FDA clears first OTC continuous glucose monitor for children aged 2 and up

On June 12, 2026, the U.S. Food and Drug Administration cleared the first over-the-counter continuous glucose monitor for children.

The decision extends Dexcom’s Stelo Glucose Biosensor System to people two years and older who do not use insulin.

Stelo is an integrated continuous glucose monitor the FDA had already allowed on the market without a prescription for adults 18 and over in March 2024.

With this new clearance, the same device can now be used by children, including those with diabetes treated with oral drugs, and by people who simply want to see how food, exercise, and daily routines affect their glucose levels.

The move comes as prediabetes in children is becoming more common in the United States, putting millions of young people at higher risk for type 2 diabetes.

For the FDA, making CGMs available over the counter is one way to give families more tools to follow glucose patterns in children who are not on insulin but still need closer monitoring.

Stelo uses a small sensor worn on the body and an app on a compatible smartphone or other smart device, such as a parent’s phone.

The sensor continuously measures glucose and sends data to the app, which shows values and trends about every 15 minutes.

Each sensor is designed to stay in place for up to 15 days before it has to be replaced, although in children the actual wear time may be shorter because of normal activity and other factors.

The FDA still tells users and caregivers not to change medication on their own and to talk with a health care provider before adjusting any treatment based on the numbers from the device.

To support the clearance, Dexcom and the agency combined results from earlier clinical studies in adults and children with real-world data from people already using similar integrated CGM systems.

That information helped regulators understand how Stelo is expected to perform in children over the full wear period.

In previous studies, the most common side effects were mild problems at the insertion site, such as local infection, skin irritation, or pain and discomfort.

For pediatric use, the FDA stresses that an adult caregiver should always supervise the child.

The system is not meant for people with problematic hypoglycemia, because it does not send alerts when blood sugar drops too low, and it is also not intended for patients on dialysis.

People with a history of disordered eating or eating disorders are advised to discuss the device with a health care professional before starting to use it.

The agency also points to this decision as an example of using real-world evidence in regulatory work and links it to its Home as a Health Care Hub Initiative, which promotes medical devices that fit into everyday life at home.

Additional information Product : Stelo Glucose Biosensor System (Dexcom Inc.).

Who it is for : People 2 years and older who do not use insulin, including children with diabetes on oral medication and people who want to track how lifestyle affects glucose.

How it works : Wearable sensor plus smartphone or smart device app, with glucose data and trends updated around every 15 minutes.

Wear time : Up to 15 days per sensor, possibly shorter for children.

Safety notes : Use in children should be supervised by an adult; the device is not for people with problematic hypoglycemia or on dialysis.

Frequently asked questions Can families change a child’s medication only based on Stelo readings? No. The FDA recommends talking with a health care professional before making any changes in treatment. Is Stelo suitable for every child with diabetes? No. It is not intended for children with problematic hypoglycemia or those on dialysis, and it should always be used under adult supervision. Glossary Continuous glucose monitor (CGM) : Device that tracks glucose around the clock using a small sensor on the body. Integrated CGM (iCGM) : CGM designed to work together with other digital health tools and devices. Prediabetes : Higher-than-normal blood glucose that has not yet reached the level of diabetes and is linked to a greater risk of type 2 diabetes. Real-world evidence (RWE) : Evidence based on data collected in routine care rather than in traditional randomized clinical trials.

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