The U.S. Food and Drug Administration has cleared the first over-the-counter continuous glucose monitor for children as young as two who do not use insulin. The device was previously authorized for adults in March 2024.
“Children deserve access to the best tools available to manage their health,” said Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health. “Today’s clearance reflects the FDA’s commitment to fostering innovation for paediatric patients.”
Prediabetes affects millions of American children, heightening their risk for Type 2 diabetes. The new over-the-counter CGM provides real-time glucose data, helping families track how meals, exercise, and daily routines impact blood sugar levels and make informed lifestyle adjustments.
The device consists of a wearable sensor that pairs with a smartphone app, displaying glucose readings every 15 minutes. Each sensor can be worn for up to 15 days, though wear time may be shorter in children. The FDA advises consulting a healthcare provider before making any medication changes based on the device’s output.