Dexcom Stelo cleared as first OTC continuous glucose monitor for children

The US Food and Drug Administration (FDA) has cleared Dexcom's Stelo Glucose Biosensor System as the first over-the-counter continuous glucose monitor (CGM) for children, expanding the integrated CGM to people 2 years of age and older who do not use insulin.¹

The clearance extends an authorization the FDA first granted in March 2024, when Stelo became the first glucose biosensor cleared without a prescription for adults 18 years and older.² The agency framed the pediatric action as a response to rising rates of prediabetes among US children, which place millions at risk of progressing to type 2 diabetes. Dexcom positions the device for pediatric users who manage their condition with oral medication and for those tracking how diet, exercise, and lifestyle affect glucose.

"Children deserve access to the best tools available to manage their health," said Michelle Tarver, MD, PhD, director of the FDA Center for Devices and Radiological Health. "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."

Understanding Stelo’s FDA clearance in children

The Stelo Glucose Biosensor System is an integrated CGM (iCGM) indicated for people 2 years of age and older who do not use insulin, including children with diabetes managed on oral medication. A wearable sensor pairs with an application on a compatible smartphone or other smart device, including a parent's or caregiver's phone, to continuously measure, record, and display glucose values. The app refreshes glucose measurements and trends every 15 minutes.

According to Dexcom, each sensor lasts up to 15 days, though wear time may run shorter in pediatric users than in adults because of physiological and behavioral factors.

The FDA based the pediatric clearance on real-world evidence rather than a new pivotal trial. Dexcom and the agency drew on prior clinical study data from pediatric and adult populations, combined with real-world data on current iCGM use, to model expected device performance in children across the full 15-day wear period. The agency cited the action as an example of real-world evidence supporting regulatory decision-making.¹

Stelo safety profile and use limitations in pediatric patients

Participants in the prior clinical study reported mild adverse events, including local infection, skin irritation, and pain or discomfort.¹ The FDA paired the clearance with several use limitations relevant to pediatric and adult users alike.

Stelo is not intended for people with problematic hypoglycemia, because the system is not designed to alert users when a dangerously low blood sugar occurs. The device is also not appropriate for people on dialysis. People with a history of disordered eating or eating disorders should consult a health care provider before use.

For children, the device should be used under the supervision of an adult caregiver. Users and caregivers should consult a health care provider before making any medication adjustments based on the device output. The clearance aligns with the FDA's Home as a Health Care Hub Initiative, which advances patient-centered devices designed for daily use at home.

References

1. US Food and Drug Administration. FDA clears first over-the-counter continuous glucose monitor for children. Published June 12, 2026. Accessed June 12, 2026. https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor-children

2. DexCom, Inc. Stelo by Dexcom first glucose biosensor to be cleared by FDA as over-the-counter. Published March 5, 2024. Accessed June 12, 2026. https://investors.dexcom.com/news/news-details/2024/Stelo-by-Dexcom-First-Glucose-Biosensor-to-be-Cleared-by-FDA-as-Over-the-Counter/default.aspx