The upcoming July 21 Dexcom FDA hearing presents an opportunity for patients, family members, and healthcare providers to join together in support of an urgent issue: whether Dexcom’s CGM should be approved as a replacement for blood glucose meters for making diabetes treatment decisions (e.g., insulin dosing). Today, I am calling for support for this indication, which will have significant implications for patients and providers alike.
The diaTribe Foundation is committed to amplifying the voices of patients and their caregivers in the regulatory process. It is at the heart of our mission. I truly believe that this form of empowerment has the potential to accelerate positive change, create better therapies, and ultimately improve the lives of people with diabetes.
Below, I’ve summarized the most important potential effects of the Dexcom CGM label update (as emphasized in our recent diaTribe coverage):
- Medicare coverage. A replacement claim for CGM is needed before Medicare will even consider coverage, and patients over 65 have the greatest need for CGM due to their increased risk of severe hypoglycemia. Coverage must be a priority for the FDA in its considerations.
- Patient safety. CGM provides critical patient safety features including alarms, trend arrows, and remote monitoring. In addition, CGM offers a 30-40-fold increase in data (288 readings per day vs. 4-10 fingersticks), minimizing the frequency at which dirty hands affect readings. The dosing indication would also improve patient safety by allowing for the development of appropriate education programs for the thousands of patients who already use their CGM to dose insulin.
- Expanded use. An approved insulin-dosing claim could expand the number of people willing to use CGM (fewer fingersticks, less hassle) and the number of doctors willing to prescribe CGM (less difficult for their patients to use), which would improve health outcomes and the experience of daily glucose monitoring. Since diabetes requires constant attention and treatment, convenience and quality of life are critical in ensuring proper self-management.
- Future products. Approving Dexcom’s CGM for insulin dosing has implications for the regulation of future glucose sensors and will open the door for faster approval of new devices. This is key in driving innovation in diabetes care and accelerating the rate at which patients have access to valuable new tools.
In addition, this landmark dosing indication would reduce the daily psychological burden of diabetes self-management. As many of you know, I have lived with type 1 diabetes for nearly 30 years. Undetected hypoglycemia is a fear I live with every day. Through offering 24/7 access to glucose levels and trends, CGM lessens the menace of hypoglycemia and empowers patients to take action when needed. In fact, many people rely on CGM to survive, especially those with severe hypoglycemia and hypoglycemia unawareness.
To advocate for this important CGM indication and subsequent treatment implications, we at The diaTribe Foundation have composed a letter to the FDA urging the agency to keep patients’ perspectives at the forefront of its deliberation. We aim to collect 5,000 signatures on our letter by July 13, but the more support we can prove, the stronger our case. We need your help in achieving this goal!
Here’s what you can do:
- Help us make a difference by taking a moment to sign our letter to the FDA panel members. As the FDA conveyed, letters with the most names carry the most weight, particularly those from patients and their families. This letter has been reviewed by over a dozen scientists and advocates within the field, and it details the science behind the label update. I would be grateful to have you sign our letter and help us achieve our goal! You can read the full letter here, and sign it here.
- Share the importance of this issue with your networks. I would love to have you post our letter on social media to announce your support and spread the word. I have provided a sample Facebook post and tweets below that you can use as a starting point – please feel free to create your own as well! Our aim is to reach as many people possible and share the urgency of this issue.
Sample Facebook post: Sign this letter from diaTribe + friends if you believe that the FDA should approve Dexcom’s G5 CGM as a replacement for blood glucose meters for insulin dosing & making diabetes treatment decisions! www.diatribe.org/CGM
Sample tweet #1: Help advocate for #CGM + #PWD! Sign @diaTribeNews' letter by 7/13 to bring patient voices to @US_FDA: diatribe.org/CGM #DosewithCGM
For more information on how to get involved through writing to the FDA or requesting to speak at the open public hearing, please see our article on the meeting.