Hybrid Closed-Loop Versus Manual Insulin Delivery in Adults With Type 1 Diabetes: A Post Hoc Analysis Using the Glycemia Risk Index.

Background: Glycemia risk index (GRI) is a novel composite metric assessing overall glycemic risk, accounting for both hypoglycemia and hyperglycemia and weighted toward extremes. Data assessing GRI as an outcome measure in closed-loop studies and its relation with conventional key continuous glucose monitoring (CGM) metrics are limited.

Methods: A post hoc analysis was performed to evaluate the sensitivity of GRI in assessing glycemic quality in adults with type 1 diabetes randomized to 26 weeks hybrid closed-loop (HCL) or manual insulin delivery (control). The primary outcome was GRI comparing HCL with control. Comparisons were made with changes in other CGM metrics including time in range (TIR), time above range (TAR), time below range (TBR), and glycemic variability (standard deviation [SD] and coefficient of variation [CV]).

Results: GRI with HCL (N = 61) compared with control (N = 59) was significantly lower (mean [SD] 33.5 [11.7] vs 56.1 [14.4], respectively; mean difference -22.8 [-27.2, -18.3], = .001). The mean increase in TIR was +14.8 (11.0, 18.5)%. GRI negatively correlated with TIR for combined arms ( = -.954; = .001), and positively with TAR >250 mg/dL ( = .901; = .001), TBR < 54 mg/dL ( = .416; = .001), and glycemic variability (SD [ = .916] and CV [ = .732]; = .001 for both).

Conclusions: Twenty-six weeks of HCL improved GRI, in addition to other CGM metrics, compared with standard insulin therapy. The improvement in GRI was proportionally greater than the change in TIR, and GRI correlated with all CGM metrics. We suggest that GRI may be an appropriate primary outcome for closed-loop trials.