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Randomized Controlled Trial
. 2024 Jul;18(4):764-770.
doi: 10.1177/19322968241231307. Epub 2024 Feb 19.

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

Melissa H Lee  1   2 , Sara Vogrin  1 , Timothy W Jones  3   4   5 , David N O'Neal  1   2   6
Affiliations
Randomized Controlled Trial

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

Melissa H Lee et al. J Diabetes Sci Technol. 2024 Jul.

Abstract

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], P = .001). The mean increase in TIR was +14.8 (11.0, 18.5)%. GRI negatively correlated with TIR for combined arms (r = -.954; P = .001), and positively with TAR >250 mg/dL (r = .901; P = .001), TBR < 54 mg/dL (r = .416; P = .001), and glycemic variability (SD [r = .916] and CV [r = .732]; P = .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.

Keywords: closed-loop systems; continuous glucose monitoring; glycemia risk index; hyperglycemia; hypoglycemia; time in range; type 1 diabetes.

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Conflict of interest statement

Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MHL has received speaker honoraria from Medtronic. DNO. has served on advisory boards for Abbott Laboratories, Medtronic, Merck Sharp & Dohme, Novo Nordisk, Roche, and Sanofi; received research support from Medtronic, Novo Nordisk, Roche, Eli Lilly and Company, and Sanofi; and received travel support from Novo Nordisk and Merck Sharp & Dohme. SV and TWJ have nothing to disclose.

Figures

Figure 1.
Figure 1.
A glycemic risk index grid showing the hyperglycemia component vs the hypoglycemia component according to treatment group at (a) baseline and (b) study-end. Abbreviation: HCL, hybrid closed-loop.
Figure 2.
Figure 2.
Correlation between GRI and key CGM metrics, by treatment group, using Pearson’s correlation coefficient. (a) CGM 70-180mg/dL. (b) CGM 180-250mg/dL. (c) CGM >250mg/dL. (d) CGM 54-70mg/dL. (e) CGM <54mg/dL. (f) HbA1c (%). (g) Mean glucose (mg/dL). (h) SD glucose (mg/dL). (i) CV glucose (%). Solid red line represents HCL group; dashed black line represents control group. Abbreviations: CGM, continuous glucose monitoring; CV, coefficient of variation; GRI, glycemic risk index; HCL, hybrid closed-loop.
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