Department of Medicine, University of Melbourne, Melbourne, Australia.
Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Melbourne, Australia.
Diabetes Technol Ther. 2019 Sep;21(9):499-506. doi: 10.1089/dia.2019.0120. Epub 2019 Jul 2.
Experience from first-generation closed-loop (CL) systems informs refinements to enhance glucose control and user acceptance. A next-generation prototype enhanced-hybrid CL (E-HCL) system incorporates iterative changes to the Medtronic MiniMed 670G CL system, including automated correction boluses, lower target glucose level, and user enhancements. The aim was to explore safety, system performance, and glucose control using E-HCL in adults with type 1 diabetes. Twelve adults underwent this first in-human feasibility study. After a 1-week run-in using open-loop (OL), E-HCL was activated at the start of a supervised 1-week hotel phase, followed by 3 weeks free living at home. Supervised challenges included two meal interventions (unannounced and late meal bolus) and a sensor calibration intervention. Primary outcome was sensor glucose time-in-range (TIR); OL run-in and E-HCL at home were compared by Wilcoxon signed-rank test. Twelve adults (seven men; median [interquartile range] age 48 [39, 57] years; HbA 6.8 [6.2, 7.2]%, 51 [44, 55] mmol/mol; diabetes duration 31 [13, 41] years) completed the protocol. E-HCL resulted in greater TIR (85.3 [79.4, 88.4]% vs. 75.0 [66.6, 83.7]%, = 0.003) and lower mean sensor glucose (123.0 [119.3, 129.6] mg/dL vs. 143.5 [135.8, 154.5] mg/dL, = 0.002) than OL. Time spent <70 mg/dL increased using E-HCL (4.4 [3.3, 6.1]% vs. 3.0 [1.8, 3.8]%, = 0.02) with no difference in time <54 mg/dL ( = 0.64). Time in CL was 99.98 [99.0, 100.0]%. All participants were satisfied using E-HCL. In adults with well-controlled HbA levels, a prototype E-HCL resulted in high TIR, few CL exits, and positive user experiences at the expense of increased hypoglycemia (<70 mg/dL). E-HCL represents a positive step in the journey toward optimizing glucose control in people living with type 1 diabetes.
经验来自第一代闭环（CL）系统，这些经验有助于改进以提高血糖控制和用户接受度。下一代原型增强型混合 CL（E-HCL）系统对美敦力 MiniMed 670G CL 系统进行了迭代更改，包括自动校正推注、更低的目标血糖水平和用户增强功能。目的是探索使用 E-HCL 在 1 型糖尿病成人中的安全性、系统性能和血糖控制。 12 名成年人参加了这项首次人体可行性研究。在使用开环（OL）进行 1 周的预试验后，E-HCL 在监督的 1 周酒店入住阶段开始时激活，随后在家中自由生活 3 周。监督挑战包括两次进餐干预（未通知和延迟进餐推注）和传感器校准干预。主要结局是传感器血糖时间在范围内（TIR）；通过 Wilcoxon 符号秩检验比较 OL 预试验和 E-HCL 在家中的情况。 12 名成年人（7 名男性；中位[四分位间距]年龄 48[39,57]岁；HbA 6.8[6.2,7.2]%，51[44,55]mmol/mol；糖尿病病程 31[13,41]年）完成了该方案。E-HCL 导致更高的 TIR（85.3[79.4,88.4]%与 75.0[66.6,83.7]%， = 0.003）和更低的平均传感器血糖（123.0[119.3,129.6]mg/dL 与 143.5[135.8,154.5]mg/dL， = 0.002）比 OL。使用 E-HCL 时，<70mg/dL 的时间增加（4.4[3.3,6.1]%与 3.0[1.8,3.8]%， = 0.02），而<54mg/dL 的时间没有差异（ = 0.64）。CL 时间为 99.98[99.0,100.0]%。所有参与者对使用 E-HCL 感到满意。 在血糖控制良好的成年人中，原型 E-HCL 可实现高 TIR、较少的 CL 退出和积极的用户体验，代价是增加低血糖（<70mg/dL）。E-HCL 是朝着优化 1 型糖尿病患者血糖控制迈出的积极一步。
