FDA Advisory Panel votes 8-2 in favor of a non-adjunctive (replacement) insulin dosing label update for Dexcom's G5 CGM!
diaTribe attended an FDA Advisory Committee meeting July 21 on whether Dexcom’s G5 CGM (continuous glucose monitor) should be approved for insulin dosing. After a full day of presentations, deliberation, and public commentary, the FDA advisory panel voted 8-2 that the benefits of using Dexcom's G5 CGM for making diabetes treatment decisions outweigh the risks. The panel also gave an 8-2 vote on safety and 9-1 on effectiveness. The positive votes make it far more likely that the FDA will approve this important label update soon, which means that the device can be used for dosing insulin and replacing blood glucose fingerstick “checks” when warranted (there will be some times this is not advised of course).
The diaTribe Foundation put enormous effort into supporting this label update (including writing a letter to the FDA that was signed by nearly 10,000 people, giving comments in the letter [over 1,000!] and speaking during the open public hearing ourselves), as we believe it has the potential to truly make diabetes treatment safer, less of a hassle, and ideally more accessible for people with diabetes. The day's discussions had us at the edge of our seats, and we were absolutely ELATED when the voting results came in! We used Facebook Live Streaming for the first time ever at FDA to show the remarkable testimonies by so many patients and scientists and researchers working to influence the understanding of panelists and the vote - you can view the archived video on the diaTribe Facebook page here. Thank you so much to the nearly 2,000 of you who tuned in already … and to so many other in the community who wrote the FDA letters, like DPAC, ADA, AADE, AACE, the Endocrine Society, and countless patients.
Open Public Hearing Commentary
During the Open Public Hearing (OPH), over 35 patients, family members, healthcare providers, and patient advocates discussed the long list of reasons why this label update will benefit people with diabetes. Thank you SO much to so many superstars in the field who took enormous time from their very packed lives to share their visions:
- Incredible patients took part in the day, many of them leaders of advocacy efforts in diabetes, including Children with Diabetes CEO Jeff Hitchcock, College Diabetes Network CEO Christina Roth, Close Concerns’ head of diabetes technology/digital health Adam Brown, Diabetes Hands Foundation Founder (and current Livongo exec) Manny Hernandez, Diabetes Hands Foundation CEO Gene Kunde, DiabetesMine writer Dan Fleshler, diaTribe Senior Associate Ava Runge, DPAC’s Bennet Dunlap, JDRF Chief Mission Officer Dr. Aaron Kowalski, Joslin medalist Lynn Wickwire, National Federation for the Blind’s Eileen Rivera Ley
- Multiple families also participated, including Alice Dorn and her 15-year-old daughter Caroline from Georgia (patient of the famed Dr. Bryce Nelson) and Dr. Sarah Kimball and her son 10-year old Sam Mazlish from California, JDRF International Board member Lorraine Stiehl (and partner of Chris Stiehl, who has had diabetes nearly 60 years!)), and multiple other parents including Greg Dooley of Ohio and Khatereh Calleja of Washington DC
- Many of the field’s leading researchers and clinicians took part, including Dr. Aaron Kowalski of the JDRF, Yale’s Dr. Bill Tamborlane, BDI’s Dr. Bill Polonsky, the ADA’s Dr. Bob Ratner, UVA’s Dr. Boris Kovatchev, Baylor’s Dr. Daniel DeSalvo, Dr. Lori Laffel of the Joslin Clinic, Wash U’s Dr. Janet McGill, Johns Hopkins’ Dr. Nicholas Argento, University of South Florida’s Dr. Nicole Johnson, and U Colorado’s Dr. Satish Garg)
- It was also tremendous to see senior leaders from professional associations such as Mike Williams from AACE – Hope Warsaw of AADE also was present sharing her very important views from an educational perspective (although disappointingly, they did not present); other key doctors participated such as Dr. Gregg Gerety from NY
- In something truly unparalleled in our experience attending advisory meetings for well ove a decade, we even saw one competitor to Dexcom, Dr. Mahmood Kazemi from Abbott, speak in favor of the indication – this was truly inspiriational.
- We had a triple hitter from our teams at Close Concerns and The diaTribe Foundation – Adam’s slides are posted here for Close Concerns, Kelly’s slides are posted here and talking points here for the diaTribe Foundation, and Ava Runge’s slides are posted here for the diaTribe Foundation – all have diabetes (for a collective 50+ years).
What did the panelists share? So much!
- One of the major arguments was the fact that Dexcom G5 CGM users widely use it for insulin dosing already, but proper education (for patients AND healthcare providers) can't occur without the current labeling. Instead of receiving structured guidance and training, people with diabetes are currently learning how to dose via risky "guess and check", a big safety concern and compelling reason for approving the label update.
- Multiple OPH speakers also addressed the fact that fingersticks are burdensome, subject to inaccuracy from dirty fingers (which can show falsely high blood sugars), and are single, isolated data points lacking the rich context provided by CGM's 288 glucose readings and trend arrows.
- In addition, many noted that fingersticks are rarely taken more than the recommended six times per day in most type 1 patients (the ADA recommended this for anyone on intensive insulin management in 2016), which means that many people with diabetes dose insulin blindly without any glucose data at all – obviously a very big risk when dosing a potentially lethal drug!
- Other common themes included the benefits of CGM alarms and real-time data; the fact that only ~30% of type 1s currently meet treatment goals; and the importance of this label update for Medicare, who refuses to consider covering CGM without it being indicated to replace blood glucose meters.
I was BEYOND impressed by the passionate testimonies, compelling data, and moving personal stories shared during the OPH, which was truly the highlight of the meeting. To view it yourself, visit our Facebook Live Stream - see OPH Part I and Part II videos on the diaTribe Facebook page - please excuse all the commotion at the beginning of the videos, this was our first time streaming live from Facebook : >. We’re also sorry that we didn’t catch quite all the speeches due to the technical error of our phone running out of juice. ; >
See below for some of our favorite quotes from the meeting – more to follow, but thank you tremendously to the nearly 10,000 people that signed our diaTribe letter to the FDA and all the people that spoke at the Open Panel (here was the background on that and Adam Brown’s 60-second video on why it was important!). What a day to share our world.
- "The question of non-adjunctive versus adjunctive use of CGM, with all due respect, is silly. It's what people with diabetes are already doing." – Dr. Robert Ratner (American Diabetes Association)
- "My ask is simple. Let's catch up with the times and have the FDA approve CGM for what it's already being used for in the real world." – Manny Hernandez (Livongo)
- "Approving this label will keep people with diabetes safer and allow proper education for those who are dosing off CGM now from trial and error." – Adam Brown (Close Concerns and diaTribe)
- "CGM gave me proactive information that let me avoid fluctuations and not just react to them." – Christina Roth (College Diabetes Network)
- "My wife has not given me glucagon for severe hypoglycemia once since I started on CGM. Before then, it was every few months." – Lynn Wickwire (Joslin Diabetes Center 50 year medalist)
- "69% of Dexcom users regularly use CGM alone to adjust insulin doses. Today's label update is already in practice by many." – Kelly Close : >