Happening Today: FDA Advisory Meeting on Dexcom Label

Diabetes Hands Foundation is excited today to participate in the FDA Advisory Panel meeting as they vote on a non-adjunctive label claim for Dexcom’s G5 CGM. The FDA has posted the briefing documents here (although a majority of it has been redacted). If approved, the labeling on the Dexcom G5 CGM will be changed to language that allows users to replace fingerstick blood glucose testing for diabetes treatment decisions (like administering insulin).

Diabetes Hands Foundation CEO Gene Kunde will be speaking at the meeting to represent the views of our community and we have also submitted a letter that parallels the comments Gene will be making. Read the letter below.

Another letter signed by more than 1,000 people penned by diaTribe will be submitted to the panel. And the Diabetes Patient Advocacy Coalition (DPAC) collected over 6,000 signatures on its letter of support.

July 21, 2016

Center for Devices and Radiological Health
Food and Drug Administration
Bldg. 66, Room 11
10903 New Hampshire Ave.
Silver Springs, MD. 20993

RE: Docket Number FDA-2016-N-0001

Dear Members of the Medical Device Advisory Committee,

My name is Gene Kunde and I am writing this letter as the CEO of Diabetes Hands Foundation, a patient-led nonprofit organization that has been providing information and support to people touched by diabetes since 2008. We provide platforms for connecting, sharing and empowering, and currently serve over 110,000 registered members. Last year more than 5.1 million visitors came to our sites and experienced 24/7/365 access to information and support that enables people living with diabetes to take better care of themselves and realize improved health outcomes.

We are pleased to submit these written comments to the Food and Drug Administration regarding Docket Number FDA-2016-N-0001 relative to a proposed change in intended use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System (CGM).

In preparation for this input we surveyed our members and learned that over 80% of survey respondents support the application to enable patients to use the Dexcom G5 as a replacement for blood glucose meters (BGM) and to make treatment decisions based on the interstitial fluid glucose concentration reported by the CGM.

In fact, most (about 54%) are already using the CGM data to make treatment decisions. A label update will allow these patients to have honest communication with healthcare providers as well as give Dexcom the ability to officially educate patients on dosing insulin based on CGM readings. This sharing of knowledge by Dexcom may come in the form of appropriate warnings and educational material to help patients make better decisions and/or to warn of potential risks. Currently, our research suggests that they are making these decisions without useful reference materials or guidance.

Many patients are currently using fingerstick meters that are not perfectly safe and accurate, and BGMs that do not meet ISO and FDA accuracy criteria. Because of this, the accuracy of the Dexcom G5 may actually be better than BGMs. About 40% report that they rarely repeat a blood glucose measurement because they do not believe a CGM reading. Only 13% report double-checking with a BGM once a week because they do not believe a CGM reading.

CGM also adds redundancy resulting in safer decisions. Trend arrows, remote monitoring, and alarms have helped reduce the risk of an insulin overdose when compared to fingerstick meters alone. One community member wrote, “I primarily use the [Dexcom] G5 to make all of my decisions. Before Dexcom I was doing 6-7 finger sticks a day and now only do the required two. The trending diagrams on Dexcom are much more valuable than individual finger sticks and also help me determine management decisions. If I had to make the choice between finger sticks or Dexcom I would choose Dexcom without reservation.”

Unfortunately, there is no device on the market that is 100% accurate and reliable when it comes to blood glucose testing. We ask the FDA to favorably consider the replacement claim which we believe will bring quality of life benefits to patients who will no longer need to take as many fingersticks.

We are thankful for the committee’s review of the proposed change in intended use of the Dexcom G5 CGM system, as well as this opportunity to present our input. We recognize the value of this process as an opportunity for the FDA to protect patient safety, enhance the quality of life of people living with diabetes, and to promote product innovation in the diabetes space.

As a representative of a growing community of people touched by diabetes we look forward to future opportunities to provide the patient’s perspective as input in the review of FDA regulatory issues. Thank you for your consideration of our voice and thoughts.

Sincerely,

Gene Kunde - CEO
Diabetes Hands Foundation

2 Likes

There is definitely a nuance to giving a bolus from a Dexcom G5 reading. I hope there is more than just a blanket statement cautioning the risk of doing so.

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I never bolus from my dexcom alone unless I have also done a finger stick too. This current sensor has been very accurate but at times it is very inaccurate. Sometimes if I think the dex is more accurate I bolus something like an average of that and the finger stick depending on which direction I think bg is. I just hope this added new language won’t cause people with dexcom to not have test strip materials or be forced to bolus from dexcom.

“I just hope this added new language won’t cause people with dexcom to not have test strip materials or be forced to bolus from Dexcom”

I have the same issue with occasional very high variability between the G5 and finger sticks. I would hope that if Dexcom requires 12 hr calibrations that test strips will still be covered by insurance.

I think test strips will still be covered but of course there is always a concern for us.