Introduction and Objective: The SECURE-T2D pivotal trial recently demonstrated safety and efficacy of the Omnipod® 5 Automated Insulin Delivery (AID) System in adults with insulin-treated T2D. This sub-analysis evaluated outcomes in participants previously using basal without bolus insulin.Methods: This multicenter 305-participant single-arm trial enrolled 63 participants with T2D using basal without bolus insulin (mean age 55±11y, 27% Black, 22% Hispanic/Latino, 71% using GLP-1 RA at study entry). After a 14-day standard therapy (ST) phase, participants initiated 13 weeks of AID.Results: A1C decreased by mean (95% CI) 1.2% (0.9%, 1.5%), from 8.6±1.2% at baseline to 7.5±0.8% at study end (p<0.001). Time in range (70-180 mg/dL) increased overall and among those using or not using a GLP-1 RA with AID (Figure). Robust mean time <70 mg/dL was 0.1±0.1% for both ST and AID and was similar in those using and not using GLP-1 RA. Total daily insulin was reduced by 6.3U/day (p=0.04) and weight increased by 0.9kg (p=0.03), with similar changes observed between users and non-users of GLP-1 RA.Conclusion: This cohort of adults with T2D using basal without bolus insulin and not meeting glycemic targets successfully initiated AID, demonstrating the feasibility to bypass initiation of MDI and transition directly to AID in clinical practice.
A.L. Carlson: Research Support; Abbott, Amgen Inc, Dexcom, Inc., Eli Lilly and Company, Hemsley Charitable Trust, Insulet Corporation. Other Relationship; Medtronic, Novo Nordisk, Tandem Diabetes Care, Inc. Research Support; Sanofi. Advisory Panel; MannKind Corporation. F.J. Pasquel: Consultant; Insulet Corporation. Research Support; Novo Nordisk, Dexcom, Inc., Ideal Medical Technologies, Tandem Diabetes Care, Inc, Insulet Corporation. Consultant; Dexcom, Inc. G.M. Davis: Research Support; Insulet Corporation. D.M. Huffman: None. A.L. Peters: Advisory Panel; Medscape. Consultant; Vertex Pharmaceuticals Incorporated. Research Support; Insulet Corporation, Abbott. Other Relationship; Omada Health. J.C. Parker: Speaker’s Bureau; Corcept Therapeutics, Novo Nordisk, Insulet Corporation. L.M. Laffel: Advisory Panel; Boehringer-Ingelheim, Sanofi, MannKind Corporation, Medtronic, Vertex Pharmaceuticals Incorporated, Tandem Diabetes Care, Inc, Insulet Corporation. Research Support; Dexcom, Inc. Advisory Panel; Sequel Med Tech. Other Relationship; Janssen Pharmaceuticals, Inc. Consultant; Arbor Biotech. G. Romeo: None. J. Mathew: None. K.N. Castorino: Research Support; Abbott, Medtronic, Dexcom, Inc., Lilly Diabetes, MannKind Corporation, Eli Lilly and Company, Insulet Corporation. Speaker’s Bureau; Dexcom, Inc. Advisory Panel; MannKind Corporation. Speaker’s Bureau; Insulet Corporation. D.F. Kruger: Other Relationship; Abbott. Advisory Panel; embecta, MannKind Corporation. Other Relationship; CeQur, Tandem Diabetes Care, Inc, Dexcom, Inc. Research Support; Jaeb Center for Health Research. Other Relationship; Eli Lilly and Company. Advisory Panel; Structure Therapeutics, Inc. Other Relationship; Insulet Corporation, Sequel Med Tech. Advisory Panel; Corcept Therapeutics. K.M. Dungan: Research Support; Abbott Diagnostics, Dexcom, Inc. Consultant; Dexcom, Inc. Other Relationship; UpToDate. Consultant; Oppenheimer & Co. Advisory Panel; Insulet Corporation. Research Support; Insulet Corporation. Board Member; Elsevier, Eli Lilly and Company. Speaker’s Bureau; Medscape, Med Learning Group, Impact Education. M. Kipnes: Research Support; Zydus Lifesciences, Zucara Therapeutics, 89bio, Inc, Abbott Diagnostics, AbbVie Inc, Akero Therapeutics, Inc, Amgen Inc, Biomea Fusion, Boehringer-Ingelheim, Biolinq, MannKind Corporation, Eli Lilly