1901-LB: Safety and Glycemic Outcomes Using the MiniMed 780G System with a Disposable All-in-One Sensor with Transmitter

Objective: The present study assessed impact of the MiniMed™ 780G (MM780G) advanced hybrid closed-loop (AHCL) system on glycemic metrics and safety when used with the disposable all-in-one Simplera Sync™ sensor*. Methods: Youths (aged 7-17yrs) and adults (aged 18-80yrs) with T1D were enrolled in a single-arm study (24 U.S. sites) with a ~2-week run-in where HCL (Auto Basal only) or open-loop delivery was used. This was followed by a three-month study period with AHCL activated. Glycemic outcomes and insulin delivered during the last 6-7 weeks of the study, in which system settings were optimized at investigator’s discretion, were compared to those of the run-in. Impact of recommended optimal settings (ROS, 100 mg/dL glucose target GT with a 2hr active insulin time AIT), was explored. Results: All groups showed significantly increased TIR and TITR and significantly reduced TAR, compared to run-in (Table). Use of ROS further improved TIR, TITR and TAR, in part, due to 60% automated basal and bolus delivery. No episodes of device-related severe hypoglycemia or DKA occurred. Conclusion: Use of the MM780G with the Simplera Sync™ sensor was safe and demonstrated improved glycemic outcomes, compared with run-in, and compared to glycemic outcomes of the pivotal trials1,2. Similarly, a lower GT and shorter AIT were associated with a further increased TIR and reduced TAR and, here, an increased TITR. Disclosure G.P. Forlenza: Research Support; Abbott, Dexcom, Inc. Consultant; Dexcom, Inc. Research Support; Insulet Corporation. Consultant; Insulet Corporation. Research Support; Medtronic. Advisory Panel; Medtronic. Research Support; Tandem Diabetes Care, Inc. Consultant; Tandem Diabetes Care, Inc. S.A. MacLeish: Speaker's Bureau; Insulet Corporation. Advisory Panel; Prevention Bio. D.I. Shulman: Advisory Panel; Medtronic. Research Support; Medtronic. S. Accacha: Speaker's Bureau; Azurity. S.K. Garg: Research Support; Eli Lilly and Company. Advisory Panel; Medtronic. Research Support; Medtronic. Advisory Panel; Novo Nordisk. Research Support; DarioHealth Corp., Dexcom, Inc., Diasome. Advisory Panel; Roche Diabetes Care. 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. K.N. Castorino: Research Support; Abbott, Dexcom, Inc. Speaker's Bureau; Dexcom, Inc. Research Support; Lilly Diabetes, Medtronic, MannKind Corporation, Insulet Corporation. Consultant; Medscape. B.E. Marks: Research Support; Tandem Diabetes Care, Inc., Dexcom, Inc., Medtronic, Digostics. Advisory Panel; International Society for Pediatric and Adolescent Diabetes, American Diabetes Association, T1D Exchange. Board Member; Juvenile Diabetes Research Foundation (JDRF). R. Lal: Consultant; Abbott, Adaptyx Biosciences, Biolinq, Capillary Biomedical, Inc., Deep Valley Labs, Gluroo, PhysioLogic Devices, Portal Insulin, Tidepool. Advisory Panel; Lilly Diabetes. C. Pihoker: None. 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. 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. B. Sunil: None. B.W. Bode: Research Support; Omnipod. Speaker's Bureau; Omnipod. Research Support; Medtronic. Advisory Panel; Medtronic. J.L. Sherr: Consultant; Medtronic. Advisory Panel; Medtronic, Insulet Corporation. Speaker's Bureau; Insulet Corporation. Advisory Panel; Vertex Pharmaceuticals Incorporated, MannKind Corporation, StartUp Health T1D Moonshot, Bigfoot Biomedical, Inc., Cecelia Health. Speaker's Bureau; Zealand Pharma A/S. L. Ekhlaspour: Advisory Panel; Medtronic. Consultant; Medtronic, Tandem Diabetes Care, Inc. Advisory Panel; Tandem Diabetes Care, Inc. Research Support; Medtronic, MannKind Corporation. Advisory Panel; Sequel. Other Relationship; National Institutes of Health. Research Support; Juvenile Diabetes Research Foundation (JDRF). Speaker's Bureau; Insulet Corporation. J.H. Reed: None. M. Abuzzahab: Research Support; Ascendis Pharma A/S. Consultant; Ascendis Pharma A/S. Research Support; Medtronic, MannKind Corporation, Rhythm Pharmaceuticals, Inc. Consultant; Rhythm Pharmaceuticals, Inc. Research Support; Novo Nordisk. M. Church: None. Z. Dai: Employee; Medtronic. H. Ma: None. J. Solomon: None. Y. Treminio: Employee; Medtronic. J. Shin: None. A.S. Rhinehart: Employee; Medtronic. Stock/Shareholder; Medtronic. J. McVean: Employee; Medtronic. R.A. Vigersky: Employee; Medtronic.