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Randomized Controlled Trial
. 2024 Oct 1;47(10):1778-1786.
doi: 10.2337/dc24-0623.

Closed-Loop Insulin Therapy for People With Type 2 Diabetes Treated With an Insulin Pump: A 12-Week Multicenter, Open-Label Randomized, Controlled, Crossover Trial

Anne-Laure Borel  1 , Sandrine Lablanche  2 , Christine Waterlot  3 , Eloïse Joffray  4 , Céline Barra  4 , Nathalie Arnol  4 , Hafid Amougay  5 , Pierre-Yves Benhamou  2
Affiliations
Randomized Controlled Trial

Closed-Loop Insulin Therapy for People With Type 2 Diabetes Treated With an Insulin Pump: A 12-Week Multicenter, Open-Label Randomized, Controlled, Crossover Trial

Anne-Laure Borel et al. Diabetes Care. .

Abstract

Objective: Continuous glucose monitoring (CGM) combined with continuous subcutaneous insulin infusion (CSII) achieves better glycemic control than multi-injection therapy in people with type 2 diabetes. The effectiveness of closed-loop therapy needs to be further evaluated in this population.

Research design and methods: The study objective was to measure the impact of a hybrid closed-loop device (DBLG1) compared with CSII + CGM on glycemic control in people with type 2 diabetes previously treated with CSII. The randomized, controlled, crossover, two-period, open-label, and multicenter study was conducted from August 2022 to July 2023 in 17 individuals (9 to receive 6 weeks of CSII + CGM first and 8 to receive 6 weeks of closed-loop therapy first). The primary end point was the percentage time in range (TIR: 70-180 mg/dL). Secondary outcomes were other CGM-glucose metrics, physical activity, and sleep objectively measured using 1-week actimetry.

Results: Data were analyzed using a modified intention-to-treat approach. Mean age was 63 (SD 9) years and 35% were women. Mean HbA1c at inclusion was 7.9% (SD 0.9). TIR increased to 76.0% (interquartile range 69.0-84.0) during the closed-loop condition vs. 61.0% (interquartile range 55.0-70.0) during the CSII + CGM condition; mean difference was 15.0 percentage points (interquartile range 8.0-22.0; P < 0.001). Analyses of secondary end points showed a decrease in time above range, in glucose management indicator, in glucose variability, and an increase in daily insulin dose. Actimetric sleep analysis showed an improvement in sleep fragmentation during closed-loop treatment.

Conclusions: Closed-loop therapy improved glycemic control more than did CSII + CGM in people with type 2 diabetes.

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Conflict of interest statement

Duality of Interest. A.-L.B. is married to Jean-Christian Borel, Scientific Director of Contract Research Organization ICADOM (France). C.B., E.J., and N.A. are employees of the Contract Research Organization ICADOM (France). P.-Y.B. has received personal fees as Chief Medical Officer from DIABELOOP SA. A.-L.B. (academic) and P.-Y.B. (academic involved as expert in the scientific board of DIABELOOP, Inc., which sponsored the study) directly accessed and verified the underlying data reported in the manuscript. No other potential conflicts of interest relevant to this article were reported.

Figures

None
Graphical abstract
Figure 1
Figure 1
Time in range during the closed-loop and the CSII + CGM periods.
Figure 2
Figure 2
Glucose control during the closed-loop and the CSII + CGM periods. The shaded areas show the 95% CI.
See this image and copyright information in PMC

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