ConexiantFDA Expands OTC CGM Access to Children

📋 Regulatory Action / Label Change

The FDA has cleared the Dexcom Stelo, an OTC continuous glucose monitor, for children ages 2 and older not using insulin, extending access to a device previously limited to adults since March 2024. The clearance covers children with diabetes managed by oral medication and those whose caregivers want visibility into how diet and activity affect glucose levels.

Professional Impact

• The Stelo pairs a wearable sensor with a smartphone app, delivering glucose readings and trend data every 15 minutes to the patient’s or caregiver’s device; each sensor lasts up to 15 days, though wear time may be shorter in pediatric patients.
• Clearance was supported by pediatric and adult clinical study data plus real-world CGM evidence; the FDA did not require new dedicated pediatric trials.
• The device carries three explicit contraindications for pediatric use: problematic hypoglycemia (no low-glucose alerts), dialysis dependence, and history of disordered eating without prior HCP consultation.
• Pediatric use requires adult caregiver supervision; the app’s caregiver-device compatibility directly supports this requirement.

Action Items

• Counsel families that Stelo does not alert for hypoglycemia. Clinicians should screen for hypoglycemia history before recommending.
• Screen adolescent patients for disordered eating history before OTC CGM discussion, per FDA guidance.
• Document that Stelo is not indicated for insulin-using patients; reinforce distinction from prescription CGM systems in patient education.