FDA clears first OTC continuous glucose monitor for children

FDA has cleared Stelo Glucose Biosensor System, an over-the-counter continuous glucose monitor (CGM), for children aged 2 years and older who do not use insulin. The device, previously available OTC only for adults, is the first prescription-free CGM approved for pediatric use.

The clearance expands access to continuous glucose monitoring for children with type 2 diabetes managed without insulin, as well as those with prediabetes or families interested in understanding how diet, exercise, and other lifestyle factors affect glucose levels.

Stelo uses a wearable sensor paired with a smartphone application to continuously measure glucose and display values and trends every 15 minutes. The system can also be linked to a parent's or caregiver's smartphone, allowing adults to monitor glucose data remotely. Each sensor is designed to last up to 15 days, although wear time may be shorter in children.

Clinicians should note that Stelo is not intended for children who use insulin, have problematic hypoglycemia, or receive dialysis. FDA also recommends that individuals with a history of disordered eating discuss use of the device with a healthcare professional before starting monitoring.

Users and caregivers should be advised to consult a healthcare provider before making medication changes based on CGM readings. Reported adverse events were generally mild and included local infection, skin irritation, and discomfort at the sensor site.

The clearance was supported by clinical study data and real-world evidence evaluating device performance in both adult and pediatric users.

Source: FDA. 2026 June 12. [Press release]. FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children