FDA approves first OTC CGM system

This could simplify the lives of diabetics living in the US

Image credit: Image Creator from Microsoft Designer/DALL.E and Canva

On March 5, the U.S. Food and Drug Administration (FDA) authorized the first over-the-counter continuous glucose monitor (CGM), the Dexcom Stelo Glucose Biosensor System, for individuals 18 and older not using insulin.

Here are a few key points:

• This device, which is not suitable for those with problematic hypoglycemia, aims to help users understand the effects of diet and exercise on blood sugar levels.

• It features a wearable sensor and smartphone app, displaying glucose readings every 15 minutes, with each sensor lasting up to 15 days.

• The FDA emphasizes that this clearance will increase health equity by making health monitoring more accessible.

• Clinical studies have shown its performance is comparable to other integrated CGMs, with some reported side effects like skin irritation and pain.

Image: Stelo Glucose Biosensor System. Credit: Dexcom.