or the other. Well, that's that's, uh, maybe she'll get there. I don't know. It's been three years now. She was probably like, get a pump

Speaker 2 6:48
kick. Yeah, she Yeah, we got the Omnipod. She's like, Oh, this is awesome.

Scott Benner 6:52
Now I'll watch your kid again. Yeah.

Speaker 2 6:55
My dad, like never fazed him. He's like, What do I got to do? I'm like, just do this, this and this. He's like, okay,

Scott Benner 7:01
yeah. Well, you know, I understand that. So did you ever but

Speaker 2 7:05
obviously, he didn't have to do it when he was a little kid, just his cousin. So

Scott Benner 7:09
I don't know. He might have remembered it as fun. Your boys and girls can be different in waistline. Like, wait, I get this that my cousin? Amazing. Bring it to me. Do you ever find that cousin tracker? Tracker down?

Unknown Speaker 7:20
So my mom's cousin did pass away?

Scott Benner 7:23
Oh, that must have been incredibly encouraging to you. Yeah,

Speaker 2 7:26
I was like, what and there, but I don't I don't know if that had anything to do with it. Or, you know?

Scott Benner 7:33
It's hard to find out too.

Speaker 2 7:35
Yeah, I really haven't. I really haven't just dug into it yet. I guess.

Scott Benner 7:40
Did she pass earlier than you would expect a person to?

Speaker 2 7:44
Um, well, I think it was a I think her customer was a guy. Oh,

Scott Benner 7:47
I'm sorry. No, it's okay.

Speaker 2 7:50
I don't even know the age. But I want to say like 40s. Somewhere in that. So yeah, quite probably quite earlier than normal.

Scott Benner 8:00
That was earlier than I was hoping to go for sure. So yeah, as I was growing up, was saying I gotta at least make it through my 40s. Right. Okay. All right. Well, let's not look into that right now. Because his situation is very likely incredibly different than than yours. So tell me a little bit about the diagnosis. How did it go down?

Speaker 2 8:20
Um, so it obviously summertime, we had actually gone to the doctor prior, because he was kind of having those symptoms. So, you know, wetting the bed, like two, three times a night. So we went to the doctor, and the funny thing was, so I'm an EMT. So I was like, I something's wrong here. You know? And but I hate to like WebMD stuff, you know, that always sends you down. Like the worst. The worst path? Oh, yeah, sure. So we got some, you know, appointment as doctor took him in. And he kind of talked us out of it. You know, he was like,

Scott Benner 9:00
I don't do this very often, but I clicked the wrong button. And for a half a second, I was not recording, you just started. My apologies. The doctor tried to talk you out of it.

Speaker 2 9:10
You know how kids can wet the bed. And even though my son, you know, didn't for a long time, just like, like normal kids. And he went back to wetting the bed. And so he kind of talks us out of it and goes through a bunch of stuff and, like, just keeps kind of leading us away from anything medical. And it never, I don't know, it didn't sit well with me. But you know, like you've said in the past, like doctors have this, like, ability to kind of lead you and you just trust them then. So

Scott Benner 9:53
also delay. Let me say this, I think pediatricians have a job, and they just kind of assess what's going on. The town and then they try to apply what you're saying to what they notice happening. Because most of the time kids don't have type one diabetes. And so they're they're looking for what makes the most sense. The problem is you didn't know that you had autoimmune in your family, because WebMD and rabbit holes, leading you to bad things. Sometimes it's more accurate when you have autoimmune issues in your life. So

Speaker 2 10:23
yeah, I've kind of as stuff has popped up, I've kind of noticed that, you know, like, like my girlfriend she has she had some thyroid issues. And then I was like, well, you should look at other because she was having like eye issues. And I was like, well, from the podcast, I learned that if you have one kind of autoimmune, you might have another you know, you're more susceptible. So she started doing her own research and found about like Graves disease. And that's that ended up being what she had.

Scott Benner 11:03
Wait a minute, your girlfriend has graves. Yeah,

Speaker 2 11:07
graves graves I disease. I guess it's different than just graves. I don't really no, she's explained it to me. Pretty much like I've explained diabetes to her we have a basic understanding of it, but like, yeah, I guess there's issues with the eye it can. It can like bald a little bit she can get I think headaches. She has like blurred vision sometimes from it. She thought it was all the doctors thought it was you know, I issues. You know, kept sending her to put her get her glasses check. Oh, you need to you need a new prescription. And she's like, No, I've gotten multiple prescriptions. None of them help.

Scott Benner 11:45
Let me ask you a question. Just because you said something that threw me off a little bit. So let's start over. You're a person. You have one kid. Yes, I

Unknown Speaker 11:53
have one child.

Scott Benner 11:53
You have a girlfriend? Yes. He's the girlfriend. The child's mom. No. Ah, okay. So ironically, your kid has an autoimmune disease. And you found a girlfriend with an autoimmune disease. Yeah, look at you. Yeah,

Speaker 2 12:08
it was after too, like she, you know, we've been dating for a while. And then she was having these issues. And I'm like, you gotta gotta go to the doctor figure out what it is. And they were kinda send her down, you know, different paths. And she was she has like, the, you know, like, that feeling like, This is wrong. Like, I don't know what they're saying. And I'm like, Well, you think it's wrong then? We got to like, do our own research or something. Yeah, go to a different doctor or something. So but yeah, she did her own research and I think her her aunt was like, look this up and cuz she was like looking up like other autoimmune 's and then ended up finding out it. Yeah, she found graves. It was Graves disease. And then they they said it's just graves eye disease or whatever.

Scott Benner 13:01
Well, you're like a divining rod for autoimmune issues.

Speaker 2 13:04
Yeah. Unfortunate for everybody around me.

Scott Benner 13:07
Well, that's one way to look at it. Maybe you just have a gift? Who knows? Yeah, yeah. Oh, my gosh, well, I'm sorry for her she did she find? What is she doing for the for the AI stuff?

Speaker 2 13:20
Um, well, so there's, there's some medicine they have her on, which helps it and it's kind of just something you're I guess, stuck with. So but she did have like thyroid cancer, which like led to finding the eye disease. So they removed the thyroid. So that has, that can actually, I guess the doctor said there's a chance it might help the graves, like might not flare up or whatever is often so it's just kind of one of those things she's you know? Well, yes. So we'll live in with and learning about

Scott Benner 13:57
I'm googling here because I don't want to I don't want to test my memory while we're recording but Graves disease treatments, radioactive iodine, anti thyroid medicines, surgery. thyroidectomy comm Yeah,

Speaker 2 14:11
yeah. So she had she had a thyroidectomy not to fix the graves. But because they found cancer in there. Sure. So the doctor was like, well, side effects. This might help the graves. She was like, What is your lucky

Scott Benner 14:25
day? So did they take the entire thyroid or piece? Oh, yeah. Okay. So she's want to so that's interesting because now she needs a thyroid replacement. But if you have graves you need an anti thyroid medication. So maybe she's just on a lower dose. This is me guessing now.

