1904-LB: Glycemic Improvement with Use of the Omnipod 5 Automated Insulin Delivery System in Adults with Type 2 Diabetes—Results of the SECURE-T2D Pivotal Trial

Background: There is limited experience with automated insulin delivery (AID) in Type 2 Diabetes (T2D). Methods: We conducted a multicenter pivotal clinical trial to evaluate use of the Omnipod 5 AID System in a large diverse group of adults with T2D in the US. Adults aged 18-75y with T2D using insulin (basal-bolus, premix, or basal-only) who had screening HbA1c <12.0% were enrolled. Non-insulin agents were continued throughout. After a 14-day standard therapy phase to capture baseline glycemic management, participants initiated 13 weeks of AID. The primary endpoint was change in HbA1c from baseline to 13 weeks. Study completion occurred on March 1, 2024. Results: A total of 305 adults with T2D (mean age 57±11 years, 24% Black, 22% Hispanic/Latino) were enrolled in the study and initiated AID. Basal-bolus insulin delivery was being used by 79%, basal-only by 21%, GLP-1 receptor analogs by 55%, and SGLT1 or 2 inhibitors by 44%. Following 13 weeks of Omnipod 5 use, HbA1c decreased from 8.2±1.3% at baseline to 7.4±0.9% at study end (treatment effect= -0.8%, 95% CI: -1.0 to -0.7, p<0.001). The benefit of AID was greatest in those with the highest baseline HbA1c (Figure). Conclusion: These pivotal trial results demonstrate the substantial benefit of the Omnipod 5 AID System in a large diverse group of adults with T2D. Clinical trial registration: NCT05815342 Disclosure F.J. Pasquel: Research Support; Tandem Diabetes Care, Inc., Insulet Corporation, Dexcom, Inc., Ideal Medical Technologies, Novo Nordisk. Consultant; Dexcom, Inc., Medscape. G. Davis: Research Support; Insulet Corporation. Consultant; Medscape. A.L. Peters: Advisory Panel; Lilly Diabetes, Vertex Pharmaceuticals Incorporated, Medscape. Research Support; Abbott, Insulet Corporation. J.C. Parker: Speaker's Bureau; Novo Nordisk, Corcept Therapeutics, Insulet Corporation. L.M. Laffel: Consultant; Dexcom, Inc. Advisory Panel; Medscape, Medtronic, Vertex Pharmaceuticals Incorporated. Consultant; Novo Nordisk. Advisory Panel; Lilly Diabetes, Provention Bio, Inc., Sanofi-Aventis U.S., Janssen Pharmaceuticals, Inc., MannKind Corporation. J. Mathew: None. K.N. Castorino: Research Support; Abbott, Dexcom, Inc. Speaker's Bureau; Dexcom, Inc. Research Support; Lilly Diabetes, Medtronic, MannKind Corporation, Insulet Corporation. Consultant; Medscape. D.F. Kruger: Advisory Panel; Abbott. Research Support; Beta Bionics, Inc., Carmot Therapeutics, Inc. Speaker's Bureau; Dexcom, Inc. Advisory Panel; Dexcom, Inc., Lilly Diabetes. Speaker's Bureau; Lilly Diabetes. Advisory Panel; Insulet Corporation. Research Support; Insulet Corporation. Advisory Panel; MannKind Corporation, Novo Nordisk. Speaker's Bureau; Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Provention Bio, Inc. Speaker's Bureau; Sanofi, Xeris Pharmaceuticals, Inc. Advisory Panel; Pendulum Therapeutics. Research Support; Tandem Diabetes Care, Inc. Advisory Panel; Cequr. Speaker's Bureau; Cequr. Advisory Panel; Medtronic, embecta, Ascensia Diabetes Care. Research Support; Abbott. Advisory Panel; Sanofi. K.M. Dungan: Advisory Panel; Eli Lilly and Company, Dexcom, Inc. Research Support; Dexcom, Inc. Advisory Panel; Elsevier. Research Support; Abbott, ViaCyte, Inc., Sanofi, Omnipod. Advisory Panel; Omnipod. Other Relationship; Up-To-Date. Speaker's Bureau; Med