Simplifying meal bolusing with Omnipod 5: real-world outcomes to support simplified user-initiated insulin dosing strategies in managing type 1 or type 2 diabetes.
TL;DR
Glycemic outcomes with simplified bolusing were non-inferior to carbohydrate counting, suggesting carbohydrate counting ability should not affect AID access.
Abstract
Aims
Automated insulin delivery (AID) systems typically require user‑initiated meal boluses. This study leveraged real-world data from Omnipod® 5 Automated Insulin Delivery System users to evaluate whether glycemic outcomes using simplified meal bolusing were non-inferior to carbohydrate counting.
Methods
A retrospective analysis of Omnipod 5 users in the US, UK, France, and Germany from 01/01/25 - 31/03/25 was conducted. Carbohydrate counting or simplified bolusing categorization was based on the proportion of boluses that used each individual's top five carbohydrate entries. The primary comparison used quantile regression and adjusted for users' characteristics and device settings/usage.
Results
The overall cohort included 195,529 individuals (92 % T1D). In T1D, simplified bolusing was associated with 2.5 % lower time in range (TIR) 70-180 mg/dL, 0.19 % lower time below range (TBR) < 70 mg/dL, and 5 mg/dL higher mean glucose compared with carbohydrate counting. All endpoints met noninferiority, with similar findings across age groups and countries. In T2D, differences were - 1.7 % for TIR, -0.05 % for TBR, and + 4 mg/dL for mean glucose, also meeting noninferiority. Among those using optimized settings and expected use patterns, T1D maintained noninferiority and T2D met noninferiority for TBR only.
Conclusions
Glycemic outcomes with simplified bolusing were non‑inferior to carbohydrate counting, suggesting carbohydrate counting ability should not affect AID access.