Speaker 2 14:44
I don't know the exact dose I know. Cuz I think that's that runs in like your family too, right?

Scott Benner 14:52
Yeah, but hold on, give me a second. I'm scrolling Graves disease and thyroid eye disease which they call Ted need different medicines medicine for Graves disease treat the thyroid medicine for Ted treats the eyes. That's why medicine for one won't work for the other. Oh, so she is putting something in her eyes

Unknown Speaker 15:14
like eyedrops or whatever,

Scott Benner 15:15
I'm guessing.

Speaker 2 15:16
Yeah, yeah, she has. She has some eyedrops that were like prescribed and then there's some other stuff that they have her take. There's like one over the counter thing. I don't remember what it is. And then, and then some medicine because of the thyroid. But I knew I was at I was asking her like, well, what are your levels? Like, I even know what I'm talking about. And she was like, well, they wandered around here. And I was like, I think that's what I heard on the podcast.

Scott Benner 15:41
Well, then that's right, because I heard that on a podcast so you're all Yeah.

Speaker 2 15:44
Hey, I trusted him. I heard on this bigrams podcast I've definitely trust because it's tends to be correct.

Scott Benner 15:52
That's very kind of you and, and somehow scary to me, but thank you, I do my best. Okay, well, that's interesting. Anybody else around you have auto immune if you do sniff them out at work or anywhere else.

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Unknown Speaker 20:11
I'm trying to think I don't. I don't think anybody.

Scott Benner 20:14
Alright, so maybe you're not a divining rod then nevermind. Yeah, I

Unknown Speaker 20:17
just found a couple. Yeah.

Scott Benner 20:18
So how old is I'm sorry, your son, right?

Speaker 2 20:22
Yeah. So he was born in 2012. So he'll be 10 this summer. Oh, okay. So he was about seven when he was diagnosed. Yeah, he just turned seven because his birthday is at the end of June and then he was diagnosed in the beginning of August. Okay,

Scott Benner 20:34
before we keep going. Is there a dog in your room pushing around on the floor?

Speaker 2 20:38
Yeah, I got a little. A little Frenchie. He's is he loud?

Scott Benner 20:43
Whatever he's doing. I find myself wishing he wasn't doing okay. Let me crab is give him something softer to play with.

Unknown Speaker 20:52
Yeah, he was definitely chewing on something or put a

Scott Benner 20:55
carpet in the room or something. I don't know. Is that a hardwood floor? Oh, no,

Speaker 2 20:58
that was his teeth on the bone. That was his like, breathing. Oh, okay. He was like snorting while he was chewing his toy.

Scott Benner 21:08
Heisei. Oh, over here. It sounded like something clacking on the floor. My obviously Basil is mostly a French Bulldog. And but his snorting is intermittent. Like you won't notice him and then all of a sudden. It's there.

Speaker 2 21:23
Oh, yeah. He hasn't snorted all morning. Yeah. Just he's like, Oh, you're on the podcast. And now it's time.

Scott Benner 21:30
I think that guy's recording his voice. Yeah, it's crazy. Anyway, nice dogs. A little stupid, but in a nice way. I don't know about yours. Mine is a little

Speaker 2 21:40
dopey. Oh, no, he's he's pretty smart. He's a little puppy still, though.

Scott Benner 21:45
Oh, wow. Well, good for you. Mine's mostly okay. And then the dumb the dumb things he does are incredibly stupid. You're just like, Wow. All right, buddy. Anyway, son's diagnosed? What were the symptoms? What drew you to believe it? Um,

Speaker 2 22:01
so he had the, the extreme, you know, Bedwetting, that was like the big red flag. And then.

Unknown Speaker 22:09
And then he he was with his mom. She's a dog that's like, really?

Scott Benner 22:15
See now I made you aware of the dog.

Speaker 2 22:17
Yeah. So then he was with his mom. And she had called me and was like, I'm taking him to the hospital, he's vomiting. And she's like, something's wrong. So her, you know, intuition. Kind of was like, I need to take him to hospital. Something's, something's wrong. So we ended up going, there's a, there's a Children's Clinic in our, like, in our city. So we took him there. And now. So like, I don't know if I said it before, but like, I'm an EMT firefighter. So I used to work in this area. So I know some of the hospitals but I, I'd never this clinic is new, so I really didn't know it. So we took him there. And they they start going through their questions, and then the doctor, like, I can see it in his face. You know, I work with, like, you know, doctors and nurses every once in awhile and stuff. And I was like, something that he knows what's what it is like he has in his mind, but he's not telling us yet. I was like, okay, that's, that's weird. So they're like, we're gonna do a blood sugar. And I'd actually thought about doing a blood sugar like I was at the store earlier that week, like, Man, I should just buy one of these and just, like, test it and see. And I was like, after a visit with a doctor or whatever. It's, it was like, Oh, I'm just, I'm just overthinking this. So the doctor test his blood sugar. And it's, I want to say it was six 670 or 690 or something like that. Wow. So really high. So immediately, then I knew. And then they the nurse, I think, actually, I think it was the nurse that tested cuz she left. And then his mom looked at me and was like, what does that mean? And he was like, It's not good. So, like, one of the things we get taught in EMT is like, like a sweet breath sounds like hey, just breathe on me. So he's like breathing on me. And I can, it just smells like Starburst. And I'm like, did he have any candy before? You know, on the ride over here? And she's like, No, no, he can't. He couldn't eat anything. And I was like, Okay, well, I'm like, home like he has diabetes. And then she was like, Are you sure? And I'm like, I've like never been more sure. Yeah. So I'm the doctor. comes in. And then he's like, we can't do anything here. And I was like, What do you mean, you can't do anything here? He's like, Well, we can't even give IVs here. And I'm like, Well, this was a waste of time. So, so I'm like, Okay, well, when we're gonna go to the hospital, and he's like, you need, we need to call an ambulance. And we're like, right down the road from the hospital,

Scott Benner 25:23
not not for nothing to if they call an ambulance, and you were working, you might come to pick them up. So yeah,

Speaker 2 25:28
well, now I don't work in the area. So like, I don't know. Like, I maybe in the past, I would have known the guys, but I don't, you know, I didn't know any of them. And so I was like, well, that, no, I'll just take him to the hospital myself. And they're arguing with me. No, it's a liability thing. And blah, blah, blah. And I'm like, yeah, let me sign an AMA, which is basically like, yeah, basically relieves them, if anything, were to happen to my son, you know? And so

Scott Benner 26:00
I know that from Grey's Anatomy, that's all. Okay, thank you.

Speaker 2 26:06
So, the doctor is like arguing with me. And he's like, Well, fine, go up front, and sign it. So I go up front and sign it. And then nothing happens. Like, my son's not there. His mom's not with, like, what what was going on. So I like, tried to go and back and the door's locked, because it's a clinic. And I'm like, I need to go back there. So I go back there. And the doctors like still, like, you know, kind of arguing with her, like, pressuring her into calling an ambulance. And I'm like, Dude, I know how this works. Like, it's going to be three minutes before they get in the ambulance, it's going to take them five to seven minutes to get here, they're gonna have to load them up, they're gonna have to do stuff that takes three or four minutes, then the drive there, even if their lights and sirens is, it really doesn't save that much

Scott Benner 26:50
time. If you just shut up, we could get there before.

