Diabeloop DBLG1 Closed-Loop System Enables Patients With Type 1 Diabetes to Significantly Improve Their Glycemic Control in Real-Life Situations Without Serious Adverse Events: 6-Month Follow-up.

OBJECTIVE: To analyze safety and efficacy of the Diabeloop Generation 1 (DBLG1) hybrid closed-loop artificial pancreas system in patients with type 1 diabetes in real-world conditions.

RESEARCH DESIGN AND METHODS: After a 1-week run-in period with their usual pump, 25 patients were provided the commercial DBLG1 system. The results are presented on time in range (TIR) and HbA1c over 6 months.

RESULTS: The mean (SD; range) age of patients was 43 (13.8; 25-72) years. At baseline, the mean HbA1c and TIR 70-180 mg/dL were, respectively, 7.9% (0.93; 5.6-8.5%) [63 mmol/mol (10; 38-69 mmol/mol)] and 53% (16.4; 21-85%). One patient stopped using the system after 2 months. At 6 months, the mean HbA1c decreased to 7.1% [54 mmol/mol] ( P < 0.001) and TIR 70-180 mg/dL increased to 69.7% ( P < 0.0001). TIR <70 mg/dL decreased from 2.4 to 1.3% ( P = 0.03), and TIR <54 mg/dL decreased from 0.32 to 0.24% ( P = 0.42). No serious adverse event was reported during the study.

CONCLUSIONS: The ability of the DBLG1 system to significantly improve glycemic control in real-world conditions, without serious adverse events, was confirmed in this follow-up study.