Can the Diabetes Community respond to FDA’s Challenge?
FDA is holding a hearing on July 21 to consider a labeling change application by Dexcom for the Dexcom G5®. This panel will not wait for patient voices; they will vote on the 21st with or 
without our input.
The hearing will consider labeling for the G5 to be a “replacement for their blood glucose meters and make treatment decisions based on the interstitial fluid glucose concentration reported by the CGM.” This would mean less fingersticks beyond calibration. Many individuals are already making treatment decisions off CGM readings, but currently, this is considered “off-label.”
FDA flat out Challenged the DOC – Are We 5,000 Strong?
During FDA’s Artificial Pancreas Webinar with DPAC on June 2, Dr. Lias spoke specifically about the July 21 hearing. From my perspective, and I was there, FDA flat out challenged our community, “If people want to organize together and submit… a single comment with a lot of signatures that’s one thing… ‘this comment represents 5,000 of us.’”
Why Your Signature Matters
Coverage is based on labels. The change FDA is considering will help people with diabetes get and keep CGM access. 
CGM coverage hinges on providers seeing it as a primary, necessary tool in diabetes care, rather than just secondary to fingerstick blood glucose monitoring. Medicare currently does not cover and continuous glucose monitoring because, they say, CGM is not a primary tool. Some private payers are following Medicare’s lead and putting up access barriers to CGM. This replacement labeling is critical to covered access to CGM.
DPAC Makes It Easy To Matter
DPAC has drafted a letter of support. (Full text as PDF)
Here’s an excerpt:
We enthusiastically support the application to advance the label for accurate continuous glucose monitoring systems.
As people living with diabetes, we have a unique perspective of risk. Insulin is a very dangerous drug; too much or too little have both immediate and long-term complications. Those who use insulin daily manage dosages to mitigate these risks. We rely on a complex combination of treatment protocols created in collaboration with our healthcare professionals to make rapid self-management steps throughout the day.
We intimately understand there is no perfect diabetes path.
The American Diabetes Association Standards of Care recognize that “one size does not fit all.” They go on to emphasize that “for optimal outcomes, diabetes care must be individualized for each patient. A critical part of optimization is putting the appropriate tools, with the right labels, in the hands of the patient.
All devices, medications and management plans have risks. We accept these tradeoffs as part of the balance of daily life. We seek out high-quality tools to help successfully take careful steps that strike a balance between the possibility of an immediate health emergency from too much insulin and the likelihood of long-term health complications from not enough.
Signing takes a few clicks and adds your support to the 5,000 signatures needed. Click, fill in your name, and submit.
They are not waiting.
Act by July 14th and we will get the letter and signatures to FDA to be part of the materials circulated as part of the panel packet before the meeting.
What are you waiting for?
Act Now.
CGM’s need to be covered for everyone!!!
Don’t take away our coverage!
I agree that CGMs should be covered for everyone, but will that label lead to glucometers and strips NOT being covered? I love my son’s Dexcom, but it is sometimes way off.
Great question! In an article by MDDI, this was said:
As this is already been approved in Europe, there hasn’t been a restriction of access to glucose monitoring supplies, and the importance in this case is the term “safety check to ensure proper sensor performance.”
My 13 year old nephew is a type 1 in Belfast and the National Health System has not covered cgm’s yet. On top of the fact it will not affect glucometer or test strips because patients dont pay for their supplies. In the USA if they cover cgms i can see them limiting test strips even more than they do now for some families as they will say its no longer a necessity for those with cgms
I absolutely love my Dexcom. But, no way would I dose without pricking my finger. Just two nights ago I felt low but my CGM said 112. I did a finger stick and my blood sugar was 38. It is very frequently more than 10 to 20pts off. I feel this is incredibly dangerous. I use my Dexcom more as a guide to see my ups and downs and how I respond to different food etc. more to remind me to test rather than to take the place of testing.
I support the use of CGM’s and feel they need to be covered by ALL insurance companies. Why not make life a little easier and painfree for Children and Adults. This device is a Godsend for parents of children that are Diabetic.
Please cover our CGM’s
This is needed by many! Including my daughter
Wishing you guys all the luck you deserve.
CGMs need to be covered by all insurance companies! I am currently on Medicare, and lost my CGM, and because I’m a diabetic with hypounawareness it is dangerous for me to not have continuous monitoring.
Hope they get it covered for medicare
I check twice a day, a totally nessesary part of my monitoring, hope this is covered, as well as all supplies. Fixed income doesn’t allow for medicine.
Hope for coverage
Check twice a day, a totally nessasary part of my control, we need Medicare to cover all supply’s, being on fixed income.
Went to pick up insulin today, my husband past with diabetics my insulin was $288.00 at his death, now today it has gone to $365.00. How can fixed income keep this up? Do something to help diabetics.
I hope this passes and Medicare will cover any necessary supplies. I loved my cgm before I had Medicare. I cannot afford the cgm now.
I cannot afford the CGM and Medicade does not cover them.
Please cover CGM’s!!! They are so vital!!!!
I am tired of running my BG higher in order to avoid lows when I go anywhere. It is frightening to go anywhere when one does not have symptoms of low BG until it is too late. Thus I am labeled as “non-compliant” which is a loophole for insurances to deny coverage for CGM’s. Stop putting up barriers for healthy living and the ability to perform daily activities that allow us to be productive. While I would still check more than the 2x’s needed to calibrate, I can understand that this may not be what others want or need.
Praying for coverage
This for my great nephew Roberto.
CGM’s are a breakthrough in science that allow a diabetic to better manage their health. It is imperative any diabetic who wants to use one can have access to them.
Hope for coverage
My son has brittle diabetes and autism. The CGM is a vital piece of equipment to help guide him in his care of diabetes. Since the cgm his A1Cs have stayed below 7.3. Coverage is absolutely necessary.
Capitalism has no place in healthcare.