FDA Approves First Over-the-Counter Continuous Glucose Monitor for Children with Diabetes, ETHealthworld
Bengaluru: The U.S. Food and Drug Administration said on Friday it has expanded the use of Dexcom’s Stelo Glucose Biosensor System to children with diabetes, making it the first over-the-counter continuous glucose monitor for pediatric use.
The device is cleared for patients aged two years and older who do not use insulin. The FDA had previously cleared Stelo for adults aged 18 and older in March 2024.
Stelo uses a wearable sensor and smartphone app to track glucose levels, showing readings and trends every 15 minutes. Each sensor can last up to 15 days, though wear time may be shorter in children, the FDA said.
The device can help children and caregivers understand how meals, exercise and lifestyle changes affect glucose levels, the agency said.
The FDA said children should use the device under adult supervision, and users should consult a healthcare provider before changing medication based on its readings.
The device is not meant for people with problematic low blood sugar, as it is not designed to alert users about that potentially dangerous condition.
(Reporting by Kunal Das in Bengaluru)
