Introduction and Objective: MiniMedTM 780G (MM780G) advanced hybrid closed loop (AHCL) therapy with the Guardian™ 4 sensor demonstrated significantly improved A1C, increased time in range (%TIR, 70-180mg/dL) and tight range (%TITR, 70-140mg/dL), with no increase in time below range (%TBR, <70mg/dL), in PwT2D.1 Herein, we report on system use with the new, disposable, all-in-one Simplera SyncTM sensor.Methods: A single-arm trial (31 sites) evaluated MM780G+Simplera use in an intention-to-treat cohort of 236 (aged 59.7±11.2 years, 19.3±9.8 years T2D duration). Participants underwent a run-in period (~21 days) of open-loop or HCL before entering a study period of AHCL use (~90 days). Non-insulin glucose-lowering drugs were to remain stable. Safety outcomes were recorded and glycemic metrics and insulin delivery during baseline/run-in and study were compared.Results: With AHCL, mean A1C was reduced from 7.7% to 6.9% (p<0.0001), %TIR and %TITR were increased to 84.9% (p<0.0001) and 58.1% (p<0.0001), respectively, and %TBR remained 0.3% (Table). Mean total daily insulin, of which 65% was automated, increased by 14.5U and weight by 0.7kg. There was 1 severe hypoglycemia and 1 DKA event, unrelated to device, during AHCL use.Conclusion: MiniMed™ 780G system use with the Simplera SyncTM sensor far exceeds ADA glycemic targets for PwT2D, while decreasing burden, as a majority of insulin is delivered automatically.
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. J. Thrasher: Advisory Panel; Medtronic. Board Member; Medtronic. Consultant; Medtronic. Research Support; Medtronic, AstraZeneca, Merck & Co., Inc, Novo Nordisk, Lilly Diabetes, Inversago Pharma. A. Bhargava: Research Support; Amgen Inc, Endogenex, Gasherbrum Bio, Inc, vTv Therapeutics, Boehringer-Ingelheim, Abbott, AbbVie Inc, Dexcom, Inc., Eli Lilly and Company, Madrigal Pharmaceuticals, Inc, Medtronic, Novo Nordisk, MannKind Corporation, Carmot Therapeutics, Inc, Akero Therapeutics, Inc, 89bio, Inc, Viking Therapeutics, Zydus Lifesciences, Kowa Company, Ltd. Consultant; Verdiva Bio. Research Support; Covance, Quintiles, PPD, Barbara Davis Center for Diabetes. D.C. Klonoff: Consultant; Synchneuro, Thirdwayv, Tingo, Afon, embecta, Glucotrack, Lifecare, Novo Nordisk, Samsung. L. Poretsky: None. 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. J.H. Reed: None. L.K. Billings: Advisory Panel; Novo Nordisk, Eli Lilly and Company, Sanofi. Consultant; Dexcom, Inc. Advisory Panel; Bayer Pharmaceuticals, Inc. Consultant; Xeris Pharmaceuticals, Inc. Advisory Panel; Amgen Inc. Consultant; Pfizer Inc. T.S. Bailey: Consultant; Ypsomed AG, i-Sense. Research Support; LifePlus, Abbott Diagnostics, Biolinq, Corcept Therapeutics, Dexcom, Inc., Eli Lilly and Company, Medtronic. Consultant; Medtronic. Research Support; Novo Nordisk. Consultant; Novo Nordisk, Sanofi. Research Support; Senseonics, vTv Therapeutics. Consultant; Abbott, Abbott Diagnostics, ACON, CeQur, HagarTech, MannKind Corporation, Perspirion, Sequel Med Tech. P.K. Piper: Research Support; Medtronic, Biomea Fusion, Rhythm Pharmaceuticals, Inc. P.F. Mora: None. C. Jacobson: None. R.M. Bergenstal: Advisory Panel; Abbott. Research Support; Abbott. Consultant; Abbott. Research Support; Dexcom, Inc. Consultant; Dexcom, Inc., Eli Lilly and Company. Research Support; Eli Lilly and Company. Consultant; Novo Nordisk. Research Support; Novo Nordisk. Consultant; Roche Diabetes Care, Sanofi, Medtronic. Research Support; Medtronic, Insulet Corporation, Hemsley Charitable Trust. Other Relationship; MannKind Corporation. Consultant; Medscape. Research Support; National Institute of Diabetes and Digestive and Kidney Diseases, Tandem Diabetes Care, Inc, UnitedHealth Group. Consultant; Vertex Pharmaceuticals Incorporated, Ascensia Diabetes Care, American Diabetes Association, Hygieia, embecta, Senseonics, Zealand Pharma A/S. B.W. Bode: Research Support; Lilly USA LLC, Biomea Fusion, Abbott, Abvance Therapeutics, Carmot Therapeutics, Inc. Advisory Panel; Beta Bionics, Inc. Research Support; Medtronic. Speaker’s Bureau; Sanofi, IQVIA Inc. Advisory Panel; Vertex Pharmaceuticals Incorporated. Research Support; CeQur. D. Ahn: Speaker’s Bureau; Abbott, Lilly Diabetes. Advisory Panel; Lilly Diabetes. Speaker’s Bureau; Xeris Pharmaceuticals, Inc, Ascensia Diabetes Care, Sequel Med Tech, MannKind Corporation, Insulet Corporation, Novo Nordisk. Consultant; Honey Health. S. Lee: Research Support; Metronics, MannKind Corporation. 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. Lender: None. F.E. Broyles: None. A. Manessis: None. D.I. Shulman: Advisory Panel; Medtronic. M. Dempsey: Research Support; Lilly USA LLC, Novo Nordisk, Medtronic. H. Ma: None. A. Keiter: None. J. Shin: Employee; Medtronic. M. Dworak: Employee; Medtronic. J.J. McVean: Employee; Medtronic. A.S. Rhinehart: Employee; Medtronic. Stock/Shareholder; Medtronic. R.A. Vigersky: Employee; Medtronic.
Medtronic Diabetes
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