FDA OKs Dexcom’s Stelo Over-the-Counter CGM for Children

The U.S. Food and Drug Administration (FDA) has cleared the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom’s Stelo glucose biosensor system.

The integrated CGM (iCGM) is indicated for people two years and older who don’t use insulin. The FDA previously cleared Stelo for people 18 years and older in March 2024.

Stelo uses a wearable sensor paired with an app installed on a compatible smartphone or other smart device, such as a parent’s or caregiver’s smartphone, to continuously measure, record, analyze, and display glucose values. Each sensor lasts up to 15 days before replacement, however, the agency advised sensor wear time might be shorter in pediatric users than adults due to several physiological and behavioral factors. The app displays glucose measurements and trends every 15 minutes.

The FDA used real-world evidence (RWE) to support this clearance. Dexcom and the FDA used previous clinical study data from pediatrics and adults, along with RWE derived from real-world data on current iCGM users among both groups, to understand expected device performance in pediatric users over the 15-day wear period.

The agency advised that Stelo should be used under an adult caregiver’s supervision. The system isn’t for people with problematic hypoglycemia because it’s not designed to alert users when this potentially dangerous condition occurs. The system is also not for dialysis, and those with a history of disordered eating or eating disorders should speak with their healthcare provider before using Stelo.

“Children deserve access to the best tools available to manage their health,” said Center for Devices and Radiological Health director Michelle Tarver, MD, Ph.D. “Today’s clearance reflects the FDA’s commitment to fostering innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn, and play.”