Health Canada Approves DexCom G4
DexCom announced yesterday at their May 1, 2013 Earnings Conference Call that...
"On the international front, we are pleased to report that we have received approval from Health Canada to begin marketing the G4 system in Canada. Our initial approval is for adults only. However, we expect to file supplements seeking pediatric approval later this quarter. Our distributor in Canada expects to commence a limited launch at the beginning of Q3 with the full launch commencing before the end of Q3"
Congratulations to my Canadian friends who have been patiently waiting to use DexCom's G4 system!
Oh Canada, I have new OmniPod info
Over the weekend I received more then a few queries from fellow OmniPodders that live in Canada. All were wondering when they can expect the smaller OmniPod to arrive north of the border. So I tied a tiny electronic note to a digital sparrow and released him into the Internet. This encouraging bit of news is what came back...
"With U.S. FDA approval now in hand, we can move forward with our regulatory filings in Canada. We hope that we would begin selling the new OmniPod in Canada later in 2013." - Brian Roberts, CFO, Insulet
There you have it Canada, I hope that this was the kind of news that you were all hoping for. It's not concrete but Insulet is willing to tie themselves to a date, however vague, and I think that is worth be optimistic about. I'll let you know more when I do.
Oh, you know what, while you're here. I've been wondering this my entire adult life... What's a Canuck? Seriously, is it a bird, plant, slang or none of the above? I need to know, please. Thanks!
New OmniPod Pictures and Information
It's official! The next generation of the OmniPod Insulin Management System has been approved by the FDA!
I've just finished speaking with Sean Gallagher, Senior Director, Marketing for Insulet, person living with type I diabetes and OmniPod user. We spoke for a bit this afternoon and I have some fresh information about the new Pods and PDM to share.
The name remains the same: You won't be wearing the OmniPod G2 or OmniPod Lite. Just good old OmniPod.
Pricing: There will be no price increase for the new system.
Transition: Insulet has been working for "18 months" to make the transition to the new smaller pod "easy" and fast for us the users.
How the upgrade happens: Current OmniPod users will receive an email stating that upgrading is possible. All you have to do is contact them back to get the ball rolling. Sean stresses that the process will be super easy, fast and efficient. They are working hard to make the transition a pleasure.
When? When can I get them?: There is some training of staff, endos and the like that's happening now. Expectations are that those steps will be finished and the new Pods will begin being delivered in the first quarter of 2013. I know you feel like you've heard that before but this time the ball is completely in Insulet's court, they have control, I'd bet anything that this time frame is accurate.
More when: For customers that are currently under warrantee. Your new Pods will arrive after you've exhausted the stock that you have in your home. Upgrades will happen at re-order only.
Any insurance stuff to worry about?: Simply, no. If you happen to be outside of your warrantee there will be some steps to take between Insult and your insurance company but Sean assures me that most of that process will happen on their side of the equation, requiring only a minor amount of effort on your part. The man said, "easy" is their goal, I believe him.
Interesting technical stuff
- The insulin reservoir capacity remains the same even though the pod is smaller.
- I asked Sean, "how did your R&D people accomplish the size reduction?" He responded simply by saying, "they're brilliant!". The slightly more technical reasons however include, the insulin reservoir shape has been changed to an oval and flattened. Plus the new Pods require only three, instead of four batteries because of enhancements that lessened power requirements.
- The new PDM has a dramatically improved stated signal range of five feet, but between you and me, I've seen and used one during FDA required Human Factor Testing... I'd try backing up if I was you.
- The smaller Pods have a new feature called a 'pink slide.' When the cannula deploys correctly, it pushes a piece of pink plastic to be visible through a new, second window on the top of the pod's surface. You can use this together with the regular viewing window for additional confirmation of insertion. - Info and picture added at 5 pm on 12/14 after second conversation with Insulet.
Why the long wait:
I expressed to Sean that the long wait for the newer, smaller, lighter OmniPod made me wonder if they were ever going to see the light of day in the U.S.
Sean indicated that the Human Factor Testing requirement from the FDA was in it's infancy (my word) when they were seeking approval and that both sides lived through a learning curve. He did stress that he genuinly belives that the "process is valuable" and when I asked if it was fair to say that the process provided me (and you) with a better, safer insulin pump, he did not hesitate to say, "yes".
Sean closed out our discussion with two thoughts that I will share.
He hopes, for two reasons, that those of you that may be preparing to begin pumping with OmniPod don't feel as though you should wait for the new Pods to become available. His first point (that I can completely agree with) was simple. The current version is a great device. I can't argue with that. If you start today you will be using a wonderful insulin pump, one that has benefited many including Arden for years. His second point was a reminder that the transition to the new Pods will be so easy that it won't even cause a blip in your day to day life. So there's no reason to wait.
I'm choosing to include his thoughts, that you may read as marketing (and perhaps it is) not just because I believe in the company, but also because I know that Insulet is a small company. I don't know for sure, but I'm willing to guess that they wouldn't do well financially with a less then normal amount of new customers over the next three or so months. That's my honest take on this issue, I make no secret that I'd like Insulet and OmniPod to thrive, it's good for my daughter and for all of you that wear the pump.
Lastly:
Sean wanted all of us to know that he and Insulet appreciate all of our paitence during this long journey. He is thrilled by the reception that OmniPod receives in our community and is touched by the eagerness that the new generation OmniPod is being greeted with. He said, "I am happy and excited to put the new OmniPod into hands".
