FDA Clears First OTC Glucose Monitor for Children

The US Food and Drug Administration (FDA) has cleared Dexcom Inc.'s Stelo Glucose Biosensor System for over-the-counter (OTC) use in children as young as 2 years who do not use insulin, establishing the first OTC continuous glucose monitor (CGM) indicated for a pediatric population.

According to the FDA’s June 12, 2026 announcement, the expanded clearance extends the indication to individuals 2 years and older, including children with diabetes managed with oral medications and those seeking to understand how diet and exercise affect glucose levels.

"Children deserve access to the best tools available to manage their health," said Michelle Tarver, MD, PhD, Director of the FDA's 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."

Stelo device design, sensor performance, and pediatric use considerations

The Stelo system consists of a wearable sensor paired with a compatible smartphone application, enabling continuous glucose measurement, recording, analysis, and display. The app updates glucose values every 15 minutes and supports use on a parent's or caregiver's device in addition to the child's own smartphone.

Each sensor is rated for up to 15 days of wear, though the FDA noted sensor wear time may run shorter in pediatric users than in adults due to interconnected physiological and behavioral factors. The device must be used under adult caregiver supervision for all pediatric patients.

The clearance relied in part on the FDA's use of real-world evidence (RWE), combining prior clinical study data from both pediatric and adult populations with real-world data on current integrated CGM (iCGM) use. This approach provided insight into expected device performance across the full 15-day wear period in younger users without requiring a dedicated pediatric trial.

Safety profile and contraindications for Stelo in children

In the prior clinical study referenced to support the clearance, participants reported mild adverse events including local infection, skin irritation, and pain or discomfort at the sensor site. The FDA noted no new safety signals were identified in the RWE analysis.

The system is not indicated for individuals with problematic hypoglycemia, as it does not issue low-glucose alerts. Stelo is also contraindicated for patients on dialysis. For patients with a personal history of disordered eating, consultation with a health care provider is recommended before use.

Health care providers should also be consulted before any medication adjustments are made based on the device's glucose output. The clearance aligns with the FDA's Home as a Health Care Hub Initiative, which advances patient-centered device development for use outside clinical settings.

The FDA identified pediatric prediabetes as a growing public health concern motivating the expanded indication, noting OTC CGMs can help younger users and their caregivers build glycemic awareness, track patterns in response to meals and activity, and support long-term health outcomes without a prescription barrier.

References

1. FDA. FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children. https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor-children. Published June 12, 2026. Accessed June 12, 2026.

2. Campbell P. FDA Clears Dexcom Stelo Sensor, First OTC Glucose Sensor in Agency History. Hcplive.com. Published March 5, 2024. Accessed June 12, 2026. https://www.hcplive.com/view/fda-clears-dexcom-stelo-sensor-first-otc-glucose-sensor-in-agency-history