Learning Group, Medscape, Cardiometabolic Health Congress. Consultant; Oppenheimer & Co. Speaker's Bureau; Integritas. M. Kipnes: None. E. Jauch: Research Support; Insulet Corporation. T. Oser: Research Support; Abbott. Advisory Panel; Medscape. Consultant; Dexcom, Inc. Research Support; Insulet Corporation. V.N. Shah: Consultant; Dexcom, Inc., Insulet Corporation. Research Support; Insulet Corporation. Advisory Panel; Novo Nordisk. Research Support; Novo Nordisk. Advisory Panel; Sanofi, Medscape. Consultant; embecta, Tandem Diabetes Care, Inc. B. Horowitz: Speaker's Bureau; Eli Lilly and Company, Novo Nordisk. Consultant; AbbVie Inc. Research Support; Insulet Corporation, Bayer Inc. A.L. Carlson: Research Support; Medtronic, Insulet Corporation, Tandem Diabetes Care, Inc., Eli Lilly and Company, Sanofi. Other Relationship; Novo Nordisk. Advisory Panel; MannKind Corporation. Research Support; Dexcom, Inc. M.L. Warren: Research Support; Novo Nordisk, Insulet Corporation. Speaker's Bureau; Lilly Diabetes. Advisory Panel; Lilly Diabetes. Research Support; AstraZeneca, Bayer Inc. Speaker's Bureau; Bayer Inc. Research Support; AbbVie Inc., Medtronic, Ascendis Pharma A/S, Amolyt. Speaker's Bureau; Ascendis Pharma A/S, Amgen Inc. Research Support; AstraZeneca. Advisory Panel; Hygieia. W. Deeb: None. J.B. Buse: Other Relationship; Novo Nordisk. Consultant; Corcept Therapeutics. Research Support; Corcept Therapeutics, Dexcom, Inc., Insulet Corporation. Consultant; Alkahest, Anji Pharmaceuticals, Aqua Medical, Altimmune Inc., AstraZeneca, Boehringer-Ingelheim, CeQur, Eli Lilly and Company, embecta, GentiBio, Glyscend Inc., Mellitus Health, Metsera, Pendulum Therapeutics, Praetego, LLC, Stability Health, Terns Pharmaceuticals, Insulet Corporation, Vertex Pharmaceuticals Incorporated, vTv Therapeutics. Other Relationship; Medtronic. Stock/Shareholder; Glyscend Inc., Mellitus Health, Pendulum Therapeutics, Praetego, LLC, Stability Health. J.H. Reed: None. J. Berner: None. T. Blevins: Research Support; Arrowhead Pharmaceuticals, Inc., Insulet Corporation. Advisory Panel; Insulet Corporation. Research Support; Tandem Diabetes Care, Inc., Medtronic. Other Relationship; Medtronic. Advisory Panel; MannKind Corporation. Research Support; MannKind Corporation. Speaker's Bureau; AstraZeneca. Research Support; Lilly Diabetes. Speaker's Bureau; Lilly Diabetes. Research Support; Novo Nordisk. Speaker's Bureau; Novo Nordisk. Research Support; Boehringer-Ingelheim. Speaker's Bureau; Boehringer-Ingelheim. Research Support; Dexcom, Inc., Abbott Diagnostics, ViaCyte, Inc., Amgen Inc., Carmot Therapeutics, Inc. Other Relationship; Nanjing AscendRare Pharmaceutical Technology. C. Bajaj: Consultant; Dexcom, Inc., Lilly Diabetes. C. Kollman: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc., Juvenile Diabetes Research Foundation (JDRF), Insulet Corporation, MannKind Corporation. D. Raghinaru: None. T.T. Ly: Employee; Insulet Corporation. R.W. Beck: Consultant; Insulet Corporation. Research Support; Insulet Corporation. Consultant; Tandem Diabetes Care, Inc. Research Support; Tandem Diabetes Care, Inc. Consultant; Beta Bionics, Inc. Research Support; Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc. Consultant; Novo Nordisk. Research Support; Novo Nordisk, Eli Lilly and Company. Consultant; embecta, Vertex Pharmaceuticals Incorporated, Hagar, Ypsomed AG, Sanofi, Zucara Therapeutics, Sequel. Funding This study was funded by Insulet Corporation.