June 2026 brought two separate FDA decisions that, together, represent a meaningful shift in how children with Type 1 diabetes can be monitored and treated.
On June 12, the FDA cleared the Dexcom Stelo continuous glucose monitor (CGM) for over-the-counter use in children as young as 2 years old — the first OTC CGM ever cleared for a pediatric population. And also on June 12, the FDA granted accelerated approval to teplizumab (Tzield; Sanofi) for a new indication: slowing the loss of insulin production in children and adolescents aged 8 to 17 who were recently diagnosed with Stage 3 Type 1 diabetes.
