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Randomized Controlled Trial
. 2024 Sep;18(5):1132-1138.
doi: 10.1177/19322968231161320. Epub 2023 Mar 22.

Advanced Hybrid Closed Loop in Adult Population With Type 1 Diabetes: A Substudy From the ADAPT Randomized Controlled Trial in Users of Real-Time Continuous Glucose Monitoring

Tim van den Heuvel  1 , Ralf Kolassa  2 , Winfried Keuthage  3 , Jens Kroeger  4 , Roseline Ré  1 , Simona de Portu  1 , Linda Vorrink  1 , John Shin  5 , Javier Castañeda  1 , Robert Vigersky  5 , Ohad Cohen  1
Affiliations
Randomized Controlled Trial

Advanced Hybrid Closed Loop in Adult Population With Type 1 Diabetes: A Substudy From the ADAPT Randomized Controlled Trial in Users of Real-Time Continuous Glucose Monitoring

Tim van den Heuvel et al. J Diabetes Sci Technol. 2024 Sep.

Abstract

Background: This analysis reports the findings from a predefined exploratory cohort (cohort B) from the ADAPT (ADvanced Hybrid Closed Loop Study in Adult Population with Type 1 Diabetes) study. Adults with type 1 diabetes (T1D) with suboptimal glucose control were randomly allocated to an advanced hybrid closed-loop (AHCL) system or multiple daily injections of insulin (MDI) plus real-time continuous glucose monitoring (RT-CGM).

Methods: In this prospective, multicenter, exploratory, open-label, randomized controlled trial, 13 participants using MDI + RT-CGM and with HbA1c ≥8.0% were randomized to switch to AHCL (n = 8) or continue with MDI + RT-CGM (n = 5) for six months. Prespecified endpoints included the between-group difference in mean change from baseline in HbA1c, CGM-derived measures of glycemic control, and safety.

Results: The mean HbA1c level decreased by 1.70 percentage points in the AHCL group versus a 0.60 percentage point decrease in the MDI + RT-CGM group, with a model-based treatment effect of -1.08 percentage points (95% confidence interval [CI] = -2.17 to 0.00 percentage points; P = .0508) in favor of AHCL. The percentage of time spent with sensor glucose levels between 70 and 180 mg/dL in the study phase was 73.6% in the AHCL group and 46.4% in the MDI + RT-CGM group; model-based between-group difference of 28.8 percentage points (95% CI = 12.3 to 45.3 percentage points; P = .0035). No diabetic ketoacidosis or severe hypoglycemia occurred in either group.

Conclusions: In people with T1D with HbA1c ≥8.0%, the use of AHCL resulted in improved glycemic control relative to MDI + RT-CGM. The scale of improvement suggests that AHCL should be considered as an option for people not achieving good glycemic control on MDI + RT-CGM.

Keywords: HbA1c; automated insulin delivery; closed-loop system; diabetes; hyperglycemia; hypoglycemia; time in range.

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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: WK has received speaker fees from Medtronic and support for travel and attending ADAPT study meetings from Medtronic. JK has received payment and honoraria for lectures and presentations from Medtronic. RR, SdP, LV, JS, JC, TvdH, RV and OC are current employees and shareholders of Medtronic. RK declares no competing interests.

Figures

Figure 1.
Figure 1.
Participant flow diagram. Abbreviations: AHCL, advanced hybrid closed loop; MDI + RT-CGM, multiple daily injections of insulin + real-time continuous glucose monitoring.
Figure 2.
Figure 2.
Mean change in HbA1c. Error bars are 95% CIs. Figure based on available data. Abbreviations: AHCL, advanced hybrid closed loop; CI, confidence interval; HbA1c, glycated hemoglobin; MDI + RT-CGM, multiple daily injections of insulin + real-time continuous glucose monitoring.
See this image and copyright information in PMC

References

    1. de Portu S, Vorrink L, Re R, et al. Randomised controlled trial of advanced hybrid closed loop in an adult population with type 1 diabetes (ADAPT): study protocol and rationale. BMJ Open. 2022;12(2):e050635. - PMC - PubMed
    1. Choudhary P, Kolassa R, Keuthage W, et al. ; ADAPT study Group. Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study. Lancet Diabetes Endocrinol. 2022;10:720-731. - PubMed
    1. Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care. 2019;42(8):1593-1603. - PMC - PubMed
    1. Choudhary P, Campbell F, Joule N, Kar P; Diabetes UK. A Type 1 diabetes technology pathway: consensus statement for the use of technology in Type 1 diabetes. Diabet Med. 2019;36(5):531-538. - PubMed
    1. Grunberger G, Sherr J, Allende M, et al. American Association of Clinical endocrinology clinical practice guideline: the use of advanced technology in the management of persons with diabetes mellitus. Endocr Pract. 2021;27(6):505-537. - PubMed

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