As there is a pressing need for better treatment options for type 2 diabetes (T2D) , it is crucial to explore new technologies such as automated insulin delivery (AID) in this population. Little is known about how successful these systems will be in T2D, especially over a longer duration of use. The safety and practicability of the Omnipod 5 AID System in adults with T2D was previously demonstrated during an 8-week outpatient feasibility trial. Those completing this initial study were invited to continue system use for an additional 26 weeks to assess longer-term efficacy. We present results from the first 13-week follow-up assessment of the extension study. In the initial study, adults with T2D (A1C >8%) previously on either basal-only (n=12) or basal-bolus insulin injections (n=12) , with or without CGM, used AID for 8 weeks following 14 days of their standard therapy. Those participating in the extension study continued AID use, and A1C was measured again after 13 weeks (21 weeks of total AID use) . Efficacy was assessed by change in A1C from baseline. Most participants (N=22, 92%) continued into the extension phase. Two of these participants had completed the initial study before the extension study was available but were allowed to re-join, resulting in a 2-4-month return to their standard therapy before resuming AID. Participants were aged (mean±SD) 61±8y with BMI 33.9±4.4kg/m2, diabetes duration 19±9y, and baseline A1C 9.4±0.9% (range: 8.1-11.7%) . Mean A1C decreased to 8.0±0.7% after 8 weeks of AID (p<0.05) . After an additional 13 weeks of use, mean A1C was 7.7±0.7%, corresponding to an overall decrease of 1.6±1.0% from baseline to 21 weeks of total use (p<0.05) . There were no episodes of severe hypoglycemia during the study. The continued improvement in A1C with longer duration of AID use with the Omnipod 5 System demonstrates a durable and clinically meaningful benefit for participants with previously sub-optimal glycemic control outcomes on injection insulin therapy.
G.M.Davis: Consultant; Medscape, Research Support; Insulet Corporation. A.L.Peters: Advisory Panel; Abbott Diabetes, AstraZeneca, Eli Lilly and Company, Novo Nordisk, Shouti, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Other Relationship; Omada Health, Inc., Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Leona M. and Harry B. Helmsley Charitable Trust, Stock/Shareholder; Teladoc Health. B.W.Bode: Advisory Panel; CeQur SA, MannKind Corporation, Medtronic, Novo Nordisk, Zealand Pharma A/S, Consultant; Bigfoot Biomedical, Inc., Research Support; Abbott, Beta Bionics, Inc., Dexcom, Inc., Diasome, Dompé, Eli Lilly and Company, Insulet Corporation, IQVIA Inc., Jaeb Center for Health Research, Medtronic, Novo Nordisk, Provention Bio, Inc., REMD Biotherapeutics, Sanvita Medical, Senseonics, ViaCyte, Inc., Speaker's Bureau; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Xeris Pharmaceuticals, Inc., Stock/Shareholder; AgaMatrix, Glytec, LLC. A.L.Carlson: Advisory Panel; MannKind Corporation, Employee; Bright Health Group, Other Relationship; Medtronic, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi, UnitedHealth Group. B.Dumais: Employee; Insulet Corporation. T.Vienneau: Employee; Insulet Corporation, Stock/Shareholder; Dexcom, Inc., GlaxoSmithKline plc., Insulet Corporation. L.M.Huyett: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation. T.T.Ly: Employee; Insulet Corporation, Stock/Shareholder; Insulet Corporation.
This study was funded by Insulet Corporation.