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12 个月迷你美敦力 780G 高级闭环系统治疗 1 型糖尿病患者的真实世界疗效:一项法国观察性、回顾性、多中心研究。

12-Month Real-Life Efficacy of the MiniMed 780G Advanced Closed-Loop System in Patients Living with Type 1 Diabetes: A French Observational, Retrospective, Multicentric Study.

机构信息

Grenoble Alpes Univeristy, Grenoble Alpes University Hospital, Endocrinology-Diabetology-Nutrition Department, University, Saint-Martind'Heres, France.

Endocrinology-Diabetology Department, Brest University Hospital, Brest, France.

出版信息

Diabetes Technol Ther. 2024 Jun;26(6):426-432. doi: 10.1089/dia.2023.0414. Epub 2024 Feb 7.

Abstract

To evaluate the evolution of glycemic outcomes in patients living with type 1 diabetes (T1D) after 1 year of use of the MiniMed 780G advanced hybrid closed-loop (AHCL) system. We conducted an observational, retrospective, multicentric study in 20 centers in France. The primary objective was to evaluate the improvement in glycemic control after 1-year use of AHCL. The primary endpoint was the variation of time in range (TIR) between pre-AHCL and after 1-year use of AHCL. Secondary objectives were to analyze the glycemic outcomes after 3, 6, and 12 months of AHCL use, the safety, and the long-term observance of AHCL. Two hundred twenty patients were included, and 200 were analyzed for the primary endpoint. 92.7% of patients continued to use AHCL. After 1 year of use of AHCL, TIR was 72.5% ± 10.6% (+9.1%; 95% confidence interval [CI] [7.6-10.5] compared to pre-AHCL initiation,  < 0.001), HbA1c 7.1% ± 0.7% (-0.5%; 95% CI [-0.6 to -0.4];  < 0.001), time below range 2.0% [1.0; 3.0] (0.0% [-2.0; 0.0],  < 0.001), and time above range 24.8% ± 10.9% (-7.3%; 95% CI [-8.8 to -5.7];  < 0.001). More patients achieved the glycemic treatment goals of HbA1c <7.0% (45.1% vs. 18.1%,  < 0.001) and TIR >70% (59.0% vs. 29.5%  < 0.001) when compared with pre-AHCL. Five patients experienced severe hypoglycemia events and two patients experienced ketoacidosis. After 1 year of use of AHCL, people living with T1D safely improved their glucose control and a higher proportion of them achieved optimal glycemic control.

摘要

评估使用 MiniMed 780G 高级混合闭环 (AHCL) 系统 1 年后 1 型糖尿病 (T1D) 患者的血糖控制变化情况。我们在法国的 20 个中心进行了一项观察性、回顾性、多中心研究。主要目的是评估 AHCL 使用 1 年后血糖控制的改善情况。主要终点是 AHCL 使用前和使用 1 年后时间在目标范围内 (TIR) 的变化。次要目标是分析 AHCL 使用 3、6 和 12 个月后的血糖结果、安全性和 AHCL 的长期观察。共纳入 220 例患者,其中 200 例患者对主要终点进行了分析。92.7%的患者继续使用 AHCL。在使用 AHCL 1 年后,TIR 为 72.5%±10.6%(+9.1%;95%置信区间 [CI] [7.6-10.5] 与 AHCL 启动前相比,  < 0.001),HbA1c 为 7.1%±0.7%(-0.5%;95%置信区间 [CI] [-0.6 至 -0.4];  < 0.001),血糖低于目标范围 2.0%[1.0;3.0](0.0%[-2.0;0.0],  < 0.001),血糖高于目标范围 24.8%±10.9%(-7.3%;95%置信区间 [-8.8 至 -5.7];  < 0.001)。与 AHCL 启动前相比,更多的患者达到了 HbA1c<7.0%(45.1% 对 18.1%,  < 0.001)和 TIR>70%(59.0% 对 29.5%,  < 0.001)的血糖治疗目标。有 5 例患者发生严重低血糖事件,2 例患者发生酮症酸中毒。使用 AHCL 1 年后,1 型糖尿病患者的血糖控制得到了安全改善,并且更多的患者达到了最佳血糖控制水平。

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