Safety Evaluation of the Omnipod® 5 Automated Insulin Delivery System Over Three Months of Use in Children With Type 1 Diabetes (T1D)

Advances in diabetes technology have transformed the treatment paradigm for T1D, yet the burden of the disease remains significant. The pediatric population poses unique challenges to glucose management with unpredictable exercise and food consumption. The Omnipod 5 System is a novel hybrid closed-loop (HCL) system with fully on-body operation. A tubeless insulin pump (pod) containing a personalized Model Predictive Control algorithm communicates directly with a Dexcom G6 continuous glucose monitor (CGM, or sensor) to automate insulin delivery. Therapy customization is enabled through glucose targets from 110–150 mg/dL, adjustable by time of day, which is a critical component to individualize glucose management in children. We report on the first, pivotal outpatient safety evaluation of the Omnipod 5 System in a large cohort of children with T1D. Participants aged 6–13.9y with T1D≥6 months and A1C Participants (N=112) were aged (mean±SD) 10.3±2.2y with T1D duration 4.7±2.6y and baseline A1C 7.7±0.9% (range 5.8–10.3%). TIR increased significantly from ST to HCL, from 52.5±15.6% to 68.0±8.1% (p180 mg/dL from 45.3±16.7% to 30.2±8.7% and ≥250 mg/dL from 19.1±13.1% to 9.6±5.4% (both p0.05). Mean glucose decreased from 183±32 to 160±15 mg/dL (p In this multi-center pivotal study in a large cohort of children with T1D, the Omnipod 5 System was safe and effective when used for 3 months at home. There were significant improvements in both TIR and A1C, while time below range (