By: IPP Bureau
Last updated : June 16, 2026 9:11 am
Expanded indication makes Stelo the first FDA-cleared OTC CGM for children aged two years and older with diabetes or prediabetes
Dexcom has received clearance from the US Food and Drug Administration (FDA) to expand the use of its Stelo continuous glucose monitoring (CGM) system to children aged two years and older, making it the first over-the-counter CGM approved for pediatric patients with diabetes or prediabetes.
The expanded indication builds on Stelo’s original FDA clearance in March 2024 for adults aged 18 years and above. With the latest approval, Dexcom becomes the first company to offer an OTC CGM solution for children, a segment where no other non-prescription CGM devices are currently available. Competing products, including Abbott’s Lingo and Libre CGM systems, remain approved only for adult use.
Stelo is an integrated CGM system consisting of a wearable sensor paired with a mobile application that continuously measures, records, analyzes, and displays glucose levels in real time. Each sensor can be worn for up to 15 days before replacement.
The FDA highlighted the approval as an example of how real-world evidence (RWE) is increasingly being used to support regulatory decision-making. Dexcom collaborated with the agency by combining data from previous clinical studies involving both adult and pediatric diabetes patients with real-world data from current CGM users. This approach helped evaluate the device’s performance in children throughout the full wear period.
The agency noted that the approval could have a significant impact on pediatric prediabetes management. Prediabetes, characterized by elevated blood glucose levels that are not yet high enough to be classified as type 2 diabetes, is becoming an increasing concern among children and adolescents. Access to real-time glucose data may help young patients and their caregivers better understand glucose patterns and make informed lifestyle and health decisions.
Michelle Tarver, Director of the FDA’s Center for Devices and Radiological Health (CDRH), said children deserve access to advanced tools that help them manage their health effectively.
Tarver noted that the clearance reflects the agency’s commitment to supporting innovation for pediatric patients and promoting the safe and effective use of medical devices in everyday environments.