Safety and Functionality of a Novel Clinical Decision-Support Algorithm with Insulin Efsitora Alfa in Adults with Type 2 Diabetes: Early Feasibility Study.

Introduction: For people with type 2 diabetes (T2D), optimal glycemic control is critical. Digital health interventions are a practical approach to improve T2D self-management. This study explored the safety and functionality of a novel clinical decision-support (CDS) application for individualized dosing of insulin efsitora (efsitora), a once-weekly basal insulin receptor agonist. Participants and Methods: This was a 16-week, multicenter, open-label early feasibility study in adults with T2D with or without basal insulin. Investigators requested an efsitora dose from the CDS algorithm and either overrode or accepted the recommendation. Dose recommendation overrides (primary endpoint), finger-stick glucose, blinded continuous glucose monitoring metrics, and hypoglycemic events were evaluated. Results: Two sequential cohorts consisted of 68 participants; each cohort included insulin-naïve and basal-switch participants. In both cohorts, mean glycated hemoglobin (HbA1c) for basal-switch participants ranged from 7.9% to 8.5%. Mean HbA1c for insulin-naïve participants ranged from 8.1% to 8.3%. CDS dosing recommendation overrides occurred for 0.7% of injections for basal-switch participants and for 1.0% of injections for insulin-naïve participants in Cohort 1. For Cohort 2, overrides occurred for 1.3% of injections for insulin-naïve participants, with no overrides for basal-switch participants. HbA1c was significantly reduced (P < 0.05) from baseline to Week 16 in both subgroups for both cohorts. The proportion of participants with fasting blood glucose within the targets increased from baseline to Week 16 in both subgroups for both cohorts. No level 3 hypoglycemia was observed. Conclusions: The novel CDS algorithm showed promising clinical performance and favorable investigator confidence as determined by a low rate of dose overrides.