FDA extends Stelo OTC CGM to children ages 2 and up: access wider, clinical scope unchanged
On June 12, 2026, the FDA cleared the Dexcom Stelo Glucose Biosensor System for over-the-counter use by people ages two and older who do not use insulin, expanding the original March 2024 adult clearance to pediatric users. The hardware is the same: a 15-day wearable sensor delivering 15-minute glucose readings via smartphone, with adults required as caregivers for child users. The clearance is an access decision, not a shift in evidence: the label excludes insulin-dependent users and does not endorse Stelo as a long-term health monitor for metabolically healthy children. The buyer logic that applied to adults, a short-window audit rather than an open subscription, applies at least as much here.