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Clinical Trial
. 2025 Jan;27(1):143-154.
doi: 10.1111/dom.15993. Epub 2024 Oct 9.

Glycaemic outcomes in adults with type 2 diabetes over 34 weeks with the Omnipod® 5 Automated Insulin Delivery System

Georgia M Davis  1 , Anne L Peters  2 , Bruce W Bode  3 , Anders L Carlson  4 , Bonnie Dumais  5 , Todd E Vienneau  5 , Lauren M Huyett  5 , Trang T Ly  5
Affiliations
Clinical Trial

Glycaemic outcomes in adults with type 2 diabetes over 34 weeks with the Omnipod® 5 Automated Insulin Delivery System

Georgia M Davis et al. Diabetes Obes Metab. 2025 Jan.

Abstract

Aims: The aim was to evaluate the effect of extended use of the Omnipod® 5 Automated Insulin Delivery (AID) System in adults with type 2 diabetes and suboptimal glycaemic control.

Materials and methods: Following an 8-week single-arm, multicentre, outpatient trial of AID in adults with type 2 diabetes and baseline HbA1c ≥ 8% (≥ 64 mmol/mol), participants were given the opportunity to continue use of the AID system in a 26-week (~6 month) extension phase. The primary safety endpoints were percentage of time with sensor glucose ≥ 250 mg/dL and < 54 mg/dL. Additional glycaemic measures, including percentage of time in range (TIR) (70-180 mg/dL) and HbA1c, were evaluated. The use of non-insulin anti-hyperglycaemic medications was permitted throughout the entire study.

Results: During the initial 8-week study, participants (N = 22) achieved a decrease in percentage of time ≥ 250 mg/dL from 27.4% ± 21.0% to 10.5% ± 8.8% (p < 0.0001), which further decreased to 9.7% ± 9.2% during the extension phase (p = 0.0002 vs. standard therapy). Percentage of time < 54 mg/dL remained low from standard therapy through extension (median [interquartile range] 0.00% [0.00%, 0.06%] vs. 0.02% [0.00%, 0.05%], p > 0.05). HbA1c decreased by 1.6% ± 1.2% (15.5 ± 13.1 mmol/mol, p < 0.0001) and TIR increased by 22.4% ± 19.2% (p < 0.0001) from standard therapy through extension with no significant change in body mass index and without an observed increase in total daily insulin requirements.

Conclusions: These longer-term findings of Omnipod 5 AID System use demonstrate the potential value of AID in helping people with type 2 diabetes reach glycaemic targets.

Keywords: GLP‐1; SGLT‐2 inhibitor; clinical trial; insulin pump therapy; type 2 diabetes.

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Conflict of interest statement

Georgia M. Davis reports research support from Insulet and has served as a consultant for Medscape. Anne L. Peters served on an advisory board for Medscape and Vertex. Anne L. Peters has received research support from Insulet and Abbott Diabetes Care. She has stock options in Omada Health. Bruce W. Bode reports research support from Insulet during the conduct of the study, as well as research support from Abbott, Advance, Diasome, Dexcom, Janssen, Lilly, Medtronic, Novo Nordisk, Provention Bio, Sanofi, Sanvita, Senseonics, REMD Biotherapeutics, Xeris and vTv Therapeutics. Bruce W. Bode reports consultant and speaking fees from Boehringer Ingelheim, Insulet, Lilly, Mannkind, Medtronic, Novo Nordisk, Sanofi, Senseonics, Sanofi, Xeris and Zealand. Anders L. Carlson is an advisory board member, has received consulting fees and has spoken for Mannkind, Medtronic and Sanofi. Anders L. Carlson reports research support from Insulet, Dexcom, Medtronic, Abbott, Sanofi, Lilly, Novo Nordisk and UnitedHealth. Anders L. Carlson is an employee of the International Diabetes Center at Park Nicollet. Bonnie Dumais, Todd E. Vienneau, Lauren M. Huyett and Trang T. Ly are full‐time employees of and own stock in Insulet Corporation..

Figures

FIGURE 1
FIGURE 1
Mean HbA1c at baseline, 8‐week automated insulin delivery (AID) phase and extension phase. Results are shown stratified by prior therapy (panel A) by group A: prior basal‐bolus injections and group B: prior basal‐only injections, as well as stratified by other medication use (panel B) for those using or not using glucagon‐like peptide‐1 (GLP‐1) receptor agonists or sodium glucose cotransporter‐2 (SGLT‐2) inhibitors. Error bars show the standard deviation. The HbA1c at each follow‐up time point (8, 21 and 34 weeks) was significantly different from baseline for all groups (p < 0.05).
See this image and copyright information in PMC

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