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

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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DOI:
10.2337/dc20-1809
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发表时间:
2021-03-01
期刊:
影响因子:
16.2
通讯作者:
Penfornis, Alfred
Penfornis, Alfred
中科院分区:
医学1区
文献类型:
--
作者:
Amadou, Coralie;Franc, Sylvia;Penfornis, Alfred

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目的分析diabelloop Generation 1 (DBLG1)混合型闭环人工胰腺系统在1型糖尿病患者中的安全性和有效性。研究设计与方法25例患者在使用常规泵1周后,接受商用DBLG1系统。结果在6个月的时间范围(TIR)和HbA(1c)上显示。结果患者平均(SD; range)年龄为43岁(13.8;25-72)岁。基线时,平均HbA(1c)和TIR 70-180 mg/dL分别为7.9% (0.93;5.6-8.5%)[63 mmol/mol (10; 38-69 mmol/mol)]和53%(16.4;21-85%)。一名患者在2个月后停止使用该系统。6个月时,平均HbA(1c)降至7.1% [54 mmol/mol] (P < 0.001), TIR 70-180 mg/dL升高至69.7% (P < 0.0001)。行动
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 HbA(1c) over 6 months. RESULTS The mean (SD; range) age of patients was 43 (13.8; 25-72) years. At baseline, the mean HbA(1c) 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 HbA(1c) decreased to 7.1% [54 mmol/mol] (P < 0.001) and TIR 70-180 mg/dL increased to 69.7% (P < 0.0001). TIR