Can the DOC (diabetes online community) respond to the FDA’s Challenge?
FDA is holding a hearing on July 21st 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.
During FDA’s Artificial Pancreas Webinar with DPAC on June 2nd, Dr. Lias spoke specifically about the July 21st hearing. From our perspective 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.’”
“It was very clear during the June 2nd FDA/DPAC webinar that the FDA wants people to join together in a message to share our views on CGM technology,” explains DPAC co-founder, Bennet Dunlap. “Just look the FDA’s page about the Artificial Pancreas Webinar, they have a highlighted box about the July 21st panel meeting at the top before any of information about the webinar.”
This is what the July meeting is really about:
“The July 21st panel is there to consider risk, who knows better than those who live with CGM how it should be used?” explains Dunlap. “This is not about perfection. We all know there is no perfect in diabetes. We also know about balancing risk and that the CGM is a critical tool to do that.”
You can make a difference by sharing your concerns with the FDA and signing this petition.
ACT NOW: Sign DPAC’s letter to the FDA.
Mr. Patricio Garcia
Food and Drug Administration
Center for Devices and Radiological Health
Bldg. 66, Rm. 1116
10903 New Hampshire Ave.
Silver Spring, MD 20993
Subject: Docket No. FDA-2016-N-0001, Intended use of Dexcom, Inc.’s, Dexcom G5 Mobile Continuous Glucose Monitoring System (CGM)
Dear Mr. Garcia,
Thanks to FDA for considering the views of people whose lives are impacted by diabetes as part of your consideration of the Dexcom G5 labeling application. This letter is inspired by FDA’s June 2 webinar on artificial pancreas in which Dr. Courtney Lias encouraged patients sharing views in a joint letter. FDA’s openness in that webinar and this process is greatly appreciated.
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.
Continuous glucose monitoring (CGM) helps mitigate risk in a way no other device can.
The term used in this application is “replacement” however bringing CGM and meters “to parity” is perhaps more accurate. Equal footing is essential. CGM give us the ability to proactively address some risks of using insulin. You will seek to assess risk by considering a vast array of facts and figures leading to the July 21 hearing.
Facts and figures are important but just as important are the faces of those who live with this risk.
We live the risk of insulin; we know CGM is lifesaving.
Many of us have learned that CGM is as, or more critical, to risk mitigation as any tool available to us. We also know that access to CGM hinges on it coverage providers seeing it as a primary, necessary tool in diabetes care, not adjunctive. Therefore, replacement labeling is critical.
CGM is an increasingly valuable tool to mitigate risk for older Americans. And they are at risk. A recent JAMA article estimates that insulin puts ninety-seven thousand Americans in the emergency room each year. That is more ER visits than the government estimates are caused by stimulants, including methamphetamine. That insulin beats “Breaking Bad” is shocking. More shocking is that the vast majority of those ER visits are our Seniors, members of our Greatest Generation.
The benefits of CGM reach across all age ranges. Modern CGM systems facilitate the sharing of glucose data to third parties. This creates the opportunity for an extra layer of safety and protection: a view of our diabetes instrument panel.
Parents can remotely see the glucose of a sleeping child, enhancing safety. Sharing allows any person with diabetes to have the safety of support, at school, at work, and those adults, especially seniors, living alone.
CGM provides critical insight into both directions and rate of change of sugar values. That helps us be proactive and prevent lows and highs.
We can set alarms that allow our focus to be on productivity as students, working professionals and in our personal lives.
CGM automates data collection. That in turn facilitating fine tuning of care plans.
We trust that the evidence will help you see what we, the people for whom you are attempting to balance risk, already know. CGM is a critical tool, primary in successful lives with diabetes.