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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 19.01.2021, 12:47 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.

Funding

This pre-launch project was supported by CERITD and Diabeloop SA. The findings and conclusions in this study are those of the authors and do not necessarily represent the views of the sponsors.

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