Speaker 2 26:52
I'm like, I could have them there in four minutes. Like, I'm like, it's fine. And they're, like, really adamant about it. And I'm like, then just call an ambulance. So hands up going by ambulance, to the local hospital. I told him because there's two hospitals. So I told them which one that I want him to go to? And then yeah, of course, I got in the car. And I beat him there by about, I don't know, five to seven minutes. Like I said, I would.

Scott Benner 27:21
Hey, I want to take a little detour for a second, how long? Let me start at the beginning. Where you and his mom ever married? Yes. Okay. How long have you been not married? At this point?

Speaker 2 27:32
I'm about I want to say, like a year and a half to two years, somewhere around there.

Scott Benner 27:40
Would you describe your co parenting as like, nice, like, up until then? Was it going well? Or did you not talk to each other very much. I'm trying to figure out how this it was.

Speaker 2 27:50
It was going pretty good on I'd say, I'd say before that scale one to 10. It was like a six or seven. You know, it's I mean, your divorce for you know, a reason. You know, so there's always that, but, but when it came to my son, I thought it was going pretty good.

Scott Benner 28:08
Okay, David, I have to tell you, I'm married. And I think communication is six or seven sounds like when you said that. I was like, well, they get divorced for Okay, so you guys are getting along. Okay, so it wasn't difficult for you to be in the room together or any of that stuff.

Speaker 2 28:26
No, no, I mean, not for you. And I obviously I can't Yeah, I can't speak for her. Right. But, um, you know,

Scott Benner 28:35
outside possibility. She's standing there thinking oh, this.

Speaker 2 28:38
Yeah, yeah. Oh, yeah, of course. Okay. I got there's definitely a possibility. But yeah, for I mean, for me, I, you know, I've always tried to just like, look at it, like, you know, what's the best for my son? Like, if I have to be in an uncomfortable position, but it's best for him then. Then that's fine with me. You know,

Scott Benner 28:57
excellent. No, no, I just want to understand because as we move forward, I feel like it's gonna unfold. So I didn't want to not have context go in there. Alright, so you're at the hospital. You get done waiting for your son to arrive. They do they take you at your word that he has type one because you're like, you just came from the clinic? You don't well, that over? Yeah, so

Speaker 2 29:15
well. I just told the like, receptionist I'm like, so there's an ambulance on the way. My son's in it. And I just said he has diabetes. I really didn't know. You know, I knew one of them you for the basics. I knew one. You basically took insulin and one you you know, took a pill. I was 90% sure it wasn't the pill one. And I was like, Yeah, this one's gonna be a little bit harder than you know diet and exercise and that because obviously he's a nine year old kid that was was playing soccer at the time as like it's not like he's you know, out of shape or anything like that.

Scott Benner 29:53
Well, that's a really it's interesting to to hear. To hear you talk about it from an EMT. perspective because I've heard it from a nurses perspective. I've heard it from a I've there been physicians on here whose kids have been diagnosed who have been diagnosed themselves. But an EMT like I think it's interesting for people to hear that, like, what you knew was a number above a certain thing meant diabetes.

Speaker 2 30:18
Oh, yeah, I knew that. Yeah, I knew that, that that high was just because, you know, we're looking at, at the kind of, like, 120 is our, you know, normal range. Obviously. There's other things that can, you know, raise that and actually listening to the podcast has been a lot more context because say, we have like a patient at my work. And, you know, their their blood sugar's say 180. But I know that they're super stressed out, and maybe, or they've just ate or something like that. You've heard that context of that it's a really well, that's why you know, the adrenaline or whatever,

Scott Benner 31:03
right? Not an emergent problem, but something that happens to people that you don't know, you never know, because you're not testing their blood sugar usually. Yeah, that's interesting. Well, I'm glad I can help it work. Okay, so,

Speaker 2 31:15
yeah, you've made you've made me the resident expert. At work.

Scott Benner 31:20
I would like to let all the people of Wisconsin know that they are welcome. In a very, I'm making a benevolent wave right now. I'm really joking. Well, how long were you in the hospital?

Speaker 2 31:35
Um, let's see. Okay, well, so. So then they they transported him from that hospital to children's in Milwaukee. And then we were at Children's Milwaukee for, I want to say maybe three days.

Scott Benner 31:57
Okay. brought his monitor down slowly started. Yeah,

Speaker 2 32:01
yeah, they had them. Some kind of some kind of, I don't know if it was like a, you know, policy or something that they had him in the ICU the first night. And I think it had to do just because he originally was like, vomiting. Yeah. So they, they had him in the ICU the first night, and then they moved him the second, like day into just a regular room.

Scott Benner 32:30
Well, he was probably NDK when he got there. Yeah, I think so. Yeah. So it takes a lot more takes a lot more nursing takes different equipment to you know, to slowly bring your blood sugar down in a safe way. They do not want to just like Jack your blood sugar down very quickly. So

Speaker 2 32:47
yeah, he had like, basically was a, like a bag hanging of insulin and a head went through a pump, and then it would like, like dosage? And then they would they would just check in like every hour to make sure it was coming down.

Scott Benner 33:04
At this point, does he lived mostly with you with his mom? Or is it pretty equal?

Speaker 2 33:10
It's pretty equal. I mean, a lot of it deals with my, my schedule at work. So okay, that's like a huge factor. But he's definitely with, with with us, like split 5050 is as much as possible. I mean, obviously, stuff comes up and we will swap days or whatever.

Scott Benner 33:27
Yeah. So you both they're becoming educated and doing it together.

Speaker 2 33:32
Yeah, yeah. So we're both we're both in the hospital. Doing, you know, all the in hospital education. Of course, I'm, my family always jokes, like, I love to do research. And I really don't, I just kind of get down those rabbit holes. I start, you know, reading about something and then it sends me somewhere else. And then somewhere else. And next thing you know, I've spent like three hours reading about something or whatever that I've been looking up. So yeah, I did. Immediately. I was like, I want to I want this thing called a Dexcom. And I was like, in my insurance don't cover it. I want the because I think Abbott made one at the time to leave, or whatever. Yeah. So I was like, I was like, I want this one. But if I can't get this one I want this one.

Scott Benner 34:18
Said I want the I want this one. But if I can't have that one, I'll take the cheap one.

Speaker 2 34:23
Yeah, I was like, I was like, I don't care. I want this thing to tell us all the time.

Scott Benner 34:26
Right. What do you end up getting?

Speaker 2 34:29
We ended up getting the Dexcom it took a little while obviously. I ended up like, you know, calling Dexcom and having them kind of start the ball rolling and then calling my while his endocrinologist they wanted to have us test for a while, you know, the, I guess the same old routine that almost everybody goes through.

