Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes.
Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes.
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DOI：
10.1089/dia.2016.0421
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发表时间：
2017-03
影响因子：
5.4
通讯作者：
Kaufman FR
中科院分区：
文献类型：
--
作者：
Garg SK;Weinzimer SA;Tamborlane WV;Buckingham BA;Bode BW;Bailey TS;Brazg RL;Ilany J;Slover RH;Anderson SM;Bergenstal RM;Grosman B;Roy A;Cordero TL;Shin J;Lee SW;Kaufman FR
背景资料：研究了在家中使用混合闭环（HCL）系统的安全性和有效性，该系统可自动增加、减少和暂停胰岛素输注，以响应持续葡萄糖监测。研究方法：1型糖尿病青少年（n = 30，年龄14-21岁）和成人（n = 94，年龄22-75岁）参加了一项多中心（美国9个研究中心，以色列1个研究中心）关键试验。Medtronic MiniMed® 670 G系统在2周导入期内使用，未启用HCL控制或自动模式（手动模式），此后在3个月研究期内启用自动模式。在研究期间，受监督的酒店住宿（6天/5晚）包括24小时频繁的血液样本检测和参考测量（i-STAT）。结果如下：青少年（平均值±标准差[SD] 16.5 ± 2.29岁，糖尿病7.7 ± 4.15岁）使用该系统的时间中位数为75.8%（四分位距[IQR] 68.0%-88.4%）（2977患者-天）。成人（平均± SD 44.6 ± 12.79岁，糖尿病26.4 ± 12.43岁）使用系统的时间中位数为88.0%（IQR 77.6%-92.7%）（9412患者-天）。从基线导入至研究期结束，青少年和成人HbA 1c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）。青少年中总体目标内（71-180 mg/dL）探头葡萄糖（SG）值的比例从60.4% ± 10.9%增加到67.2% ± 8.2%（P < 0.001），成人中从68.8% ± 11.9%增加到73.8% ± 8.4%（P < 0.001）。在酒店住宿期间，青少年中目标i-STAT®血糖值的比例为67.4% ± 27.7%，而SG值为72.0% ± 11.6%，成人中目标i-STAT ®血糖值的比例为74.2% ± 17.5%，而成人中目标血糖值的比例为76.9% ± 8.3%。两个队列均未发生重度低血糖或糖尿病酮症酸中毒事件。结论：HCL治疗在青少年和成人家庭使用期间是安全的，研究阶段显示，与基线相比，达到目标的时间延长，HbA 1c、高血糖症和低血糖症降低。试验注册：标识符：NCT 02463097。
Background: 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. Methods: 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. Results: 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 HbA1c 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. Conclusions: HCL therapy was safe during in-home use by adolescents and adults and the study phase demonstrated increased time in target, and reductions in HbA1c, hyperglycemia and hypoglycemia, compared to baseline. Trial Registration: identifier: NCT02463097.