ADVANCED HYBRID CLOSED LOOP STUDY IN AN ADULT POPULATION WITH TYPE 1 DIABETES (ADAPT): A RANDOMIZED CONTROLLED STUDY

Abstract

Background The aim was to assess the efficacy of an advanced hybrid closed loop (AHCL) system compared with multiple daily injections (MDI) and intermittently-scanned continuous glucose monitoring (isCGM) therapy in adults with type 1 diabetes (T1D) with suboptimal glucose control. Methods This prospective, multi-center, open-label, randomized controlled trial was conducted across fourteen centers in three European countries and enrolled patients aged ≥18 years, with T1D duration ≥2 years, HbA1c ≥8·0% using MDI+isCGM for ≥3 months. After a 2-week baseline run-in, eligible participants were randomized to AHCL therapy or continuation of MDI+isCGM for 6 months. The primary endpoint was the between-group difference in mean change from baseline to 6 months in HbA1c in the intention-to-treat population. (Registered with ClinicalTrials.gov; number NCT04235504). Findings Between 13 July 2020 and 12 March 2021, N=105 people were screened and n=82 randomly allocated to treatment (n=41 in each arm). At 6 months, mean (±SD) HbA1c had decreased by 1·54±0·73% in the AHCL group and 0·20±0·80% in the MDI+isCGM group, resulting in a model-based treatment effect of −1·42% (95% confidence interval [CI] −1·74 to −1·10%; p<0.0001) in favor of AHCL. The percentage of time spent with sensor glucose levels between 70–180 mg/dL was 70·6±9·70% in the AHCL group and 43·6±15·37% in the MDI+isCGM group, resulting in a model-based between group difference of 27·6% (95% CI 21·6 to 33·6, p<0·0001) in favor of AHCL. No diabetic ketoacidosis and no severe hypoglycemia occurred in either group; two severe hypoglycemic events occurred in the run-in phase. Interpretation In people with T1D using MDI+isCGM and with HbA1c ≥8·0% the use of AHCL confers benefits in terms of glycemic control and treatment satisfaction beyond those that can be achieved with MDI+isCGM therapy. These data support wider access to AHCL in people with T1D not at target glucose levels.