Scott Benner 34:54
Just tell them I can actually test at the same time he's wearing a Dexcom

Speaker 2 34:58
No, I didn't think about that. But I was like, why not how to do this? And they're like, What do you mean? I'm like, Well, we have to test the blood sugar at pretty much every patient at my job. Like, every time we pick up a patient, we test their blood sugar, you know, if we think it's that or not. And, okay, so it's like, I'm pretty sure I understand how I got this down. comedor works. I've been using it. Yeah, cuz I've been doing. I've been doing this for like a decade at that time. I'm like, Yeah, I've been doing this for a long time. Like, I know how to do I know how to use this.

Scott Benner 35:32
Well, how soon after he got out of the hospital? Did you have a CGM?

Speaker 2 35:37
Oh, um, I know, we went through the whole summer. And then some of the some of the winter without it. Because I know some stuff came up. I know we were. We were in. I want to say we're like doing like, the Chicago zoo, like you walk through the lights. And I was like, Oh, I just had a, I just had a CGM, this would be so much easier because I had to like test them and stuff. And you know, if it gets high, then I'm like, trying to get it back down or whatever. And so

Scott Benner 36:17
an insurance thing that made it take that long? Or was it the doctor pushing you back?

Speaker 2 36:23
I think it was just a little bit of everything, you know, a little bit of the insurance, they had some rules, like you have to, you know, test this many times a day, and this and that. And obviously, we had the prescriptions that prove that. So it just seemed and then the the doctor's office, oh, we want you to, you know, do finger sticks for a certain amount of time. And just like a little bit of everything kind of piled up. So I ended up calling my insurance and finding out, you know, what do they cover and all that kind of stuff? So I did, I did kind of all the legwork, so that I didn't like pick one and then and then get everything approved. And then they're like, Yeah, your insurances and pay for this.

Scott Benner 37:08
But so you were pretty ready. By the time it came, you knew how to how you wanted to use it and what it was going to do for you?

Speaker 2 37:13
Oh, yeah, I had, I had a basic idea of, you know, what it did how it worked, you know, watched a bunch of YouTube videos, you know how to put it on all that kind of stuff. So I was like, ready to go when it came in the mail. And like, let's do this. And they're like, they had like, a zoom, like a Zoom meeting with, I think, with a Dexcom nurse or something like that. And they were like, Oh, we got to do this. We get like, I want to put this thing on now.

Scott Benner 37:41
We I've been thinking about this for a few months. Now. I'm good to go. I know where I want to put it. I think I know how to insert it. Let's go. What did you learn? Or did you learn anything? Shocking, or surprising? After you could see his blood sugar constant?

Speaker 2 37:57
Um, yeah, I we saw the, like, cars. So at first when they when they, you know, tell you it's like here, you get the you get the lunch or dinner or whatever ready, you figure out how many carbs it is, and then you dose for that. And then you give them the food. So like, originally, I'm thinking, you know, and this goes, I'm thinking it's more like a medicine that we give at work, you know, which is working through an IV in you know, a couple minutes, not realizing that, you know, some insolence take 1520 25 minutes to work. And so I'm dosing him. And then you know, when you check, whatever, three hours later, his numbers are good. Well, I didn't realize he was like, spiking, you know, 182 10 like, and then coming back down. So that was the biggest surprise to me. I was like, why is these huge spikes here? Like we're ending at the right area? But, you know, why are we Why is he spiking and then falling back down?

Scott Benner 39:01
Right? Yeah, no, I mean, I had the same experience. I just like I used to think they do this thing. Before CGM, they wanted you to test at certain times, and the times they would give you the test actually did give you the greatest chance, I should say, of getting a number close to what you were hoping for. So you know, test before you eat, make a decision off of that, that number, how much insulin you need for food and to correct this number. And then don't ask again for like three hours or more after they eat. And then you'll see where you ended up. And you're like, okay, and you know, gosh, I started at 150 I ended at 110. This went pretty good because in your mind, excuse me in your mind, you never went over 150 And you didn't go under 110 It's just how your brain like tricks you into believing this is what must have happened. You know that you throw that CGM and you see see one fit The winter 171 to 210, it was 280 that it dropped like a rock for five minutes, then it leveled off at 200, then it fell again and you know, then you test it and you are 110. And you're like, oh, everything's fine. It, it shifts your perspective. So once you know that, you want to make a change, what's the first change you make? And how do you figure out how to make that change?

Speaker 2 40:22
Well, then, I want to say the first change we did was, you know, start to start Pre-Bolus Singh and stuff like that. I actually didn't want to, like, so he's young. So I'm like, I don't I don't know, if I want him to wear a pump. You know, I was like, I don't know how how beneficial that can be. So we kind of tried all the other stuff, you know, trying to do a Pre-Bolus trying to find different foods that might not have like, such a hard hit because he was like a big, like milk drinker. And he used to love those like, those like, they're in the breakfast aisle, they're like, but they're, they're not just milk there, they got like protein and stuff like that, and I'm sure, and they had way more sugar than like some other brands. But, you know, we weren't paying attention to that beforehand. And I'm like, Man, these things have a lot of sugar in them. So you start looking at different brands like okay, well this, this might not hit as hard this, you know, this might not be as drastic. So I think the first step was like Pre-Bolus Seeing and trying to choose foods that may not have had like such a such a big effect on the on the sugars rising so fast.

Scott Benner 41:45
Is funny once you start paying attention what you learn about foods specifically, I people who don't have diabetes in my life, sometimes I'm like, don't eat that. Like there's nothing valuable about that at all, you know, or, or I'll say like, you have no idea what that would do to Arden's blood sugar. I'm totally interested in what it's going to tax your pancreas with. You know, like, there's just certain things. I mean, you know, you don't have to look at labels for very long, just certain things like this is probably not a good idea.

Speaker 2 42:13
Yeah, yeah, there's things. There's things that I eat and drink, and I'm like, Man, I wish I had a Dexcom on right now, I'd love to see how this how this affected me. I'm gonna

Scott Benner 42:21
say milk with added sugars. Definitely one of them. So yeah, but drinks are where, where we get so much sugar that people don't realize, you know, it just it comes in. I don't know. You know, it's sort of like, I don't know, it's sort of like a condiment when you're when you're counting your carbs. Like sometimes you forget to count the condiment, which has 789 carbs, and you're just like, Oh, that's not food. That's a condiment. And sometimes I think people are similar was, you know, drinks. They're like, Oh, it's not food. So I don't have to worry about its impact. But you get a lot of a lot of stuff goes in your body through your liquids, so you have to be really careful.

Speaker 2 42:58
Yeah, I'd never I never realized until you know until you see it

Scott Benner 43:02
had to look. Yeah. Well, that makes sense. So you injecting for how long? How long did your mom get off of having to babysit?

