News Flash from Loop and Learn

URGENT DEADLINE:  15 August 2022 at Midnight ET
FDA Comment Period is ending for changes to the way CGM display and alarms are regulated

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#WeAreNotWaiting Needs Your HELP!

The FDA has mandated that CGM LOW BG alarms MAY NOT be turned off or silenced. This has implications for remote monitoring and automated insulin delivery systems, both commercial and DIY.

What if you are in a business meeting? Theatre? Classroom? People may choose not to use CGM because the alerts are NOT under our control. Teens should NOT be embarrassed by a screaming CGM. Employees should NOT be shamed or face reprimand from bosses, etc.

Instructions:

• Tap on link: tinyurl.com/ct6n22ft
• Fill in the comment box with your message
• Select a Comment Category: Device Industry C0012
• Enter your email
• Tell about yourself: choose either Individual or Anonymous
• Check the box that you have read/understood
• Tap the GREEN Submit button
• THAT'S IT! All in under 3 minutes!

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. It seems that they don’t trust insulin-requiring diabetics to manage their own diabetes.

We hope you will choose to spend a moment to add your voice to the #WeAreNotWaiting chorus. 

Here is some sample language, but please personalize with specific examples/context on the importance of being able to manage your CGM alarms in order to reduce 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 and their alarms. However, not being able to turn off CGM alarms may result in having to remove the CGM altogether for certain student testing situations [or important business meetings, legal proceedings, etc.], which will NOT improve health and safety”

The FDA thinks they should force this issue. We know that we should have the right to control our own devices, our own data and our alarms/alerts.