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Original Research
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
Coralie Amadou, Sylvia Franc, Pierre-Yves Benhamou, Sandrine Lablanche, Erik Huneker, Guillaume Charpentier, Alfred Penfornis, on behalf of the Diabeloop Consortium
Diabetes Care 2021 Jan; dc201809. https://doi.org/10.2337/dc20-1809
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Abstract

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.

  • Received July 20, 2020.
  • Accepted December 5, 2020.
  • © 2020 by the American Diabetes Association
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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
Coralie Amadou, Sylvia Franc, Pierre-Yves Benhamou, Sandrine Lablanche, Erik Huneker, Guillaume Charpentier, Alfred Penfornis, on behalf of the Diabeloop Consortium
Diabetes Care Jan 2021, dc201809; DOI: 10.2337/dc20-1809

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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
Coralie Amadou, Sylvia Franc, Pierre-Yves Benhamou, Sandrine Lablanche, Erik Huneker, Guillaume Charpentier, Alfred Penfornis, on behalf of the Diabeloop Consortium
Diabetes Care Jan 2021, dc201809; DOI: 10.2337/dc20-1809
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© 2021 by the American Diabetes Association. Diabetes Care Print ISSN: 0149-5992, Online ISSN: 1935-5548.