First over-the-counter CGM cleared for marketing
The integrated continuous glucose monitor (CGM) is intended for anyone ages 18 years and older who does not use insulin.
On March 5, the FDA cleared the first over-the-counter continuous glucose monitor (CGM) for marketing.
The Dexcom Stelo Glucose Biosensor System, an integrated CGM, is intended for anyone at least 18 years of age who does not use insulin, including those with diabetes treated with oral medications or those without diabetes who want to better understand how diet and exercise affect their glucose levels. The FDA stressed that the system is not intended for those with problematic hypoglycemia because it is not designed to alert users to this potentially dangerous condition. The system uses a wearable sensor that displays glucose values and trends every 15 minutes via an app on the user's smartphone or other smart device. The sensor is placed in the skin and can be worn for 15 days before replacement.