Diabetes technology

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

J Diabetes Sci TechnolPublished Post hoc analysis of a randomised controlled trial

Primary result · GRIResult — go to the resultMean difference −22.8 CI −27.2 to −18.3

Authors' conclusion

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.

Study context

Population
Adults with T1D
Participants
61 vs 59
Comparison
Hybrid closed-loop (HCL) vs manual insulin delivery
  • HCLn = 61
  • Controln = 59reference
Primary endpoint
Glycemia risk index (GRI), HCL vs control
Follow-up
26 weeks

Primary result

GRI

Mean difference

−22.8

CI −27.2 to −18.3

P = 0.001

By group

HCL

33.5

mean · SD 11.7

Control

56.1

mean · SD 14.4

HCLvs Control
mean difference −22.8 (CI −27.2 to −18.3); P = 0.001

As reported in the abstract

Further findings

Time in range (TIR)

Mean increase in TIR
+14.8 (11.0, 18.5)%

Correlation of glycemia risk index (GRI) with continuous glucose monitoring (CGM) metrics (combined arms)

GRI vs TIR (P = .001)
r = −.954
GRI vs time above range (TAR) >250 mg/dL (P = .001)
r = .901
GRI vs time below range (TBR) < 54 mg/dL (P = .001)
r = .416
GRI vs glycemic variability SD (P = .001)
r = .916
GRI vs CV (P = .001)
r = .732

Original publication

Hybrid Closed-Loop Versus Manual Insulin Delivery in Adults With Type 1 Diabetes: A Post Hoc Analysis Using the Glycemia Risk Index. J Diabetes Sci Technol. Published 19 February 2024. doi:10.1177/19322968241231307

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