One-year real-world performance of the DBLG1 closed-loop system: Data from 3706 adult users with type 1 diabetes in Germany

Abstract

Aim: The Diabeloop Generation 1 (DBLG1) system is an interoperable hybrid closed-loop solution that was commercialized in Germany in March 2021. We report the longitudinal glycaemic outcomes among the first 3706 users in a real-world setting.

Methods: We performed a retrospective data collection of all consenting adult patients with type 1 diabetes who were equipped in Germany with the DBLG1 system before 30 April 2022, and with a minimum 14 days of closed-loop usage.

Results: In total, 3706 users (41% women, age 45.1 ± 14.5 years) met the inclusion criteria, reaching a mean follow-up of 131.0 ± 85.1 days, an overall 485 600 days of continuous glucose monitoring data, and a median time spent in closed-loop of 95.0% (IQR 89.1-97.4). The median percentage time in range (70-180 mg/dl) was 72.1% (IQR 65.0-78.9); the time below 70 mg/dl was 0.9% (0.5-1.7), the time below 54 mg/dl was 0.1% (0.1-0.3), and the median Glucose Management Index was 7.0% (6.8-7.3). Exploratory analysis of a subset of 2460 patients in whom baseline glycated haemoglobin (HbA1c) was available [7.4% (IQR 6.9-8.0)] showed that the achieved mean time in range was influenced by baseline HbA1c, ranging from 65.8 ± 9.9% (A1c ≥8.5%) to 81.3 ± 6.8% (A1c <6.5%).

Conclusion: This large real-world analysis confirms the relevance of the DBLG1 automated insulin delivery solution for the achievement of standards of care in adult patients with type 1 diabetes.

Keywords: artificial pancreas; automated insulin delivery; closed-loop; hyperglycaemia; hypoglycaemia; time in range; type 1 diabetes.