Pei Yu, Ke Weijian, Lu Jing, Lin Yi, Zhang Zhijian, Peng Yongde, Bi Yan, Li Yanbing, Hou Jue, Zhang Xiaolu, Chen Xiaoxiao, Treminio Yuri, Lee Scott W, Shin John, Rhinehart Andrew S, Vigersky Robert A, Mu Yiming
Chinese PLA General Hospital, Beijing, China.
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Diabetes Technol Ther. 2023 Oct;25(10):718-725. doi: 10.1089/dia.2023.0234. Epub 2023 Sep 5.
While evidence supports glycemic control benefits for individuals with type 1 diabetes mellitus (T1DM) using hybrid closed-loop (HCL) systems, HCL automated insulin delivery therapy in China has not been assessed. This study evaluated safety events and effectiveness during HCL system use by Chinese adolescents and adults with T1DM. Sixty-two participants ( = 12 adolescents with a mean ± standard deviation [SD] of 15.5 ± 1.1 years and = 50 adults [mean ± SD of 37.6 ± 11.1 years]) with T1DM and baseline A1C of 7.1% ± 1.0% underwent a run-in period (∼2 weeks) using open-loop Manual Mode (sensor-augmented pump) insulin delivery with the MiniMed™ 770G system with the Guardian™ Sensor (3) glucose sensor, followed by a study period (4 weeks) with HCL Auto Mode enabled. Analyses compared continuous glucose monitoring data and insulin delivered during the run-in versus study period (Wilcoxon signed-rank test or -test). Safety events included rates of severe hypoglycemia and diabetic ketoacidosis (DKA). Compared to baseline run-in, overall Auto Mode use increased time in range (TIR, 70-180 mg/dL) from 75.3% to 80.9% ( < 0.001) and reduced time below range (TBR, <70 mg/dL) from 4.7% to 2.2% ( < 0.001). Subgroup analysis demonstrated that participants ( = 29) with baseline A1C <7.0% had TBR that reduced from 5.6% to 2.0%, while participants ( = 21) with baseline A1C ≥7.5% had time above range (TAR, >180 mg/dL) that reduced from 31.6% to 20.8%. Auto Mode use also increased the percentage achieving combined recommendations for time at sensor glucose ranges (i.e., TIR of >70%, TBR of <4% and TAR of <25%) from 24.2% at baseline to 77.4% at study end. Total daily insulin dose reduced from 42.8 ± 19.8 to 40.7 ± 18.9 U ( = 0.013). There were no severe hypoglycemic, DKA, or serious adverse events. Chinese adolescents and adults, some of whom met target A1C at baseline, safely achieved significantly improved glycemia with 1 month of MiniMed 770G system use when compared to open-loop insulin delivery. ClinicalTrials.gov ID: NCT04663295.
虽然有证据支持使用混合闭环（HCL）系统对1型糖尿病（T1DM）患者进行血糖控制有益，但HCL自动胰岛素给药疗法在中国尚未得到评估。本研究评估了中国青少年和成人T1DM患者使用HCL系统期间的安全事件和有效性。62名T1DM患者（12名青少年，平均年龄±标准差[SD]为15.5±1.1岁；50名成人，平均年龄±SD为37.6±11.1岁），基线糖化血红蛋白（A1C）为7.1%±1.0%，使用带有Guardian™ Sensor（3）葡萄糖传感器的MiniMed™ 770G系统，通过开环手动模式（传感器增强泵）胰岛素给药进行为期约2周的导入期，随后启用HCL自动模式进行为期4周的研究期。分析比较了导入期与研究期的连续血糖监测数据和胰岛素给药量（Wilcoxon符号秩检验或t检验）。安全事件包括严重低血糖和糖尿病酮症酸中毒（DKA）的发生率。与基线导入期相比，总体自动模式使用使血糖在目标范围内（TIR，70 - 180mg/dL）的时间从75.3%增加到80.9%（P < 0.001），并使血糖低于目标范围（TBR，<70mg/dL）的时间从4.7%减少到2.2%（P < 0.001）。亚组分析表明，基线A1C < 7.0%的参与者（n = 29）的TBR从5.6%降至2.0%，而基线A1C≥7.5%的参与者（n = 21）血糖高于目标范围（TAR，>180mg/dL）的时间从31.6%降至20.8%。自动模式使用还使达到传感器血糖范围综合建议（即TIR > 70%、TBR < 4%和TAR < 25%）的百分比从基线时的24.2%提高到研究结束时的77.4%。每日胰岛素总剂量从42.8±19.8单位降至40.7±18.9单位（P = 0.013）。未发生严重低血糖、DKA或严重不良事件。与开环胰岛素给药相比，中国青少年和成人在使用MiniMed 770G系统1个月后，部分患者在基线时达到了目标A1C，安全地实现了血糖的显著改善。临床试验注册号：NCT04663295。