and Company, Carmot Therapeutics, Inc, Endogenex, Ionis Pharmaceuticals, Novo Nordisk, Corcept Therapeutics, Insulet Corporation, Fractyl Health, Inc. Advisory Panel; Corcept Therapeutics, AP stem. Other Relationship; Jaeb Center for Health Research. Research Support; Sinocare Inc, Kowa Pharmaceuticals America, Inc, Diamyd. E. Jauch: Research Support; Carmot Therapeutics, Inc, Omnipod. T. Oser: Consultant; Dexcom, Inc. Research Support; Abbott, Insulet Corporation, Dexcom, Inc. Advisory Panel; Medscape. V.N. Shah: Consultant; Dexcom, Inc. Advisory Panel; Sanofi, Novo Nordisk. Consultant; Lilly Diabetes. Advisory Panel; embecta. Consultant; Insulet Corporation. Advisory Panel; Tandem Diabetes Care, Inc, Ascensia Diabetes Care. Research Support; Enable Bioscience. Consultant; Genomelink and Lumosfit. B. Horowitz: Advisory Panel; AbbVie Inc. Research Support; AbbVie Inc. Speaker’s Bureau; Eli Lilly and Company. Research Support; Eli Lilly and Company. Speaker’s Bureau; Novo Nordisk. Research Support; Novo Nordisk. Speaker’s Bureau; Tandem Diabetes Care, Inc. M.L. Warren: Research Support; Medtronic, Insulet Corporation, Abbott. Speaker’s Bureau; Lilly Diabetes. Research Support; Lilly USA LLC, Amgen Inc. Speaker’s Bureau; Amgen Inc. Advisory Panel; Lilly USA LLC. Research Support; Diasome Pharmaceuticals, Bayer Pharmaceuticals, Inc, Ascendis Pharma A/S, Novo Nordisk. W. Deeb: None. J.B. Buse: Other Relationship; Corcept Therapeutics, Dexcom, Inc., Novo Nordisk. Consultant; Altimmune Inc, Amgen Inc, ApStem, Aqua Medical, AstraZeneca, Boehringer-Ingelheim, CeQur, Eli Lilly and Company, embecta, GentiBio. Other Relationship; Glyscend Therapeutics. Consultant; Insulet Corporation, Medtronic. Other Relationship; Mellitus Health. Consultant; Metsera. Other Relationship; Pendulum Therapeutics, Praetego, Stability Health. Consultant; Tandem Diabetes Care, Inc, TERNS Pharmaceuticals, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S. J.H. Reed: None. J. Berner: None. T. Blevins: Research Support; Lilly Diabetes. Speaker’s Bureau; Lilly Diabetes. Research Support; Abbott, Boehringer-Ingelheim. Speaker’s Bureau; Boehringer-Ingelheim. Research Support; Novo Nordisk. Speaker’s Bureau; Novo Nordisk. Research Support; Dexcom, Inc. Speaker’s Bureau; Dexcom, Inc. Research Support; Insulet Corporation. Advisory Panel; Insulet Corporation. Research Support; Medtronic, MannKind Corporation. Advisory Panel; MannKind Corporation. Research Support; Tandem Diabetes Care, Inc, AstraZeneca. Speaker’s Bureau; Sanofi-Aventis U.S. Research Support; Merck & Co., Inc, Amgen Inc, Roche Diabetes Care, AbbVie Inc, Viking Therapeutics, Structure Therapeutics, Inc. C. Bajaj: Speaker’s Bureau; Dexcom, Inc., Lilly Diabetes. Research Support; Insulet Corporation, Novo Nordisk, Lilly Diabetes, AbbVie Inc, Arrowhead Pharmaceuticals, Inc. C. Kollman: Research Support; Dexcom, Inc., Insulet Corporation, MannKind Corporation, Breakthrough T1D (formerly JDRF), Capillary Biomedical, Inc, Hemsley Charitable Trust, National Institute of Diabetes and Digestive and Kidney Diseases, Tandem Diabetes Care, Inc. L. Kanapka: None. T.T. Ly: Employee; Insulet Corporation. Stock/Shareholder; Insulet Corporation. R.W. Beck: Research Support; Insulet Corporation. Consultant; Insulet Corporation. Research Support; Tandem Diabetes Care, Inc, Beta Bionics, Inc, Dexcom, Inc., Bigfoot Biomedical, Inc, Abbott, embecta, Sequel Med Tech, MannKind Corporation. Consultant; Novo Nordisk, Vertex Pharmaceuticals Incorporated, Hagar, Ypsomed AG, Zucara Therapeutics, Abata Therapeutics, Eli Lilly and Company.
This study was funded by Insulet Corporation.
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