Continuous Glucose Monitoring Metrics and Continuous Glucose Monitoring-Based Hypoglycemia, Including Duration, in Individuals with Type 1 Diabetes Switching to Once-Weekly Insulin Icodec: A Post Hoc Evaluation of ONWARDS 6.

Abstract

Background: Post hoc evaluation of ONWARDS 6 assessed continuous glucose monitoring (CGM) metrics and CGM-based hypoglycemia with once-weekly insulin icodec (icodec) and once-daily insulin degludec (degludec) in adults with type 1 diabetes. Methods: Open CGM data were collected throughout ONWARDS 6. During weeks 0-4, 22-26, and 48-52, time in range (TIR; 3.9-10.0 mmol/L), time above range (TAR; >10.0 mmol/L), and time below range (TBR; <3.9 and <3.0 mmol/L) were assessed by treatment day after icodec injection or degludec titration. Rates of CGM-based clinically significant hypoglycemic episodes (<3.0 mmol/L for ≥15 consecutive min) and durations of CGM-based hypoglycemic episodes (<3.9 mmol/L) and CGM-based periods <3.0 mmol/L were reported (baseline to weeks 26 and 57). Results: Although rates of overall CGM-based clinically significant hypoglycemia were statistically significantly higher with icodec than degludec from baseline to week 26 and week 57, estimated rate ratios (icodec/degludec) for CGM-based clinically significant hypoglycemic episodes were lower than those estimated from self-measured blood glucose (SMBG) data from baseline to week 26 (1.38 vs. 1.88) and to week 57 (1.28 vs. 1.79). Observed percentage of TIR was highest on days 2-4 after icodec injection with a concomitant reduction in TAR and an increase in TBR. Median duration of CGM-based hypoglycemic episodes was comparable between treatment arms from baseline to week 26 (icodec: 35 min; degludec: 30 min) and to week 57 (35 min for both treatments). Median duration of CGM-based periods <3.0 mmol/L was the same for both treatments at week 26 and week 57 (25 min). Conclusion: In adults with type 1 diabetes, estimated rate ratios for CGM-based clinically significant hypoglycemia were lower than those estimated from SMBG data, although still favoring degludec with estimated rate ratios of 1.28-1.38. CGM metrics varied by treatment day after icodec injection, but median duration of CGM-based hypoglycemia was comparable between treatment arms.