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使用标准与增强型混合闭环系统控制血糖:一项随机交叉研究。

Glucose Control Using a Standard Versus an Enhanced Hybrid Closed Loop System: A Randomized Crossover Study.

机构信息

1 Department of Medicine, St. Vincent's Hospital Melbourne, University of Melbourne, Fitzroy, Australia.

2 Department of Endocrinology and Diabetes, St. Vincent's Hospital Melbourne, Fitzroy, Australia.

出版信息

Diabetes Technol Ther. 2019 Jan;21(1):56-58. doi: 10.1089/dia.2018.0279.

DOI:10.1089/dia.2018.0279
PMID:30620641
Abstract

Hybrid closed loop (HCL) insulin delivery with the Medtronic Minimed 670G system is effective and safe in people with type 1 diabetes (T1D). This study compared glucose control, closed loop (CL) exits, and alarm frequency with the standard HCL (s-HCL) versus enhanced HCL (e-HCL) Medtronic system. Pump-experienced T1D adults (n = 11; 9 female; mean [SD] age: 51 years [15 years]; HbA1c 7.5% [1.0%] or 58 mmol/mol [7.7 mmol/mol]) were assigned, in random order, s-HCL or e-HCL for 1 week each in a supervised live-in setting. e-HCL incorporated enhanced bolus reminders and iterative changes, broadening glucose and insulin delivery parameters permitting persistence in CL. For both s-HCL and e-HCL, insulin delivery was by a Medtronic pump with identical interventions (missed bolus, exercise, high-glycemic index, and high-fat meals), insulin action times, and insulin-carbohydrate ratios implemented. The primary outcome was continuous glucose monitoring time in target range. Analysis was by paired t-test for normally distributed data and Wilcoxon-signed rank test otherwise. e-HCL resulted in significantly fewer CL alerts and exits. Time in target and mean glucose favored e-HCL but did not reach statistical significance. No episodes of severe hypoglycemia or ketoacidosis occurred. Relative to s-HCL, e-HCL use significantly decreases CL exits and alerts, and tended to improve glycemia without compromising safety, despite multiple food and exercise challenges during the study. Longer term studies at home are merited.

摘要

美敦力 670G 系统的混合闭环 (HCL) 胰岛素输送在 1 型糖尿病 (T1D) 患者中是有效且安全的。本研究比较了标准 HCL (s-HCL) 与增强型 HCL (e-HCL) 美敦力系统的血糖控制、闭环 (CL) 退出和报警频率。泵经验丰富的 T1D 成年患者 (n=11; 9 名女性; 平均 [SD] 年龄:51 岁 [15 年];HbA1c 7.5% [1.0%]或 58mmol/mol [7.7mmol/mol]) 以随机顺序分别接受 1 周的 s-HCL 或 e-HCL 治疗,均在监督下进行现场居住设置。e-HCL 纳入了增强型推注提醒和迭代更改,扩大了血糖和胰岛素输送参数,允许在 CL 中持续进行。对于 s-HCL 和 e-HCL,胰岛素输送均由美敦力泵进行,干预措施相同(漏注、运动、高血糖指数和高脂肪餐)、胰岛素作用时间和胰岛素碳水化合物比例相同。主要结局是目标范围内的连续血糖监测时间。正态分布数据的分析采用配对 t 检验,否则采用 Wilcoxon 符号秩检验。e-HCL 导致 CL 警报和退出明显减少。目标时间和平均血糖有利于 e-HCL,但未达到统计学意义。研究期间未发生严重低血糖或酮症酸中毒事件。与 s-HCL 相比,e-HCL 的使用显著降低了 CL 退出和警报,并且倾向于改善血糖,同时不影响安全性,尽管在研究期间进行了多次食物和运动挑战。需要进行更长期的家庭研究。

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