Garg Satish K, Weinzimer Stuart A, Tamborlane William V, Buckingham Bruce A, Bode Bruce W, Bailey Timothy S, Brazg Ronald L, Ilany Jacob, Slover Robert H, Anderson Stacey M, Bergenstal Richard M, Grosman Benyamin, Roy Anirban, Cordero Toni L, Shin John, Lee Scott W, Kaufman Francine R
1 Barbara Davis Center for Diabetes, University of Colorado Denver , Aurora, Colorado.
2 Yale University , New Haven, Connecticut.
Diabetes Technol Ther. 2017 Mar;19(3):155-163. doi: 10.1089/dia.2016.0421. Epub 2017 Jan 30.
The safety and effectiveness of the in-home use of a hybrid closed-loop (HCL) system that automatically increases, decreases, and suspends insulin delivery in response to continuous glucose monitoring were investigated.
Adolescents (n = 30, ages 14-21 years) and adults (n = 94, ages 22-75 years) with type 1 diabetes participated in a multicenter (nine sites in the United States, one site in Israel) pivotal trial. The Medtronic MiniMed 670G system was used during a 2-week run-in phase without HCL control, or Auto Mode, enabled (Manual Mode) and, thereafter, with Auto Mode enabled during a 3-month study phase. A supervised hotel stay (6 days/5 nights) that included a 24-h frequent blood sample testing with a reference measurement (i-STAT) occurred during the study phase.
Adolescents (mean ± standard deviation [SD] 16.5 ± 2.29 years of age and 7.7 ± 4.15 years of diabetes) used the system for a median 75.8% (interquartile range [IQR] 68.0%-88.4%) of the time (2977 patient-days). Adults (mean ± SD 44.6 ± 12.79 years of age and 26.4 ± 12.43 years of diabetes) used the system for a median 88.0% (IQR 77.6%-92.7%) of the time (9412 patient-days). From baseline run-in to the end of study phase, adolescent and adult HbA levels decreased from 7.7% ± 0.8% to 7.1% ± 0.6% (P < 0.001) and from 7.3% ± 0.9% to 6.8% ± 0.6% (P < 0.001, Wilcoxon signed-rank test), respectively. The proportion of overall in-target (71-180 mg/dL) sensor glucose (SG) values increased from 60.4% ± 10.9% to 67.2% ± 8.2% (P < 0.001) in adolescents and from 68.8% ± 11.9% to 73.8% ± 8.4% (P < 0.001) in adults. During the hotel stay, the proportion of in-target i-STAT blood glucose values was 67.4% ± 27.7% compared to SG values of 72.0% ± 11.6% for adolescents and 74.2% ± 17.5% compared to 76.9% ± 8.3% for adults. There were no severe hypoglycemic or diabetic ketoacidosis events in either cohort.
HCL therapy was safe during in-home use by adolescents and adults and the study phase demonstrated increased time in target, and reductions in HbA hyperglycemia and hypoglycemia, compared to baseline.
Clinicaltrials.gov identifier: NCT02463097.
研究了一种混合闭环（HCL）系统在家中使用时的安全性和有效性，该系统可根据持续葡萄糖监测自动增加、减少和暂停胰岛素输注。
1型糖尿病青少年（n = 30，年龄14 - 21岁）和成年人（n = 94，年龄22 - 75岁）参与了一项多中心（美国9个地点，以色列1个地点）的关键试验。美敦力MiniMed 670G系统在为期2周的导入期使用，期间未启用HCL控制或自动模式（手动模式），此后，在为期3个月的研究期内启用自动模式。在研究期内安排了一次有监督的酒店住宿（6天/5晚），包括使用参考测量设备（i-STAT）进行24小时频繁血样检测。
青少年（平均±标准差[SD]，年龄16.5±2.29岁，糖尿病病程7.7±4.15年）使用该系统的时间中位数为75.8%（四分位间距[IQR] 68.0% - 88.4%）（2977患者日）。成年人（平均±SD，年龄44.6±12.79岁，糖尿病病程26.4±12.43年）使用该系统的时间中位数为88.0%（IQR 77.6% - 92.7%）（9412患者日）。从基线导入期到研究期结束，青少年和成年人的糖化血红蛋白（HbA）水平分别从7.7%±0.8%降至7.1%±0.6%（P < 0.001）和从7.3%±0.9%降至6.8%±0.6%（P < 0.001，Wilcoxon符号秩检验）。青少年总体目标范围内（71 - 180mg/dL）的传感器葡萄糖（SG）值比例从60.4%±10.9%增至67.2%±8.2%（P < 0.001），成年人从68.8%±11.9%增至73.8%±8.4%（P < 0.001）。在酒店住宿期间，青少年目标范围内的i-STAT血糖值比例为67.4%±27.7%，而SG值为72.0%±11.6%；成年人目标范围内的i-STAT血糖值比例为74.2%±17.5%，而SG值为76.9%±8.3%。两个队列均未发生严重低血糖或糖尿病酮症酸中毒事件。
HCL疗法在青少年和成年人在家中使用时是安全的，与基线相比，研究期显示目标时间增加，HbA、高血糖和低血糖有所降低。
Clinicaltrials.gov标识符：NCT02463097。
