1342-OR: CGM Data Provides Weekly Insulin Efsitora Dose Guidance Equivalent to the Current Standard of FBG and Hypoglycemia Events for T2D Insulin Naïve Adults: A Retrospective Analysis

Introduction and Objective: Basal insulin dose titration is traditionally guided by self-monitored FBG and documented hypoglycemic events. This retrospective analysis evaluated CGM-derived indicators for use in dose titration of weekly basal insulin in insulin-naïve adults with T2D. Methods: CGM indicators of FBG were calculated from 3730 weekly insulin dose decisions, while hypoglycemic events were assessed using CGM data from 6075 weeks in a phase 3 trial of once weekly insulin efsitora alfa (efsitora) in insulin-naïve adults with T2D (N=466). Following similar dosing titration guidance as in the clinical trial, clinical equivalency of paired CGM-fasting indicators vs self-monitored FBG was assessed by dose-to-dose comparisons. TBR thresholds were assessed for concordance with Level 1/2 (70 mg/dL), Level 2 (54 mg/dL), and nocturnal CGM-hypoglycemic events. User burden was considered for data availability from CGM reports. Results: Use of CGM-fasting indicators showed dose-to-dose clinical equivalency to self-monitored FBG (90% of decisions, with mean dose differences within 20 units per week). ‘Typical fasting 25% percentile’ and ‘lowest median ambulatory glucose profile’ were identified as top candidates with 91-93% dose-to-dose clinical equivalency and lowest mean difference (-8.5 - -2.4 mg/dL) as well as low user burden. Determining whether participants experienced ≥2% TBR-70 mg/dL resulted in 94.8% agreement with CGM hypoglycemic events titration recommendations. A 0% TBR-54 mg/dL threshold and ≥1% nocturnal TBR-70 mg/dL threshold resulted in 92.5% and 98.2% agreement with titration recommendations based on CGM hypoglycemic events. Conclusion: Using CGM indicators of FBG resulted in equivalent dose-to-dose decisions as self-monitored FBG. Results demonstrated strong agreement between TBR thresholds and CGM-derived hypoglycemic events. These findings support potential utility of CGM in efsitora titration. Disclosure R.M. Bergenstal: Other - Advisory Panel, Consultant, Clinical Research Support; Current; Abbott Diabetes. Other - Consultant, Clinical Research Support; Current; Dexcom, Inc. Research Support; Current; Amgen Inc. Advisory Panel; Current; CeQur SA. Other - Advisory Panel, Consultant, Clinical Research Support; Current; Eli Lilly and Company. Research Support; Current; Insulet Corporation. Research Support; Ended; Luna. Research Support; Current; Medtronic. Other - Advisory Panel, Consultant, Clinical Research Support; Current; Novo Nordisk. Research Support; Current; Tandem Diabetes Care, Inc. Consultant; Current; Sanofi. Advisory Panel; Current; Vertex Pharmaceuticals Incorporated. Research Support; Current; Zealand Pharma A/S, Sequel, Embecta. D. Ahn: Speaker's Bureau; Current; Abbott, Ascensia Diabetes Care, MannKind Corporation, Insulet Corporation, Lilly, Novo Nordisk, Xeris Pharmaceuticals, Inc., Sequel Medtech, Dexcom, Inc. Advisory Panel; Ended; Lilly, MannKind Corporation. D.L. Duke: Employee; Current; Eli Lilly and Company. M. Case: Employee; Current; Eli Lilly and Company. Stock/Shareholder; Current; Eli Lilly and Company. L.L. Ilag: Employee; Current; Eli Lilly and Company. Stock/Shareholder; Current; Eli Lilly and Company. M.B. Davidson: Employee; Current; Eli Lilly and Company. Stock/Shareholder; Current; Eli Lilly and Company. J. Johnson: Stock/Shareholder; Current; Eli Lilly and Company. T. Martens: Other - Research support, consulting; Current; Dexcom, Inc. Other - Research support, advisory panel; Current; Abbott Diabetes. Other - Research support, consulting; Current; Lilly. Other - Research support, advisory panel; Current; Sanofi. Research Support; Current; Tandem Diabetes Care, Inc., MannKind Corporation, Zealand Pharma A/S. Research Support; Ended; Omnipod. Research Support; Current; Novo Nordisk, Medtronic, Sequel. G. Aleppo: Advisory Panel; Current; Medscape, Tandem Diabetes Care, Inc. Consultant; Current; Eli Lilly and Company, Dexcom, Inc., Insulet Corporation. Research Support; Current; AbbVie Inc., Bayer, Fractyl, Insulet Corporation, MannKind Corporation, Tandem Diabetes Care, Inc., Medtronic. E.M. Miller: Advisory Panel; Current; Abbott. Speaker's Bureau; Current; Bayer AG, Corcept Therapeutics, Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi. E. Dassau: Employee; Current; Eli Lilly and Company. Stock/Shareholder; Current; Eli Lilly and Company. Funding Eli Lilly and Company