The U.S. Food and Drug Administration (FDA) has cleared the first over-the-counter continuous glucose monitor (CGM) designed specifically for children, marking a significant step in pediatric diabetes management.
On June 13, 2026, the agency approved Dexcom Inc.'s Stelo Glucose Biosensor System for children aged two years and older who do not use insulin. This follows the FDA's earlier clearance of the same device for adults 18 and over in March 2024.
The Stelo system is a wearable sensor paired with a smartphone app that continuously measures, records, and displays glucose levels every 15 minutes. It is intended for children with diabetes who manage their condition with oral medications, as well as for those who want to understand how diet and exercise affect their glucose levels.
The device is not designed for individuals with problematic hypoglycemia or those on dialysis, and it should be used under adult supervision for pediatric users.
Dr. Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, emphasized the importance of providing children with advanced health tools.
"Children deserve access to the best tools available to manage their health," she said. "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."
The FDA's decision was supported by real-world evidence from previous clinical studies involving both pediatric and adult participants. The sensor lasts up to 15 days, though wear time may be shorter in children due to physiological and behavioral factors.
Mild adverse events reported include local infection, skin irritation, and pain or discomfort. Users and caregivers are advised to consult healthcare providers before making medication adjustments based on the device's readings.
This approval addresses the growing prevalence of prediabetes among U.S. children, which places millions at risk for developing Type 2 diabetes.
By providing real-time glucose data, the Stelo system aims to help pediatric patients and their families build glycemic awareness, track patterns, and make informed lifestyle changes for better long-term health outcomes.