Introduction and Objective: Diabetes management and outcomes often differ by sex, influenced by biological and psychobehavioral factors. Our objective was to examine sex differences in glycemic outcomes during the safety and feasibility testing of the AIDANET automated insulin delivery system (AID)Methods: Participants with T1D enrolled in a randomized crossover trial of usual care (overwhelmingly AID with meal bolus, UC) vs the AIDANET system in FCL (without premeal boluses). FCL management consisted of a supervised phase followed by a week of home use. Glycemic metrics for FCL home use compared to UC were analyzed by sex subgroups considering males (M) and females of reproductive age not using contraception (FRA)Results: Of the 34 participants completing the trial, 12 were M and 10 FRA. For M, FCL showed significant improvements in TAR, TAR250 and mean glucose (UC: 185±29.1 mg/dL, FCL:169.2±17.3 mg/dL, p=0.046); and non-inferiority for TIR, TTR 70-140mg/dL (p=0.014) and TBR54. For FRA, FCL showed non-inferiority on mean glucose (UC: 184.3±42.9 mg/dL, FCL:161±14.6 mg/dL, p=0.031), TTR (p=0.030), TAR250 and TBR54; and increased TBR.Conclusion: AIDANET in FCL improved glycemia in males without compromising it in females, while eliminating the need for manual meal boluses. Glycemia could be improved for females with T1D by devising innovative FCL systems that account for the sex differences.
M. Moscoso-Vasquez: Other Relationship; Dexcom, Inc. Research Support; Tandem Diabetes Care, Inc, National Institute of Diabetes and Digestive and Kidney Diseases. J.Y. Hosseinipour: None. D. Flanagan: None. D. Fulkerson: None. S.A. Brown: Research Support; Dexcom, Inc., Insulet Corporation, Tandem Diabetes Care, Inc, Tolerion, Roche Diabetes Care. Other Relationship; MannKind Corporation. L. Ekhlaspour: Other Relationship; Medtronic. Advisory Panel; Abbott, Medtronic. Consultant; Jaeb Center for Health Research. Research Support; MannKind Corporation. Speaker’s Bureau; Insulet Corporation. Advisory Panel; Sequel Med Tech. Other Relationship; Tandem Diabetes Care, Inc. Research Support; Abbott. Other Relationship; Sanofi. G.P. Forlenza: Advisory Panel; Medtronic. Research Support; Medtronic, Dexcom, Inc. Consultant; Dexcom, Inc. Research Support; Insulet Corporation. Consultant; Insulet Corporation. Research Support; Tandem Diabetes Care, Inc. Advisory Panel; Tandem Diabetes Care, Inc. Research Support; Abbott. Advisory Panel; Sequel Med Tech. M.D. Breton: Speaker’s Bureau; Sinocare Inc, Tandem Diabetes Care, Inc. Consultant; Roche Diabetes Care, Boydsense. E. Cengiz: Advisory Panel; Novo Nordisk, Arecor Therapeutics, Eli Lilly and Company, Tandem Diabetes Care, Inc, Portal Insulin, MannKind Corporation.
Breakthrough T1D (2-SRA-2023-1275-M-B)
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