Speaker 2 43:12
So we injected for her for a while, like, I know. Man, I don't even know how long we've been on it. Probably. Probably coming up on a year. Now. I guess we've been on the pump. Right. Um, but it felt like forever. Like because we had, you know, we had that CGM. And then I, like I said, Before, I was kind of against the pump. I was like, man, just this is more stuff like, like, what do you you know, if the pump fails, you have to have a way to give it so you're still carrying the pen around. So it's like, I don't know if I want to do it. And then I think that's how I ended up actually finding your podcast is i i was doing like a little bit of research on the pump. Because his mom was like, I think we should do this. I think we should do this. I was like, Okay, let me let me look into it. And then I'll see it, you know, and I think I think I found the something about the Omni pod and then it like linked to your to your podcast. And then so I listen to your podcast. And then I was like, Man, I don't even like I don't even listen to podcast. So I was like, How do I even find, like, do this so I had just gotten an Apple phone. And it had the little like podcast app on there. I was like, I wonder if it's in here. And then that's when I started listening to it. And then I was like, oh, yeah, we're getting the pump. Let's get on this now. That's cool.

Scott Benner 44:46
You know, earlier we skipped over something. So you know, we you we talked about you seeing what was happening after meals. And did you then you jump to like talking about a pump because I think you're gonna tell Talk about how you started treating with a pump. But it didn't take that much time. Did you see what was happening with meals and just let that happen? Or did you? Because now you're telling me you didn't really find the podcast until the pump. So you wouldn't have really known about Pre-Bolus thing unless somebody brought it up to you besides me, did someone else bring it up?

Speaker 2 45:16
Um, I feel like I read it somewhere. Okay. You know, trying to cuz I know, in I didn't, I guess I didn't actually have a word for it. But, you know, I would see like, Okay, we injected here. Now, now we're watching the Dexcom. And he's eating. And then it's rising, and then it's falling. And it's like, you know, kind of putting two and two together. Like, they're, you know, why is it? Why is it doing this? Why is it taking so long to like, kick in? And then it made sense to Yeah, kind of on a on a basic level kind of made sense. I just didn't have like a term for it or anything like that. So I know we did. Because at first like, I would like dosage of like, give him his food now, you know, like in a panic and yeah, and you're all like, freaking out. If it takes like five minutes. And then, you know, come to find out. You're like, oh, no, he's got 10 more minutes before.

Scott Benner 46:17
You have a little more time than you think. I love I'm enjoying talking to a guy. How old are you? 36 you don't get to talk to as many men as I do women. And I love you have so many guy answers. Like if I said to you like David asked me what time of day my children were born? I'd say I don't know. But if you ask my wife, my wife knows the exact minute they were born. You know how long ago did Arden get? an insulin pump? Like I know that because of the podcast. But trust me if it wasn't for the pod? Yes. I have no idea. I I swear to you right now, if you asked me what day Arden was diagnosed? I don't know. It's like, later in August.

Speaker 2 47:02
You know? Yeah, it's it all kind of blended together. Because, like, I remember we, you know, I remember dosing with a with a pen, and it felt like forever. And I remember not having a Dexcom and that, you know, and it feels but it feels like I've had a Dexcom Well, he's had a Dexcom for ever now. And it feels like he's had a pump forever, too.

Scott Benner 47:28
Yeah, so just tell you all I know if that boy's mom was here, and I said, when did you start using a pump? She'd be like April 16. Two?

Unknown Speaker 47:36
Yeah, she would definitely have the dates.

Scott Benner 47:38
Yeah, I don't know. I enjoy this. I love the in specific nature of your answers, can I because I don't think it matters to be perfectly honest. But and I also think it's a good gets a good view into people's minds and how you know, life is busy. And you know, there's a lot going on with diabetes, obviously in your and your job and work and just trying to raise a kid in general. It's hard to remember all this stuff. And you know, it starts to blur together after a while and there's nothing wrong with it. I was just kind of teasing you. I thought it was hilarious. Okay, so now you've got a you got a pump. You've got the CGM. You figured out how to start Pre-Bolus thing. The pump leads you to the podcast. What does the podcast lead you to?

Speaker 2 48:20
It leads me to like, well, first. So I was doing the research on the pump found the podcast and then after listening to the podcast, because I was like, there's a lot of like, good info in this podcast. So me, I guess, being who I am, I went to like episode one. And just started listening. Because my my drive to work probably, it's almost I can almost fit a whole podcast in it. So I usually start it on my way to work. And then on my way home, I'll I'll finish it. And I just started hammering those out and finding out kind of how much you can manipulate the pump and find out you know how you can adjust the Basal rolls and do all that stuff. And so that's kind of where, you know, the podcasts and the pump led me to was on just having way more control over it.

Scott Benner 49:21
Not just thinking of the insulin was something that you put in then it goes off and does whatever it does, and you're just hoping it doesn't run you over. Yeah, that's good. I'm glad. I also appreciate when you went back to listen at the beginning. Thank you.

Speaker 2 49:35
Yeah, I listened let's say like 250 episodes before I like came I was like I need to hear stuff because you know there's so much stuff going on this past like year I was like I need to hear some like fresh new stuff because I actually found it interesting. In the beginning. I want to say it was before like dash came out. And I want to say But it might have even been before Dexcom six came out. So it I kind of liked to hear like, it makes me appreciate it, you know, you get that one bad Dexcom or you get that one bad pump, you know, something fails or whatever, but it makes me appreciate like what people had to go through with like the older the older technology, you know, yeah. They like I have no idea, you know, what a, what a whatever, G four, G five, whatever they, whatever, you know, setbacks or whatever they had. So like hearing other people talk about them and stuff kind of made me appreciate everything we got now.

Scott Benner 50:44
Yeah, it's funny how it ends up working because Arden's had them for a while I go back and forth, I think the seven plus was our first one, which I know is weird, because in current times people think of G five, G six, and G seven coming out soon. But there was a, you know, they went to a different naming system at G four, they started four or five, six, and now sevens coming. But nonetheless, it's just like every other technology thing, you get it, it's the best thing you've ever seen. And you're like, This is amazing, then you use it for a while, and you're like, This is amazing, but I wish it did this, or I wish it didn't do that, or would be nice. If this was round, or you know, whatever you start thinking. And the company thinks the same thing. They're like, Hmm, that makes sense. They hear feedback from people, they use it themselves, they go Alright, well, we'll make a little adjustment, you get the next one. And immediately you're like, This is the best thing I've ever seen. You know, and I just tried to imagine that at some point, there was a person in the world who was like, wait, I can buy a glass vial for my for my needle and boil it at home and keep it clean. This is the best thing I've ever seen. You know?

Speaker 2 51:53
Yeah, that's a crazy, that's even a crazy thing to think about, like boil stuff at home.

