Safety and Glycemic Outcomes with a Tubeless Automated Insulin Delivery System in Very Young Children with Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial

Objective: Very young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk of long-term complications and creating an immense management burden for caregivers. We conducted the first evaluation of the Omnipod® 5 Automated Insulin Delivery (AID) System in this population. Research Design and Methods: Eighty children aged 2-5.9 years used the investigational system in a single-arm study for 13 weeks following 14 days of baseline data collection with their usual therapy. Results: There were no episodes of severe hypoglycemia (SH) or diabetic ketoacidosis (DKA). By study end, HbA1c decreased by 0.55% (6.0mmol/mol) (p<0.0001). Time in target range of 70-180mg/dL (TIR) increased by 10.9%, or 2.6 hours/day (p<0.0001), while time <70mg/dL declined by median 0.27% (p=0.0204). Conclusions: Use of the AID system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase compared with baseline.