1059-P: Glycemic Outcomes from the MiniMed™ 670G System Pivotal Trials in Patients 2-75 Years of Age

Abstract

Background: The MiniMed™ 670G system is FDA-approved and CE-marked for patients with T1D aged ≥7 years. Glycemic outcomes of patients aged 2-75 years with T1D using the system at home for 3 months were evaluated and compared. Methods: Data from 151 children (n=46, 2-6 years and n=105, 7-13 years) enrolled at 9 sites; and 124 adolescents and adults (n=30, 14-21 years and n=94, 22-75 years) enrolled at 10 sites, during 2-week Manual Mode use (run-in phase) followed by 3-month Auto Mode use (study phase) were analyzed. Glycemic outcomes (HbA1c, time spent at sensor glucose [SG] ranges, SG, and SG variability, etc.) were compared across age groups. Results: Data from run-in and study phases are shown (Table). Across age groups there was a 0.4% to 0.5% decrease in HbA1c and a 5.5% to 8.8% increase in time in range. During the study phases of the pediatric (2-13 years) and older cohort (14-75 years) trials, there were no episodes of severe hypoglycemia or DKA, and no serious device-related adverse events. Conclusions: These findings indicate that 3-month MiniMed™ 670G Auto Mode use in patients as young as two years of age with T1D, similar to older cohorts using the system, can safely improve glycemic outcomes compared to 2-week open-loop Manual Mode. Disclosure T.S. Bailey: Advisory Panel; Self; Abbott. Consultant; Self; Capillary Biomedical, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Sanofi. Research Support; Self; Abbott, Ascensia Diabetes Care, Becton, Dickinson and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Calibra Medical, Capillary Biomedical, Inc., Companion Medical, Dance Biopharm Holdings Inc., Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, GlySens Incorporated, Kowa Pharmaceutical Europe Co. Ltd., Lexicon Pharmaceuticals, Inc., Medtronic, Novo Nordisk Inc., POPS! Diabetes Care, POPS! Diabetes Care, Sanofi, Senseonics, vTv Therapeutics, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. Speaker's Bureau; Self; Abbott, MannKind Corporation, Medtronic, Novo Nordisk Inc., Sanofi US, Senseonics. B.W. Bode: Consultant; Self; ADOCIA, Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc. Research Support; Self; Becton, Dickinson and Company, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Eyenuk Inc., Insulet Corporation, National Institutes of Health, Novo Nordisk Inc., Sanofi Research & Development, Senseonics, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US, Senseonics. Stock/Shareholder; Self; AgaMatrix, Glytec, LLC. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc. Consultant; Self; Medtronic MiniMed, Inc., Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. O. Pinhas-Hamiel: None. K.K. Kaiserman: Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Medtronic MiniMed, Inc. Speaker's Bureau; Self; Medtronic MiniMed, Inc. D.R. Liljenquist: None. D.I. Shulman: None. M.A. Wood: None. X. Chen: None. J. Shin: Employee; Self; Medtronic. T.L. Cordero: Employee; Self; Medtronic. S.W. Lee: Employee; Self; Medtronic. F.R. Kaufman: Employee; Self; Medtronic.