P-258: Real-World performance of a tubeless automated insulin delivery system in children and adolescents with type 1 diabetes: evidence from international markets
F Campbell, V Cherubini, A Clement-de Boers, D Deiss, S Johnson, N Lind, K Perge, A -K Tuomaala, D Do, I Hadjiyianni, T LyAbstract
Introduction
The Omnipod® 5 Automated Insulin Delivery (AID) System delivers personalized insulin therapy through customizable glucose targets ranging from 110–150 mg/dL in 10 mg/dL increments. The system is indicated for use in people aged ≥2 years with type 1 diabetes (T1D) and is commercially available in several international markets.
Objectives
This study assessed the real-world performance of the system among children and adolescents with T1D across Europe, Australia, and Canada.
Methods
A retrospective analysis of CGM and insulin data from Omnipod 5 users in Europe, Australia, and Canada with T1D aged 2 to <18y whose guardian provided consent at onboarding was conducted for those with sufficient CGM data (≥90 days of data, ≥75% of days with ≥220 readings) as of January 15, 2026. Glycemic outcomes were evaluated for users overall and for those utilizing optimized system settings (Target Glucose: 110 mg/dL [6.1 mmol/L]; correction factor: ≤1500/total daily insulin (TDI) (mg/dL; ≤83/TDI [mmol/L]); insulin to carb ratio: ≤350/TDI; time in Automated Mode: ≥90%; boluses/day: ≥3).
Results
Data from 44,332 users meeting the inclusion criteria were included in the analysis (median age: 10y). Overall, users achieved a median time in range (TIR; 70-180 mg/dL [3.9-10.0 mmol/L]) of 65%. Among those (n=1,652) utilizing optimized system settings, users achieved a median TIR of 73% and low time below range (median time <70 mg/dL [<3.9 mmol/L] was 1.7%) with minor variability in glycemic outcomes across countries (Figure).
Conclusions
Collectively, these real-world results in >44,300 pediatric Omnipod 5 users with T1D demonstrate consistent glycemic benefits with AID use across a large and regionally diverse population, particularly among those using optimized settings.