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第一代模块化互操作闭环系统用于1型糖尿病患者的自动胰岛素输送:从试验和现实生活数据中吸取教训
Pierre-Yves Benhamou1,2, Alice Adenis3, Sandrine Lablanche1
1Department of Endocrinology, Grenoble University Hospital, Grenoble Alpes University, INSERM U1055, Laboratory of Fundamental and Applied Bioenergetics, Grenoble, France.
迪亚贝洛普第1代闭环系统显著改善了范围内的时间,并减少了1型糖尿病患者的低血糖症. 这种高效,安全和可互操作的系统在各种种群和类型中显示出一致的结果.
科学领域:
- 内分泌学 在内分泌学.
- 医疗器械 医疗器械
- 糖尿病 技术 技术
背景情况:
- Diabeloop第1代 (DBLG1) 是一款用于1型糖尿病管理的领先商业闭环系统.
- 它是2023年全球五个这样的系统之一.
研究的目的:
- 提供关于DBLG1系统结果和患者群体的数据的全面概述.
- 为了强调系统与不同胰岛素的互操作性.
主要方法:
- 分析了三项随机对照试验和五项现实调查的数据.
- 数据收集时间从2017年3月到2022年4月,涉及6859名成年患者.
- 对三种不同的胰岛素系统的系统性能评估:Vicentra Kaleido,Sooil Dana-I和罗氏洞察.
主要成果:
- 时间在70-180mg/dL的范围 (TIR) 显著改善,增加12.2-17.3个百分点 (从47.4%到56.6%).
- 低血糖症的平均时间减少了48% (范围:26%-70%),在最大的队列中达到1.3%.
- 在基线低血糖症 (≥5%) 的患者中,时间低于范围 (TBR) 减少了 59%.
结论:
- DBLG1闭环系统证明了欧洲各个国家和类型的效率,安全性和互操作性.
- 持续改善TIR和降低低血糖率证实了该系统的有效性.
- 该系统与多个设置集成的能力突出了其互操作性.
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