Use of Continuous Glucose Monitoring Indicators to Guide Dose Titration of Weekly Basal Insulin Efsitora Alfa in Insulin-Naive and Basal Insulin-Experienced Adults with Type 2 Diabetes: A Retrospective Analyis.
Abstract
INTRODUCTION Basal insulin dose titration has historically relied on fasting self-monitoring blood glucose (SMBG) and hypoglycemic events. This retrospective analysis of the QWINT-2 and QWINT-3 Phase 3 trials aimed to evaluate the use of continuous glucose monitoring (CGM)-derived indicators for weekly insulin efsitora alfa (efsitora) titration in insulin-naive and basal insulin-experienced adults with type 2 diabetes (T2D) through dose-to-dose comparisons with self-monitoring fasting plasma glucose (FPG) and CGM-derived hypoglycemic events, and by assessing concordance between CGM fasting indicators and FPG independent of insulin dose adjustment.
Methods
CGM and self-monitoring FPG data from QWINT-2 (insulin-naive, N = 466) and QWINT-3 (basal insulin-experienced, N = 655) efsitora-treated participants were analyzed. CGM fasting indicators were compared with FPG through weekly dose-to-dose titration decisions following the SMBG-based Phase 3 trial dose titration algorithm, and by assessing concordance between CGM fasting indicator and FPG values. CGM hypoglycemia indicators were assessed weekly for agreement with CGM-derived hypoglycemic events below 70 mg/dL and 54 mg/dL following the SMBG-based Phase 3 trial hypoglycemia criteria. User burden was considered, with low burden meaning a CGM indicator was readily available in an ambulatory glucose profile (AGP) report.
Results
CGM hypoglycemia indicators demonstrated 91.5%-98.3% agreement with CGM-derived hypoglycemic events in QWINT-2 and QWINT-3. CGM fasting indicators "Lowest median of AGP," and "Typical fasting 25% from AGP" demonstrated clinical equivalency with FPG, with dose differences within 20 weekly units for 90.7%-93.4% of dose decisions for both studies.
Conclusion
In insulin-naive and basal insulin-experienced populations treated with weekly efsitora, CGM indicators of hypoglycemia and fasting glucose yielded clinically equivalent dose titration decisions as CGM-derived hypoglycemic events and self-monitoring FPG, respectively. These findings support translation of established titration practices to a CGM-based workflow in insulin-naive and basal insulin-experienced adults with T2D, consistent with recommendations for CGM use in adults with diabetes on insulin therapy.