FDA Clears Dexcom Stelo as First Over-the-Counter Continuous Glucose Monitor for Children Aged 2 and Older
Key Insights
The FDA expanded marketing clearance for the Dexcom Stelo Glucose Biosensor System (search) to children aged 2 years and older who do not use insulin.
Stelo becomes the first over-the-counter continuous glucose monitor available for pediatric use in the United States.
The wearable device provides glucose readings every 15 minutes via a smartphone app and is designed for up to 15 days of use per sensor.
The U.S. Food and Drug Administration has expanded marketing clearance for the Dexcom Stelo Glucose Biosensor System (search) to include children aged 2 years and older, making it the first over-the-counter continuous glucose monitor (CGM) available for pediatric use in the United States. The announcement, made on June 12, builds on the device's initial FDA clearance for adults aged 18 and older in March 2024.
The integrated CGM is indicated for adults and children, including those with diabetes (search), who do not take insulin but may use oral medication to manage their condition. The over-the-counter device may also be used by adults, as well as children and their caregivers, to monitor glucose levels for dietary, exercise, and other lifestyle reasons.
Device Features and Usage
The Stelo Glucose Biosensor System is a wearable sensor that pairs with an application on a smart device, updating glucose data every 15 minutes to help users measure, record, and analyze glucose levels. Each sensor is designed to last up to 15 days before requiring replacement, though the FDA noted that wear time may be shorter in children.
According to the FDA, "these devices can help pediatric patients and their caregivers build greater glycemic awareness, track patterns in response to meals and exercise, and make informed adjustments to support healthier long-term outcomes and quality of life."
Safety Considerations and Limitations
The FDA emphasized that children should use the device under adult supervision, and users should consult a healthcare provider before changing medication based on its readings. Importantly, the device is not intended for people with problematic low blood sugar, as it is not designed to alert users about that potentially dangerous condition.
The expanded clearance represents a significant step in broadening access to glucose monitoring technology for younger populations who do not require insulin therapy, offering families a tool to better understand how lifestyle factors influence glucose levels without the need for a prescription.