@article{8eb2e6513d654a6199d1e230cce8c551,
title = "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",
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",
author = "{van den Heuvel}, Tim and Ralf Kolassa and Winfried Keuthage and Jens Kroeger and Roseline R{\'e} and {de Portu}, Simona and Linda Vorrink and John Shin and Javier Casta{\~n}eda and Robert Vigersky and Ohad Cohen",
note = "Publisher Copyright: {\textcopyright} 2023 Diabetes Technology Society.",
year = "2024",
month = sep,
doi = "10.1177/19322968231161320",
language = "אנגלית",
volume = "18",
pages = "1132--1138",
journal = "Journal of diabetes science and technology",
issn = "1932-2968",
publisher = "SAGE Publications Inc.",
number = "5",
}