— Authorization of Stelo integrated CGM extends to children without diabetes as well
June 15, 2026
• 2 min read
The FDA cleared the first over-the-counter (OTC) integrated continuous glucose monitor (CGM) for children 2 years and older with or without diabetes, the agency announced on Friday.
The Stelo Glucose Biosensor System device is indicated for children with diabetes who do not use insulin but instead manage their condition with oral medication, as well as those without diabetes who want to understand how diet, exercise, and other lifestyle changes affect their blood sugar levels.
