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

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posted on 2021-01-19, 12:47 authored by Coralie Amadou, Sylvia Franc, Pierre-Yves Benhamou, Sandrine Lablanche, Erik Huneker, Guillaume Charpentier, Alfred Penfornis, on behalf of the Diabeloop Consortium

OBJECTIVE To analyze safety and efficacy of the DBLG1 hybrid closed-loop artificial pancreas system in patients with Type 1 Diabetes in real life conditions. METHODS Following a one-week run-in period with usual pump, 25 patients were provided with the commercial DBLG1 system. We present the results of Time-in-Range and HbA1c over a 6-month period. RESULTS The mean (SD;range) age of patients was 43 years (13.8; 25-72). At baseline, mean HbA1c and TIR 70-180mg/dL were respectively 7.9% (0.93; 5.6- 8.5) [63mmol/mol (10; 38-69)] and 53% (16.4;21-85). One patient stopped using the system after 2 months. At 6-month, mean HbA1c decreased to 7.1% [54mmol/mol] (p<0.001) and TIR 70-180mg/dL increased to 69.7% (p<0.0001). TIR<70mg/dL decreased from 2.4 to 1.3% (p=0.03). TIR<54mg/dL decreased from 0.32 to 0.24% (p=0.42). No serious adverse event was reported during the study. CONCLUSION The DBLG1 System confirms its ability to significantly improve glycemic control in real life conditions, without serious adverse events.