Abstract
To examine the efficacy and safety of the tubeless Omnipod 5 automated insulin delivery (AID) system compared with pump therapy with a continuous glucose monitor (CGM) in adults with type 1 diabetes with suboptimal glycemic outcomes. RESEARCH DESIGN AND METHODS In this 13-week multicenter, parallel-group, randomized controlled trial performed in the U.S. and France, adults aged 18–70 years with type 1 diabetes and HbA1c 7–11% (53–97 mmol/mol) were randomly assigned (2:1) to intervention (tubeless AID) or control (pump therapy with CGM) following a 2-week standard therapy period. The primary outcome was a treatment group comparison of time in range (TIR) (70–180 mg/dL) during the trial period. RESULTS A total of 194 participants were randomized, with 132 assigned to the intervention and 62 to the control. TIR during the trial was 4.2h/day higher in the intervention compared with the control group (mean difference 17.5% [95% CI 14.0%, 21.1%]; P < 0.0001). The intervention group had a greater reduction in HbA1c from baseline compared with the control group (mean ± SD 21.24 ± 0.75% [213.6 ± 8.2 mmol/mol] vs. 20.68 ± 0.93% [27.4 ± 10.2 mmol/mol], respectively; P < 0.0001), accompanied by a significantly lower time <70 mg/dL (1.18 ± 0.86% vs. 1.75 ± 1.68%; P = 0.005) and >180 mg/dL (37.6 ± 11.4% vs. 54.5 ± 15.4%; P < 0.0001). All primary and secondary outcomes weremet. No instances of diabetes-related ketoacidosis or severe hypoglycemia occurred in the intervention group. CONCLUSIONS Use of the tubeless AID system led to improved glycemic outcomes compared with pump therapy with CGMamong adults with type 1 diabetes, underscoring the clinical benefit of AID and bolstering recommendations to establish AID systems as preferred therapy for this population.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 2248-2257 |
| Number of pages | 10 |
| Journal | Diabetes care |
| Volume | 47 |
| Issue number | 12 |
| DOIs | |
| State | Published - Dec 2024 |
Funding
The authors extend their sincere thanks to the study participants and their families. The authors thank Dr. Jodi Bernstein of Jodi Bernstein Medical Writing, who received payment from Insulet Corporation for creating the data tables and supplement and the writing of the first draft of the manuscript, and the Insulet clinical team, including Bonnie Dumais, Anna Busby, Amna Soomro, Anny Caruso, Michaela Sorrell, Tanya Meletlides, Krista Kleve, Jill Cernohous, Abigail Murphy, Robert Shaw, Becky Estabrook, and Alice Bonin, for contributions to the conduct of the study. The authors also thank the dedicated staff at each clinical site who made this study possible. This study was funded by Insulet Corporation.
ASJC Scopus subject areas
- Internal Medicine
- Endocrinology, Diabetes and Metabolism
- Advanced and Specialized Nursing
