Settings Associated with Optimal Glycemic Outcomes with the Omnipod® 5 Automated Insulin Delivery System: Evidence...

Identifying programmable device settings and user behaviors associated with achieving glycemic targets is critical for informing clinical practice and improving outcomes with automated insulin delivery (AID) systems. This real-world analysis aimed to identify predictors of achieving optimal glycemic outcomes for people with type 1 diabetes (T1D) using the Omnipod^® 5 AID System.

This retrospective analysis included real-world data from Omnipod 5 users aged ≥ 2 years with T1D in the United States and Europe who had sufficient continuous glucose monitor data (≥30 days with ≥1 reading; ≥75% of days with ≥220 readings) available in Insulet's device and person-reported datasets between January 1 and March 31, 2025. Logistic regression was used to identify programmable settings and user behaviors associated with achieving >70% time in range (TIR; 70-180 mg/dL [3.9-10.0 mmol/L]). Optimal thresholds for the top modifiable predictors were determined using Youden's J statistic, and their impact on glycemic outcomes was explored.

Data from 176,405 users were analyzed. Predictors of achieving >70% TIR included the following: a higher number of user-initiated boluses/day, greater time in Automated Mode, use of lower glucose targets, and a more aggressive correction factor (CF) and insulin-to-carbohydrate (I:C) ratio (all P < 0.001). Use of optimized device settings (110 mg/dL [6.1 mmol/L] target, I:C ratio ≤350/total daily insulin dose [TDD], and CF ≤1500/TDD [mg/dL] or ≤83/TDD [mmol/L]) with user behaviors that reflect expected system use (≥90% time in Automated Mode, ≥3 boluses/day), used by 7.9% and 1.4% of adult and pediatric users, respectively, resulted in a higher median TIR compared with users overall (77% vs. 66% in adult and 78% vs. 62% in pediatric users, respectively), and time spent in hypoglycemia remained low across age groups. Findings were consistent across geographic regions and prior insulin regimen.

These results provide actionable guidance for clinicians to optimize outcomes for people with T1D using the Omnipod 5 System.