FDA clears first over-the-counter glucose monitor for children

The US Food and Drug Administration has expanded approval of Dexcom's (DXCM) Stelo Glucose Biosensor System to include children with diabetes, making it the first over-the-counter continuous glucose monitor cleared for pediatric use.

The device is now authorized for patients aged two and older who do not use insulin. The FDA had previously cleared Stelo for adults aged 18 and over in March 2024.

Stelo relies on a wearable sensor paired with a smartphone app to track glucose levels, providing readings and trend data every 15 minutes. Each sensor lasts up to 15 days, though the FDA noted that wear time may be shorter in children. The agency said the device can help young patients and their caregivers understand how meals, exercise and other lifestyle factors affect glucose levels.

The FDA stipulated that children should use the device under adult supervision, and that users should consult a healthcare provider before adjusting medication based on its readings. The device is not designed for people prone to dangerously low blood sugar, as it does not alert users to that condition.