The US Food and Drug Administration (FDA) has cleared Dexcom’s Stelo glucose biosensor system for children, making it the first over-the-counter (OTC) continuous glucose monitor (CGM) for paediatric prediabetic and diabetic patients to be cleared by the agency.
Dexcom’s Stelo, an integrated CGM (iCGM), is now indicated for use in children two years of age and older who do not use insulin, expanding the iCGMs initial FDA clearance for individuals age 18 and above in March 2024.
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At this time, no other OTC CGM is available in the paediatric population, with other such FDA-approved offerings, including Abbott’s Lingo and Libre CGM, currently only indicated in patients aged 18 and above, as of their market clearance in June 2024.
Stelo is a wearable sensor that gets paired with an app to continuously measure, record, analyse, and display glucose values, with each sensor lasting for up to 15 days before needing to be replaced.
The FDA highlighted that the expanded indication clearance for Stelo represented an example of the agency’s use of real-world evidence (RWE) to support regulatory decision-making. The agency’s remarks refer to a guidance document and notification it issued in December 2025 around removing limitations on the use of real-world evidence (RWE), clearing the way for de-identified data to be used for medical device submissions.
In the case of Dexcom, the company worked alongside the FDA, evaluating a combination of previous clinical study data from paediatric and adult diabetes patients, along with RWE in the form of real-world data on current iCGM use among both groups, to understand expected device performance in paediatric users over Stelo’s full 15-day wear period.
Regarding Stelo’s marketing expansion, the FDA highlighted the impact of prediabetes in children. This condition is characterised by higher-than-normal blood sugar levels, though not high enough to classify as a type 2 diabetes diagnosis. The agency said that the availability of real-time glucose data can help paediatric patients and their caregivers better manage and understand glucose levels.
The global CGM market is projected to reach a valuation of $15.69bn in 2035, as per GlobalData analysis.
Michelle Tarver, director at the FDA’s Center for Devices and Radiological Health (CDRH), commented that children deserve access to the best tools available to manage their health. The FDA’s clearance for Dexcom’s Stelo in paediatric populations reflects the agency’s “commitment to fostering innovation” for paediatric patients, Tarver continued, adding that the clearance supports the “safe and effective use of medical devices where children live, learn, and play”.
A GlobalData market model reveals that Dexcom held a CGM market share of 44.7% in the US in 2025, second only to Abbott in pole position with a 48.5% share. However, in territories including Europe, the Asia Pacific (APAC) region and the Middle East & Africa (MEA), Dexcom’s market share is dwarfed by leader Abbott.
