The FDA has cleared the first over-the-counter continuous glucose monitor for children, Dexcom's Stelo system, for ages 2 and older not using insulin. - The device provides real-time glucose readings every 15 minutes via a wearable sensor and smartphone app.
- It is intended for children with diabetes on oral medications or those monitoring lifestyle effects on glucose. - The approval was supported by real-world evidence from clinical studies in both pediatric and adult populations.
- The system is not for individuals with problematic hypoglycemia or those on dialysis, and requires adult supervision for children. This clearance aims to address rising prediabetes rates in children and improve glycemic awareness and long-term health outcomes.