Scott Benner 51:59
last 100 years, though, just remember insulin, like people were only giving themselves insulin, it's literally 100 years this year. Like so, insulin is 100 years old and 2021. I know it's about 2022 now, but only by a couple months. So insulin is only 100 years old. And we went from Good luck, you're gonna die, you know, to hear inject this, this may be keep you alive to Hey, run around a lot. Don't eat carbs ever. Maybe that'll keep you alive a little longer. To know, we figured this out in check this people started living with diabetes. It sounds sad looking backwards, right. But prior to insulin, you got diabetes type one, you just died. Like that was there. You know, that's 101 years ago, I have diabetes, type one, I'm going to die. And then all of a sudden, here's some insulin, some people live really well on it, you hear some lucky stories from the beginning, people just went on forever. But even if you got people into their 30s and 40s, back then it was a huge win. Like, they got a life that they weren't going to get you know. And then

Speaker 2 53:03
that's like, that's a crazy thing that like even to consider trying to fathom

Scott Benner 53:07
everything from the past color's the future. So that's what slows down care sometimes is that sometimes you're talking to an older doctor who has a foot in the past. And they're just like, please, if you make, you know, there was probably a time in the last 30 years that they thought if you make it to 40, good for you. And now all of a sudden, people are saying like, look, there really may be no reason given current insolence and technology, that this even impacts the length of your life if you understand it early enough. I'm thrilled that you figured it out that early. You know, see that little thing People made fun of you for David goes down rabbit holes, it helped. Although in fairness, your ex seemed to know before he knew. She's like yeah, I

Speaker 2 53:51
was like, Why are you so set on a pump? Like why? Why do you want this? And then I started reading about it. And I was like, Oh, you're right.

Scott Benner 54:00
I bet you if you just said that a couple more times while you're married, you might say yeah. Oh, lesson learned. I'll tell you what the next girl is gonna be right about everything.

Unknown Speaker 54:10
Oh, yeah, she is my girlfriend's. Is that right about everything?

Scott Benner 54:14
I know it. David doesn't have money to do that twice. He's You're right. You're 100% right. We should definitely leave like we're gonna let the cat on fire because it seems like it's something you want to do. Let's do it. That's hilarious. Not that women want to like cats on fire. You understand? I'm sorry. I take that crazy idea. And yeah, I understand. I know you do. But there are women listening who are like I would never let a cat on fire. Like I know you wouldn't calm down. Oh, now I said calm down to women. Now I'm screwed right now you're done. I've been married how long? You're looking at me? In an attempt to be funny. I said the worst thing in the world that you're you're not allowed to say calm down to people.

Unknown Speaker 54:54
That definitely does not work. No, no

Scott Benner 54:57
it as the app listen I joke around with Are you in the Facebook group? Yeah. So do you know Isabel moderates the group for me?

Speaker 2 55:08
I didn't, I didn't know that much. I just I definitely try to, you know, inject where I can or whatever and but I didn't know like, I don't know any of the moderators. It's

Scott Benner 55:20
just what it's me and this lovely woman named Isabel who helps, you know, mostly what she sticks with is like, she jumps in gives like, pushes, like people like, Oh, you have a question. This episode will help with that, like she's doing that kind of stuff, which is really great. Okay, but we talked privately, and I joked with her recently, and I said, um, I'm going to write a book, it's going to be a short book, it's going to be called things you can't say to your wife, it'd be like a pamphlet and calm down. Definitely one of them. You know, just, I think how many lives can be saved? If you just,

Speaker 2 55:52
yeah, you just handed out at the wedding?

Scott Benner 55:55
Exactly. I think I told her, I'm like, we're gonna call it like, you can't say to your wife. Like, I'm gonna sell a million of them. And they're only they're only gonna be like, it's gonna be like three or four pages long, but it's gonna save your life. You keep it like a reference in your pocket. You feel yourself talking. You flip through it, and you go, Oh, yeah, I can't say that. Nevermind. Yeah. And by the way, there are things you shouldn't say to your husband either, but I don't see anybody sweating that?

Unknown Speaker 56:24
Yeah, they don't worry about that too much.

Scott Benner 56:25
Look at you. Generalizing. You said, now you're in trouble. Good. Get me off the hook. Excellent. So how would you say your son's doing now diabetes wise, what would you categorize? You know, his day to day like?

Speaker 2 56:41
Um, I'd say he's, he's doing really well. It definitely matured him. So that's kind of a it's a good thing, but also a little bit of a sad thing. But he, so we got him. Obviously, I use a lot of your advice. We got him a cell phone, which he has that school. So he's got everything there. And he's got his I don't know what's called PDM. We call it a dozer. dozer. So that's Yeah. dozer. So he, you know, if anything happens if he starts to go a little high, so I have his high set fairly high, just so it doesn't beep at school, which is 200. But mine set at 160. So if it, if mine goes off, I can just text him, like, hey, dose this much. And then he just goes up to his teacher tells her he needs to do something, she's like, No problem. And then he, they don't have desks. So he, he keeps everything in his backpack, which is like in the hallway of school. So he'll just go out in the hallway, if he needs to dose or if he needs, you know, a little piece of candy or something to bring him up, or, you know, whatever he needs to do. He can just go in the hallway, take care of it come back. And the teachers have been great about it. They, you know, every year we sit down and do the, you know, the prep for the school year, and they're, they're basically just like, what do you need us to do? What do you want us to do? But he's kind of getting to that age where he can do a lot of it himself. And I've started kind of like quizzing him, like, hey, what would you dose for this? And he'll say, you know, in the beginning, he would be like, Well, I don't know, I don't know. And I'm like, Just guess he's like, Well, what if I'm wrong? I'm like, Well,

Scott Benner 58:39
don't worry, we're not listening to your kid, I'm just wanting your guests

Speaker 2 58:42
know, I listened to you, I'll be like, I'll be like, if you're wrong, then we'll either give you more insulin because you need more insulin, or we'll give you some juice to bring your number back up. But then you learned from that. Okay, you know, now I know. You know, I'll say, Well, how many units is this? You know, we like 1.2, you know? And then I'm like, okay, yeah, if you need more insulin, you need more. So a lot of times if if I think he's close, I just, I'll go with it. And truthfully, a lot of times he ends up being more right than I would have been.

Scott Benner 59:15
I do that too. Honestly, I think it's a great way to teach them and let them see it in person. Like don't get me wrong if I thought some oh my god, hold on. I cannot wait for winter to be over. Hold on. I was so dry. I, you know, don't get me wrong if Arden was like I think that's 11 units. And I was like I think it's three I'd be like Oh, I think you're wrong, you know, but let's go over it. But I take your point like if you think oh no, this is three and he says three and a half I'm like yeah, whatever you think speaking of the old PDM from Omni pod he used to have to hold he might still have to one some of them you have to hold this arrow up to you know make the the number climb. You know when you're trying to decide how much insulin use I know most people probably Put the carbs and let the pump decide. But you know, I use a little more. And I just whipped that arrow up. And as the number was climbing, I just take my thumb off. And if I meant to get the five units, and it stopped at 5.3, I was just like, that's fine. I just got to put them being because my experience was I was frequently her blood sugar's were high anyway. So I mean, I guess I didn't have enough is how I was thinking about it. I was like, I have five 5.3. What's the difference? You know, I know, point three is the difference. But it's the scale, give it a shot. And I think you'll learn a lot from that by not being caught in that panic that you kind of described earlier about when you put the insulin in. Everyone knows that feeling like I've injected the insulin, it's an early on feeling with diabetes. Oh my god, start eating. Like right now, like 30 seconds passes in the beginning and you start to like, your flopsweat. You know, like, Oh, my God, this is bad. Like, you know, something bad's gonna happen. Now we'll Pre-Bolus You know, I don't know, 1520 minutes if we need to art and I own a restaurant the other day. And we were like, Pre-Bolus and walking through the parking lot. Just like Yeah,

Speaker 2 1:01:05
yeah, that's the that's the one I find hard. It's like, you never know how quick they're gonna be at the restaurant.

