From one of the founders of the #WeAreNotWaiting” movement: “Hey FDA, if you had been listening to us, we wouldn’t have had to overwhelm you with public comments!”
This is about the Fulfillment of 21st Century Cures Act Section 3060 Required Report: Comments from People with Insulin-Requiring Diabetes, which affects all people with diabetes and their technology. Here’s another chance to tell them, in a few short sentences, what you want, regarding CGM (continuous glucose monitoring) alarms! The FDA has mandated that CGM LOW BG alarms MAY NOT be turned off or silenced. I guess they don’t trust us to manage our own diabetes.
Comments are due at 11:59 pm ET on 15 August 2022, to provide comments on FDA changes to the way CGM display and alarm systems are regulated. This has implications for remote monitoring and automated insulin delivery systems, both commercial and DIY.
We request your assistance in helping the FDA and device providers (FDA considers software for treatment of disease to be a device) understand the benefits of real-time CGM access and the risks we carry by not having ubiquitous real-time access to our diabetes device data.
We hope you will choose to spend a moment to add your voice to the #WeAreNotWaiting chorus. Under categories, choose Device Industry – C0012.
Here’s the link: https://www.regulations.gov/commenton/FDA-2018-N-1910-0047
Here is some suggested text that we encourage you to use to personalize with specific examples/context for how and where access to CGM data from you or a loved one would be helpful in reducing the burden of living with insulin-requiring diabetes.
“Our family lives with type 1 diabetes. We benefit from remote monitoring and display of CGM glucose values. Please let CGM manufacturers know that we rely on secondary displays and would like to be able to access our data directly from our smartphones.”
In addition, Dexcom, Abbott, and other CGM manufacturers may be unwilling to create secure, real-time data access for end users (that’s us) or their designees, for fear of running afoul of the FDA during review of future devices (such as the Dexcom G7). We encourage FDA to provide clarity that enabling such access is approved and in fact improves safety and reduces risk.