FDA Approves Dexcom SHARE
I just received a note from Dexcom letting me know that their long-awaited SHARE device has been approved by the FDA!
The note went on to say that Arden was nominated by a Dexcom employee to receive the device as a gift which was an absolutely wonderful surprise that, even though I've never once accepted anything free in the eight years that I've written this blog, I am happy to accept. After reading the email I immediately watched this quick video about the device and had a rather unexpected response.
I was smiling as the video played, excited to try SHARE and happy that the FDA approved the device when out of no where the voice on the video said, "Telling parents where their glucose levels are... allowing a good night's sleep". I burst into tears. I am so incredibly tired from eight years of diabetes and broken sleep that the thought of overnight relief caused me fall apart for a moment. The mere idea that I won't have to get out of bed and walk across our house to check Arden's CGM is elating. From what the video indicated the SHARE does much more but at the moment, I'm just happy be able to stay in bed. The announcement from Dexcom isn't all good news as I am left with an amazing but now unless skill. You see, I can make turns in the dark without bumping into walls by using the indicator lights on our smoke detectors as my guide. Do you have any idea how long it took me to become proficient at that?
I'll be posting an in-depth review for you as soon as possible (Dexcom did not ask me to do that, actually the only thing that I was asked to do in exchange for receiving a SHARE is complete a short survey after using the device for 30 days). My upcoming review will include a detail disclosure.
In the meantime please join me in celebrating our new lives full of unbroken sleep and unstubbed toes. I can't wait to unburden myself from the anxiety of wondering if those three beeps mean a falling BG or just a fantastically stable number that is hovering a few points below Arden's indicator threshold.
The SHARE costs $299. You can find more information, see an overview, read frequently asked questions and browse all of the details about the SHARE on Dexcom's site –
Today is good day... I'm going to go watch that video again!
10/23/14: Arden's SHARE arrived today - see the unboxing pics here!
Take the DOC Asks the FDA survey
from diaTribe.org:
Please help us tell the FDA what truly matters to patients at www.diaTribe.org/survey - this takes five minutes and will help immensely. All the feedback will help inform a November 3 patient-led meeting with FDA drug/device leadership.
from diaTribe.org:
Here's the background - On November 3, the FDA will host an unprecedented discussion between the diabetes community and senior agency leadership (both drugs and devices). The event will be live webcast from 1 - 4 pm Eastern time, and will include a panel of patients (T1 and T2), as well as representatives from JDRF, American Diabetes Association, and diaTribe. As a community, our job is to present the numerous challenges we as patients face each day, and we need as many opinions as possible to be a part of this discussion! With JDRF, ADA, and dQ&A input, we have created a survey posted at www.diaTribe.org/survey. We are asking all people with diabetes to take the survey (~5 minutes) and share thoughts on what's important when it comes to living with diabetes. This feedback will go directly to FDA and help influence the conversation on November 3. The registration info for the webcast will be posted soon.
FDA and the Diabetes Patient Community
Patient Network Live Chat: Diabetes - Glucose Monitors and Test Strips
Talk with FDA expert Courtney Lias and
Patient Advocate Bennet Dunlap (Yea Bennet!)
about Glucose Monitors and Test Strips
Monday, March 31, 1:30–2:30 pm (EDT) Talk, share, and connect with the
FDA and the Diabetes Patient Community
Do you want to learn more about the role of the FDA in the regulation of medical devices, such as glucose monitors and test strips, used in the management of diabetes? Do you want to learn what the FDA is doing to increase the accuracy of blood glucose monitors and test strips?
When you participate in this friendly online chat, you will:
Enjoy an informal, open discussion with a fellow patient advocate, CDRH subject-matter-expert and others in the diabetes community.Learn more about the role of the CDRH, specifically the Office of In Vitro Diagnostics and its work to ensure the safety and effectiveness of medical devices used in the management of diabetes. Get your questions answered about the newest FDA draft guidances, which are proposing new recommendations intended to improve the accuracy and safe use of blood glucose monitoring test systems, giving healthcare providers and people with diabetes better tools to manage blood glucose levels.
Whether you want to just listen to the interview, ask relevant questions about the medical device regulatory process or just speak your mind on the newest draft guidance document…. you should join in the conversation.
Register for this event and be sure to mark your calendars and join us on March 31st, 2014.
FDA approves pediatric use of Dexcom’s G4 Platinum continuous glucose monitoring system
“The U.S. Food and Drug Administration today approved the expanded use of the Dexcom G4 Platinum Continuous Monitoring System for patients with diabetes ages 2 to 17 years.”
“We are thrilled with the FDA’s approval of our Dexcom G4 PLATINUM System in the pediatric population. Daily management is relentless, and parents can now have greater peace of mind that a child’s diabetes is under control, whether the child is at home, away at school, or participating in activities or sports.”
Update: via email from DexCom: 2-4-14
The G4 PLATINUM (Pediatric) receiver works with the existing G4 PLATINUM sensor and transmitter. No need to order different sensors or transmitters. The components of the receiver are the same. It has the same settings, alerts and it calculates and displays your sensor glucose readings the same way as the receiver you have now. The Dexcom G4 PLATINUM (Pediatric) Receiver has two additional screens at the ‘Start Sensor’ and ‘Low Alert’ Menu options. These screens are reminders that you should use your blood glucose meter for any treatment decisions and not rely on CGM only to detect hypoglycemia.
Links
Hey FDA, what about diabetes!?
From diaTribe:"The Food and Drug Administration has begun to hold a series of patient meetings to gain a better understanding of specific diseases. Over the next five years, the agency plans to conduct at least 20 such meetings on conditions ranging from Chronic Fatigue Syndrome to Narcolepsy to Irritable Bowel Syndrome.But not diabetes. That is unacceptable.Four “slots” remain open (view the current list), and we want the FDA to add diabetes to its meeting docket for 2013.According to the American Diabetes Association, nearly 26 million Americans have either type 1 or type 2 diabetes, and an additional 79 million have prediabetes. Those numbers are also increasing each year – the CDC estimates that if current trends continue, one in three US adults will have diabetes by 2050.No one disputes that diabetes is one of America’s – and the world’s – most serious health epidemics. In 2012, more than one in five total US healthcare dollars was spent on diabetes, totaling $245 billion, and the government covered 62% of those costs, meaning everyone is paying for this epidemic. Despite growing needs, research dollars have also leveled off.New therapies need to be investigated, tested, and brought to market, and as part of that process, the FDA must understand the daily challenges that patients face.We need to tell our story to the FDA: about the need for accurate strips, more physiologic insulin, a broader range of drugs, and the Artificial Pancreas.Our voices need to be heard.
Thank you very much."