Overview
- The U.S. Food and Drug Administration expanded clearance of Dexcom’s Stelo integrated continuous glucose monitor to people aged 2 years and older who do not use insulin and to non‑diabetic users seeking metabolic insights.
- Stelo is a small sensor worn on the back of the upper arm that sends glucose readings to a smartphone every 15 minutes and is designed for up to 15 days of wear, though pediatric wear time may be shorter.
- The pediatric clearance relied on Dexcom’s prior clinical study data plus real‑world evidence from current CGM users, reflecting the FDA’s growing use of real‑world data in device decisions.
- The agency set safety limits and user guidance: Stelo is not intended for people with problematic hypoglycemia or those on dialysis, it does not provide low‑glucose alerts, children should be supervised by a caregiver, and clinicians should be consulted before changing medications.
- The OTC authorization could broaden access for families without prescription coverage, offer real‑time data to help address rising pediatric prediabetes, and comes as Dexcom plans app feature upgrades for non‑insulin users later this summer.