First Generation of a Modular Interoperable Closed-Loop System for Automated Insulin Delivery in Patients With Type 1 Diabetes: Lessons From Trials and Real-Life Data.

ABSTRACT

BACKGROUND: DBLG1 (Diabeloop Generation 1) stands as one of the five commercially available closed-loop solution worldwide for patients with type 1 diabetes as of 2023. Our aim was to provide an overview of all data obtained with this system regarding outcomes and populations, with an emphasis on interoperability. METHODS: This report includes all available sources of data (three randomized control trials and five surveys on real-life data). Collection ran from March 3, 2017 to April 30, 2022. RESULTS: We gathered data from 6859 adult patients treated with closed-loop from three to 12 months. Overall, all sources of data showed that time in range (TIR) 70 to 180 mg/dL, starting from 47.4% to 56.6%, improved from 12.2 to 17.3 percentage points. Time in hypoglycemia was reduced by 48% in average (range 26%-70%) and reached a level of 1.3% in the largest and most recent cohort. In patients with excessive time in hypoglycemia at baseline (≥5%), closed-loop allowed a reduction in time below range (TBR) by 59%. The comparison of days with declared physical activity versus days without physical activity did not show differences in TBR. The improvement in TIR observed with three different pump systems (Vicentra Kaleido, n = 117; Sooil Dana-I, n = 84; and Roche Insight, n = 6684) ranged from 15.4 to 17.3 percentage points. DISCUSSION: These data obtained in different European countries were consistent throughout all reports, showing that this closed-loop system is efficient (high improvement in TIR), safe (remarkably low level of TBR), and interoperable (three pump settings so far).