Now for the pictures, you know you want to see the pictures!
Hi-Res version are available in the Visual Record section of the blog.
I have good news about the new OmniPod for my Canadian friends right here
Pathway to Stop Diabetes
Image courtesy of Pathways to Stop Diabetes
The American Diabetes Association has just announced an initiative called Pathways to Stop Diabetes. Here is a brief snippet from their website about the program's intentions.
We realize that it takes more than natural talent for young researchers to realize their full potential. It takes comprehensive support every step of the way. To make the career commitment to diabetes research attractive, fulfilling and rewarding, Pathway to Stop Diabetes will provide that support in every way.
I think that it's very exciting to see such a large organization thinking about research in a different way. It's also encouraging to see that program financially backed so significantly by pharma companies. I hope you can take a few minutes to learn more about Pathway.
If you are a brilliant young scientist, are raising one or know a young researcher that may be interested in being at the forefront of discovery. Please consider diabetes research as your field of focus. Pathway offers researchers mentoring, grants and much more. Who knows, maybe you're the next Frederick Banting, MD.
More blurbs from the Pathway to Stop Diabetes website:
"Our vision is simple yet revolutionary: find a new generation of brilliant scientists at the peak of their creativity, then provide them with the freedom, autonomy, and financial and professional resources to set them on the road to breakthrough discoveries."
"Diabetes research is critically underfunded. Twice as many Americans have diabetes as have cancer. Diabetes is over 20 times more prevalent than HIV/AIDS. Yet National Institutes of Health (NIH) funding for diabetes is 1/5 that of cancer and 1/3 that of AIDS. On a per-person-affected basis, diabetes funding is a rounding error in comparison. This difference has persisted for decades." - more
Arden's Day wishes the Pathway program a very successful (but hopefully short) life!
Be well,
Scott
Feel World Diabetes Day 2012
I've spent some time recently thinking about what World Diabetes Day meant to me, what did I want from it, what did I hope it's existence would leave for those that witnessed or participated. On Monday night I found the answer to my question...
Arden brushed her teeth before bed, she put on a silly pair of pajamas and climbed under the sheets. Her voice called to me and said that she was ready to be tucked in. When I entered her bedroom she had the lights out, her face was illuminated softly by a stream of dimmed light from the hallway. Her eyes were closed, she was pretending to be sleeping so that she could try and scare me as I approached. I stopped halfway into her room to tease her, she was trying so hard not to move, carefully holding her lips together so that she wouldn't smile. I looked at her face for a long moment before I sat next to her so that she could scare me. She popped up, I acted frightened, and then we laughed. We talked about the next morning and she expressed how happy she was that I was able to schedule a play date for later in the week with one of her friends. It was a wonderful few moments, some of the best that I had that day.
Our party was crashed seconds later by the electronic beeps of Arden's CGM. Three beeps to be exact. It's urgent bells told me that her blood glucose was falling, I looked at the clock but I knew that it was doing so far sooner then I planned. Those beeps brought me right back to reality. We tested and continued to mess around, Arden's spirit was unchanged. I decided that Arden needed a juice box, she didn't want it, actually Arden hasn't enjoyed a juice box in some years because they feel like medicine after all this time. I could tell by the slight change in her face that she didn't want to drink the juice but she didn't make a fuss. I smiled and continued to talk about the next day as she forced herself to drink. It occurs to me now that we were both putting on a brave face for the other.
I hope that World Diabetes Day allows one new person to see my blog today, anyone's diabetes blog really. I'd very much like it if as many people as possible could understand more about type I diabetes. I'm not talking about the tried and true stuff. No talk of how many shots or pokes, those things suck but you can't fully appreciate them if they aren't your reality. But feelings, we all understand feelings.
This may seem on the surface to be a minor thing, a petty inconvenience but please trust me when I say that it's very much more. I sat on the left side of Arden's bed as she forced down a juice box that she didn't want. She did it so that she could go to sleep without worrying that her BG would fall to a dangerous level, she did it because she had to, did it because that's what she does. She tried to keep the happy in her face, tried to hold on to the joy that we made together only moments before. She did a good job, I may be one of the only people in the world that could have seen through her mask.
Watching my daughter with that juice reminded me that there are forces in each moment of her day that manipulate her life. These moments aren't scripted, we don't know when they will happen, how they will end or if we are responding to them correctly. They demand that we stop living and pay attention to them so that we may continue to live. It probably only took her three minutes to consume the juice, but those minutes and all of the ones like them, they steal from us and they take more then time. My hope for WDD is that someone takes the time to understand a little better that which is the life of a person with diabetes, and that they feel as best they can what it means to carry type I through each day. I think that understanding will make an advocate out of even the most casual observer, and that understanding will lead all of us to a brighter tomorrow.
Arden hates drinking juice, I loath having to ask her to do it. Each time acts as a mallet that strikes at my soul. I can't be sure of what it does to Arden, I probably couldn't handle knowing. Please don't think of this as a story about a juice box, it's a story of a chronic disease and it's effects on an innocent person. I began this post with the intention of describing the sadness that watching diabetes do what it does has on me, but I can't find the words. I guess I'll simply say that it hurts, physically hurts me. It changes me. Some days and in some ways for the better, sometimes for the worse, but I am inarguably changed.
November 14th is World Diabetes Day, November is Diabetes Awareness Month, people that live with diabetes do so bravely each and every second of their lives. Please try and feel what that means, let it change you.