Scott Benner 1:01:11
Well, every once in a while, I won't lie, David, every once in a while you're sitting there going, where's the food? Where's the food, but you know, we've walked into a parking lot. We're in a lot of cars there middle of the day. I was like, go ahead. Like your budget was like 120 as a guide and Bolus, like not all of it, but let's do half of it now. Get it Get yeah, that's,

Speaker 2 1:01:27
that's what I did. When we went, we went out to eat with my dad. And I like Pre-Bolus I want to say like, like two thirds of the meal. And I'm like, I'll just give you the rest when it gets here. Because we use fi ASP. C ASP. So works pretends to, it tends to work a little bit quicker for him, so Oh, nothing bolusing now it's such a huge deal as it was before

Scott Benner 1:01:54
I we crushed that meal yesterday. Now the thing we messed up was that there were French fries involved. And we both kind of said like, you're gonna need insulin for the fat and the fries later. And then I like we went home and like, like parted ways. And I just forgot to bring it up again. And she forgot about it. And then next thing you know, I was like fighting with a fat rise, her and I were fighting with a fat rice for like two hours. And then we finally broke it and brought it back down again. But the meal itself like man like that Pre-Bolus was legit. We sat and ate her budget was like 88 While we were eating. And awesome. Yeah, it's not just awesome. It lets you sit there and talk like people instead of, you know, you go in you, you do what you do. And 10 minutes later, you hear like beeping Are you testing like, oh, it's already going up? It ruins everything, you know? So,

Speaker 2 1:02:46
yeah, kind of interrupts Yeah, you were conversation or whatever,

Scott Benner 1:02:51
it's hard to sit and just be you know, when you're trying to, you know, when you're chasing this number, when just you know, getting the insulin on the right side of the meals is pretty much all you need to do. So, anyway. Do you remember why you wanted to come on at this point? Or do you feel reasonably okay about this conversation?

Speaker 2 1:03:11
Um, I feel pretty good about it. I mean, I just, I just, I guess, appreciated, like hearing a lot of people's different stories, and, you know, just wanted to kind of share my story.

Scott Benner 1:03:26
Well, I really appreciate that, honestly, I, the podcast is it's nothing without people like you. I I mean, the management stuff is great. And I think it's terrific. And I could talk about it forever. But I don't think it would be as entertaining. And I don't think it would be as interesting and I think maybe great stories, hearing people's lives, draws people in, and then it allows them to go look for the management stuff. You know, I was talking to somebody I was pitching, I can probably tell you this hold on. I can tell you this, because by the time yours comes out, it'll be long past. So I was pitching the Helmsley foundation yesterday, on having somebody from their foundation come on the podcast. This is probably words you don't know anything about but there's a charitable foundation called the Helmsley Foundation. And suddenly, a number of years ago, they just shifted to starting to support diabetes, and it felt like it was almost out of nowhere. And it turns out that somebody that came in to the foundation has children with type one. And I was talking to a PR person yesterday talking about how I would like to have him on his name is David coincidentally. And yeah, and it really is weird because I don't think I've interviewed that many David's. So you know, I'm talking to her about what I think, you know, why would like the mother come on the podcast and you know what story I want to get. And I think at first she was sort of like this is different than what people usually ask about. You know, like they want to know about The foundation they want to know about, like what they're doing. And I'll get to that while we're talking. But I would really just like to hear what it's like for him to be the father of kids with type one and what drove him to do what he's doing. You know, just just a, an interesting conversation with a person like, no, no need to come on and read your manifesto, the information you want to get out into the world, because that's not interesting to people. And so I find somebody like you incredibly interesting, I feel, I feel like regular stories are assessable. And that people can find their way through, you know, through you. So I really appreciate you doing this. Not that, you know, the guy from Helmsley is not going to be really interesting. But if I just had on, I don't know, practice voices in the diabetes community over and over again, you would just hear the same four stories over and over again. So, you know, I really do appreciate you taking the time to do this.

Speaker 2 1:05:55
Yeah, I find that the stories, it's, it's kind of like, we, your podcast is kind of like how we train like as EMTs. And stuff, a lot of times, or even as firefighters, a lot of times you get somebody that's, you know, then, like they're teaching the class. So they'll teach you something in the class, but then they always have a story related to whatever they're teaching you. So, like, I've been learning kind of that way, since I've been doing this. And so when I found the podcast, I was like, I don't know if stuff really stuck with me. And I don't know if it's just because that's how I've been kind of learning through my career. So I just find it like, super easy to retain stuff that people say, and then I can, you know, look it up, do my own research, see how, you know, try it out, or whatever it may be. But yeah, that's, that's what I find super helpful.

Scott Benner 1:07:00
It's amazing. I'm happy that that it's valuable to I really am I just, it just, it's obvious to me that these conversations are important, and that they don't have to have any goal when they start. You know, like, I mean, honestly, you came on to say, you know, in your intake form, you just like, I don't know, like, you know, I liked the podcast, and we got some technology, but we didn't talk about any of that, really. And it's an insight into your mind and your situation. And then other people can hear it and find commonality and think, okay, like that worked for him, or didn't work for him. Or I could try this or maybe listen, maybe you guys are just listening to right now going, I can't tell my wife to calm down. No, you can't. You cannot tell her that it doesn't even matter if she's literally, if that's the best advice in the world, you're not allowed to say that. I could say it. I've actually had private conversations with people where they're really upset about diabetes. And I'll say, can I tell you something that I assume your spouse wants to say to you, but they won't? Like, you gotta come? Yeah, but you're out of your mind, like, just relax a little bit, you know what I mean? You can't just, you know, like, you can't just, you can't be at this level of panic constantly. It's not okay. But it's not a something, it's not something you'll accept from a person in your home. You know, you'll you'll accept it from a stranger. But anyway, somebody gets something out of this conversation. And maybe it leads them to another conversation, or leads them to a device or how to fight for something that they need with their doctor, whatever it ends up being like, it would be, it would be foolish of me. I think it would be foolish of anybody. But it does seem to be how some people try to do stuff, to try to take an hour of conversation and decide, this is what this is going to be about. And then I get you on and I forced the conversation into that direction. Because that's not fun to listen to. And then even if we do get to the thing, you know, that's on the title. It might be so stilted and uncomfortable that people just wouldn't listen to it to begin with. So I just say talk and whatever comes out comes out, and then we'll do it again tomorrow, you know? Yeah, I appreciate it. I really do.

