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U.S. Clears First Over-the-Counter Continuous Glucose Monitor for Children, Lowering Stelo’s Eligible Age to 2
The FDA has cleared Dexcom’s Stelo Glucose Biosensor System for expanded over-the-counter use by people aged 2 and older who are not using insulin, bringing children into the scope of OTC continuous glucose monitoring in the United States for the first time; however, the device is not suitable for all people with diabetes, and clinical interpretation and follow-up care still require caution.
The U.S. Food and Drug Administration (FDA) has cleared Dexcom’s Stelo Glucose Biosensor System for expanded over-the-counter use, for people aged 2 and older who are not using insulin. This makes Stelo the first over-the-counter continuous glucose monitor (CGM) in the United States that can be used by children.
Stelo had previously been cleared in 2024 for over-the-counter use by adults. This expansion of the eligible age range indicates that, for specific populations and under specific conditions of use, U.S. regulators consider that some blood glucose monitoring technologies can enter broader everyday health management settings without a prescription.
Continuous glucose monitors typically use sensors to track changes in glucose in interstitial fluid beneath the skin, allowing users to see glucose trends rather than only a single fingertip blood sample reading. For people who are not using insulin, such devices may help them understand the relationship between diet, activity, and glucose fluctuations, but they are not diagnostic tools and cannot replace medical evaluation.
The FDA said the review of this pediatric indication used existing clinical data and real-world evidence. This point is noteworthy because, in recent years, medical device regulation has placed increasing emphasis on the complementary relationship between postmarket data, real-world use experience, and traditional clinical research.
However, publicly available information remains limited. This clearance does not mean that all children need to use continuous glucose monitoring, nor does it mean the device can be used by people using insulin or in situations requiring real-time treatment decisions. Interpreting children’s glucose involves growth, diet, illness status, and the care environment. If there are concerns about diabetes or metabolic health, assessment by healthcare professionals is still needed.
The impact of this decision may fall on two levels at the same time: first, diabetes and metabolic health technology moving from medical institutions into homes and everyday management; and second, how the FDA uses real-world evidence in pediatric populations to support expanded device indications. The former involves accessibility and health literacy, while the latter relates to evidence standards and long-term safety monitoring.
For parents and caregivers, over-the-counter access lowers the threshold for use, but it also increases the responsibility to understand the data correctly. Glucose curves may provide useful clues, but they may also cause unnecessary anxiety; how to translate data into appropriate action will be an issue that must be faced as this type of pediatric health technology becomes more widely adopted.