Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes

作者：Satish K. Garg, Stuart A. Weinzimer, William V. Tamborlane, Bruce A. Buckingham, Bruce W. Bode, Timothy S. Bailey, Ronald Brazg, Jacob Ilany, Robert H. Slover, Stacey M. Anderson, Richard M. Bergenstal, Benyamin Grosman, Anirban Roy, Toni L. Cordero, John Shin, Scott W. Lee, Francine Kaufman · 发表于：Diabetes Technology & Therapeutics · 年份：2017 · DOI：10.1089/dia.2016.0421 · 被引用次数：585 · 研究领域：Diabetes Management and Research、Hyperglycemia and glycemic control in critically ill and hospitalized patients、Diabetes and associated disorders

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 HbA 1c 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 in...