U.S. FDA: CGM Low BG Alarms
The FDA has mandated that CGM LOW BG alarms MAY NOT be turned off or silenced.
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.
- 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!
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.
U.S. INSULIN Act
The Congressional Diabetes Caucus introduced the “Improving Needed Safeguards for Users of Lifesaving Insulin Now” (INSULIN) Act.
The bill includes the following:
- Eliminates deductibles
- Caps insulin copays at $35 per product per month or 25% list price – whichever is lower.
- Bans health plan utilization management tools (such as prior authorization or step therapy)
- Blocks pharmacy benefit managers (PBMs) from negotiating rebates on covered insulins for which the manufacturer has reduced the list price.