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
Authors' conclusion
Glycemic outcomes with simplified bolusing were non-inferior to carbohydrate counting, suggesting carbohydrate counting ability should not affect AID access.
Study context
- Population
- Omnipod 5 automated insulin delivery (AID) users with T1D or T2D in the US, UK, France and Germany, 01/01/25–31/03/2592 % T1D
- Participants
- 195,529 participants
- Exposure
- Simplified meal bolusing vs carbohydrate counting
- Outcome
- Glycemic outcomes (TIR 70-180 mg/dL, TBR <70 mg/dL, mean glucose), non-inferiority of simplified bolusing vs carbohydrate counting
Methodological detailsreal-world data, non-inferiority, quantile regression, adjusted for user characteristics and device settings/usage
- Real-world data
- Non-inferiority
- Quantile regression, adjusted for user characteristics and device settings/usage
Main finding
As reported in the abstract
Difference in time in range (TIR) 70-180 mg/dL
2.5 % lower
Simplified bolusing
Difference in time below range (TBR) < 70 mg/dL
0.19 % lower
Simplified bolusing
Difference in mean glucose
5 mg/dL higher
Simplified bolusing
Observational data: associations, not effects.
Further findings
T2D: TIR 70-180 mg/dL, TBR <70 mg/dL and mean glucose, simplified bolusing vs carbohydrate counting
- Difference in TIR
- - 1.7 %
- Difference in TBR
- −0.05 %
- Difference in mean glucose
- + 4 mg/dL
- All met noninferiority
T1D subgroups by age group and country
- All endpoints met noninferiority, with similar findings across age groups and countries
Users with optimized settings and expected use patterns
- T1D maintained noninferiority
- T2D met noninferiority for TBR only
Original publication
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