Speaker 2 1:09:18
Yeah, the one. The one thing I'd have to say that, like, the podcast did that helped me out the most was to not just kind of take what the doctors like, want to do or what they say like, when we go into his doctor's appointments. I'll be like, This is what we're doing. This is what we need. This is how it's going. And his his agency has gone from above seven to let's see, it was 5.9. And then this last one was like 6.1. And my like, my real goal is like this Six. Like, if we can just stay around six, I'm happy anything better than that is, you know, a win, but I'm not trying to, you know, stress them out or anything. So I've I feel like we're, you know, hitting my goal. And when I go into the doctor's office, actually, so his doctor doesn't have type one diabetes, I found the most helpful people to talk to in the office are the nurses that have diabetes.

Scott Benner 1:10:28
I can imagine. Yeah, like, I can

Speaker 2 1:10:31
get so much good information from them. Like I saw a nurse wearing, she was wearing a libre. And I thought she was just wearing it to see how it feels tested out. She's like, she's like, Oh, I usually use Dexcom. But she's like, we had these laying around, and they're expired. So I'm just using them up. Like, oh, wait, you actually need that? And she's like, Yeah. And I was like, Oh, let me pick your brain.

Scott Benner 1:10:56
I agree. I think it's a great idea. Does you know what you just said made me want to ask you are you interested in on the pod five? Are you gonna try an algorithm?

Speaker 2 1:11:05
I want it so bad. I'm on the like, whatever the waitlist or the interested list or whatever. Because my son has, it's so weird Hill. And it doesn't matter what he eats. But at night, when he goes to bed, his sugar will just shoot up. And sometimes it's just so stubborn to get back down. And it's at first I thought it was like growth spurts because it would happen, then it would stop. But like sometimes it happens for like weeks and weeks and just never seems to stop. And then when it stops it only it'll stop for like a day or two and then it's back to like being super difficult nights.

Scott Benner 1:11:48
Yeah. Well, I think you're gonna get that that's

Speaker 2 1:11:52
yeah, I'm, I wanna, I'm interested in seeing like, what it does, because I've raised as basil at night, like, almost double what it what it is during the day. And it helps, but I'm just like, Man, I need this algorithm. I need to see what what it does. Tell me. I have a computer tell me what to do.

Scott Benner 1:12:10
Yeah, need to sleep to? Yeah, that's amazing. Actually, you know, I, I know this little like anecdote about on the pod that I pops in my head all the time. I always swallow it, because I'm not sure that I'm supposed to say it. But I'm just gonna say it now. So I never think about it again. You mentioned earlier you were like, the PDM. But we call it the doser. Yeah, so I know that there is a person who works at on the pod, really high up it on the pod who came into the company. And one of the things they said was, why are we calling this thing of PDM. It's such a clunky, like, weird name. But it was kind of so ingrained in the, you know, in the device at that point, they couldn't just like change it. And you know, and it stands for Personal diabetes Manager, which is just, you know, very indicative of probably, you know, they were starting the company, and they're like, What do we call this thing? And somebody probably said, like, it's a personal diabetes management, like, oh, okay, let's call it that. You know, but I think it's, it's, it's very, it's a very good thought that it would be cool if it had a better name. And I just when you said that, I thought, I bet that person wishes that was called a doser, or something else. But I wouldn't be surprised just based on what I know, if one day, that name just kind of like, slowly translates into something else. I always kind of keep an eye out for that to see if that ever happens. Because I know there's somebody in the company who's like, PDM why are we saying that?

Unknown Speaker 1:13:39
I know PDM sounds like so, like, 90s to me

Scott Benner 1:13:44
why they get it? And I think it is and then that's why so I bet you one day it gets changed. And if it ever gets changed, I'm gonna after it happens, I'm gonna get the person on the podcast who I know, would be spearheading that that movement, and get them to tell the funny story of when they got there. And they were like, What are we calling this? Anyway, I had to get that out of my head pops into my head like three times a month and I'm tired of it happening. I figured if I said it out loud, it would just be gone. So I appreciate it. Well

Speaker 2 1:14:11
tell them if they you know if they want to name it. doser I'm totally fine with that.

Scott Benner 1:14:14
Yeah, yeah. You don't have that copyrighted or anything like that. No. I think you'd be better off it was called the thing.

Speaker 2 1:14:22
I know. I'll be like, Hey, do you have do you have to get the thing? Oh, sir. You have the doser with you? Like yeah, I'm like, Okay.

Scott Benner 1:14:29
I know for certain that if you asked Arden what her Lance was called. I don't imagine she would call it a lance. I don't know what she would call it. I don't even think we call it anything. I hear people call it pricker. Or I've heard somebody say it was the stab or once and stab. I'm like, Oh, I wouldn't say that if I was you. But anyway, I don't even know what Arden would call it. I almost guarantee she doesn't know the PDM is called well, though she does because we would use that. We would say PDM a lot when she was younger. So I bet you that it's stuck in our head. But I don't know, I can't wait to see what they they end up calling it now. Or you know if eventually it'll just go to your phone. And you'll just go to your it'll be the Omni pod app.

Speaker 2 1:15:15
Yeah, that that would be so ideal, because I mean, him having him having his phone at school just makes it so much easier being able to text and stuff. And yeah, that would that would be awesome. You know, it's honestly, if they got it to an Apple Watch. Then after the phone,

Scott Benner 1:15:31
man, I just realized like, so it's launching with like, I think it's got phone controlling, like, I don't know, one Android at launch. And they're going to expand after that. But I just realized that language wise, you wouldn't call it anything once it was on the phone. Like when you look at your Dexcom, you don't think to open your Dexcom app, you just think that the place where you see your Dexcom is on your phone. So when you look at the app, that's your Dexcom to you. So because

Unknown Speaker 1:16:00
I'll I'll just ask them like, what's your number? Right?

Scott Benner 1:16:03
So it's not like it's even an app to them. It's a portal that you don't think about that way. So I imagine once phone control for pumps goes, you will won't actually need a moniker like PDM. It'll just be like, you know, we need to Bolus now. And then that will just be the place your mind goes to, to accomplish that. Like I don't think of Netflix as being on an app. But it is I just think of it as Netflix. Yeah. All right. I don't know why that's important to me. Language is interesting. So all right, David, thank you so much for doing this. I really do appreciate it.

Speaker 2 1:16:34
Yeah, thank you. Thanks for letting me come on here and tell our story.

Scott Benner 1:16:46
Huge thanks to David for coming on the show and sharing that story. And I want to thank cozy earth.com and remind you to use the offer code juice box at checkout to save 35% off your entire order, and touch by type one.org. That's where you can go find out about all the events in the goings ons and the things that doings that touched by type one does, the doings that they does are touched by type one.org. I have a little time here. So let me thank you so much for subscribing to the podcast. Those of you have been doing it this week. You've driven the show up into the top 10 In the US medicine category, and it's been staying there with some pretty big names. I really appreciate it. If you're not subscribed, please please do. Looking for community around type one diabetes, check out Juicebox Podcast type one diabetes on Facebook. That's pretty much all I got for you today. Thank you so much for listening. I'll be back very soon with another episode of The Juicebox Podcast.