美国芭芭拉戴维斯糖尿病中心R. Paul Wadwa团队研究了闭环控制治疗1型糖尿病儿童的效果。2020年8月27日，该研究发表在《新英格兰医学杂志》上。
参与者基线时的糖化血红蛋白水平为5.7％至10.1％。治疗16周后，闭环组中血糖水平在70-180 mg/dL目标范围内的时间百分比从53±17％增至67±10％，对照组则从51±16％增至55±13％，组间差异显著。两组中葡萄糖水平低于70 mg/dL的中位时间百分比均较低，其中闭环组为1.6％，对照组为1.8％。在闭环组中，系统处于闭环模式的中位时间百分比为93％。两组均未发生糖尿病酮症酸中毒或严重低血糖发作。
Title: A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes
Author: Marc D. Breton, Ph.D.,, Lauren G. Kanapka, M.Sc.,, Roy W. Beck, M.D., Ph.D.,, Laya Ekhlaspour, M.D.,, Gregory P. Forlenza, M.D.,, Eda Cengiz, M.D.,, Melissa Schoelwer, M.D.,, Katrina J. Ruedy, M.S.P.H.,, Emily Jost, M.P.H., R.D., C.D.E.,, Lori Carria, M.S.,, Emma Emory, R.N.,, Liana J. Hsu, B.S.,, Mary Oliveri, C.C.R.C.,, Craig C. Kollman, Ph.D.,, Betsy B. Dokken, Ph.D.,, Stuart A. Weinzimer, M.D.,, Mark D. DeBoer, M.D.,, Bruce A. Buckingham, M.D.,, Daniel Cheravvsky, M.D.,, and R. Paul Wadwa, M.D.
A closed-loop system of insulin delivery (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes.
In a 16-week, multicenter, randomized, open-label, parallel-group trial, we assigned, in a 3:1 ratio, children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group). The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring.
A total of 101 children underwent randomization (78 to the closed-loop group and 23 to the control group); the glycated hemoglobin levels at baseline ranged from 5.7 to 10.1%. The mean (±SD) percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter increased from 53±17% at baseline to 67±10% (the mean over 16 weeks of treatment) in the closed-loop group and from 51±16% to 55±13% in the control group (mean adjusted difference, 11 percentage points [equivalent to 2.6 hours per day]; 95% confidence interval, 7 to 14; P<0.001). In both groups, the median percentage of time that the glucose level was below 70 mg per deciliter was low (1.6% in the closed-loop group and 1.8% in the control group). In the closed-loop group, the median percentage of time that the system was in the closed-loop mode was 93% (interquartile range, 91 to 95). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.
In this 16-week trial involving children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump.
The New England Journal of Medicine：《新英格兰医学杂志》，创刊于1812年。隶属于美国麻省医学协会，最新IF：70.67