Introduction: In people with T2D (PwT2D) whose glycemic control with non-insulin glucose-lowering drugs (GLDs) is not at goal, progression to insulin therapy can be delayed or dose titration infrequent, which may result in a higher likelihood of complications.1 Small feasibility studies have, recently, demonstrated safe and effective automated insulin delivery (AID) use in PwT2D.2,3 Herein, we report the preliminary safety and glycemic outcomes of a large T2D cohort using MiniMed™ AHCL.
Methods: A 13-site, single-arm, study had 95 PwT2D (mean±SD age of 60.3±10.8 years and 18.6±8.6 years T2D duration) who underwent a run-in period (~21 days) of open-loop or HCL therapy followed by a study period (~90 days) of AHCL therapy. Insulin-using participants on ≥1 non-insulin GLD at baseline included MDI (N=41/58); CSII or SAP (N=20/30); and HCL (N=6/7). Severe hypoglycemia (SH), diabetic ketoacidosis (DKA), metrics of glycemic control and insulin delivery were assessed.
Results: There were no episodes of SH or DKA during the run-in or study period. A1C, mean SG and TAR were significantly reduced, with AHCL use (Table). TITR, TIR and TDD were significantly increased, with no significant change in weight.
Conclusion: These findings show that MiniMed™ AHCL is safe and can significantly improve T2D dysglycemia. Future analyses will assess baseline factors that predict better T2D glycemic control.
A. Bhargava: Research Support; Medtronic, Lilly Diabetes, Novo Nordisk, Abbott, Pfizer Inc., Boehringer-Ingelheim, Dexcom, Inc., Tandem Diabetes Care, Inc., Akero Therapeutics, Inc., Biomea Fusion, Inc., Madrigal Pharmaceuticals, Inc., Carmot Therapeutics, Inc. J. Thrasher: Advisory Panel; Medtronic. Board Member; Medtronic. Research Support; Medtronic. Speaker's Bureau; Medtronic. Research Support; Eli Lilly and Company, Novo Nordisk. Speaker's Bureau; Bayer Inc. B.W. Bode: Research Support; Omnipod. Speaker's Bureau; Omnipod. Research Support; Medtronic. Advisory Panel; Medtronic. 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. R.M. Bergenstal: Other Relationship; Abbott. Research Support; Arkray Marketing. Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur. Other Relationship; Dexcom, Inc., Eli Lilly and Company. Consultant; embecta, Hygieia. Research Support; Insulet Corporation. Consultant; MannKind Corporation. Other Relationship; Medtronic, Novo Nordisk. Consultant; Onduo LLC, Roche Diabetes Care. Other Relationship; Sanofi. Research Support; Tandem Diabetes Care, Inc. Other Relationship; UnitedHealth Group. Consultant; Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S. M. Dempsey: Research Support; Eli Lilly and Company, Novo Nordisk A/S, Inversago Pharma, Medtronic. J.H. Reed: None. H. Ma: None. A. Keiter: None. T.L. Cordero: Employee; Medtronic. J. McVean: Employee; Medtronic. J. Shin: None. A.S. Rhinehart: Employee; Medtronic. Stock/Shareholder; Medtronic. R.A. Vigersky: Employee; Medtronic.