Cherñavvsky Daniel R, DeBoer Mark D, Keith-Hynes Patrick, Mize Benton, McElwee Molly, Demartini Susan, Dunsmore Spencer F, Wakeman Christian, Kovatchev Boris P, Breton Marc D
Center for Diabetes Technology, University of Virginia, Charlottesville, VA, USA.
Division of Pediatric Endocrinology, Department of Pediatrics, University of Virginia, Charlottesville, VA, USA.
Pediatr Diabetes. 2016 Feb;17(1):28-35. doi: 10.1111/pedi.12230. Epub 2014 Oct 27.
The objective of this study was to evaluate the safety and performance of the artificial pancreas (AP) in adolescents with type 1 diabetes (T1D) following insulin omission for food.
In a randomized, cross-over trial, adolescents with T1D aged 13-18 yr were enrolled in a randomized, cross-over trial. On separate days, received either usual care (UC) through their home insulin pump or used an AP system (Diabetes Assistant platform, continuous glucose monitor, and insulin pump). Approximately 1 h after admission, participants in both groups received an unannounced snack of 30 g carbohydrate, and 4 h later they received an 80 g lunch, for which both groups only received 75% of the calculated insulin dose to cover carbohydrates. On the UC day (but not the AP day), they received their full high blood glucose (BG) correction factor at lunch. Each admission lasted approximately 8 h.
A total of 16 participants completed the trial. On the AP day (compared to UC), mean BG was lower (197 ± 10 vs. 235 ± 14 mg/dL) and time in range 70-180 mg/dL was higher (43% ± 7 vs. 19% ± 7) (both p < 0.05) overall; these results held in the time following the snack and meal (also p < 0.05). During the trial, there were no differences between groups in the rate of hypoglycemia <70 mg/dL.
The AP provided improvements in short-term glycemic control without increases in hypoglycemia following missed insulin for food in adolescents. Thus, the AP partly compensates for missed insulin boluses for food, a common occurrence in adolescent diabetes care. Further testing is needed in longer-term settings.
本研究的目的是评估人工胰腺（AP）在1型糖尿病（T1D）青少年中省略食物胰岛素后的安全性和性能。
在一项随机交叉试验中，纳入了13 - 18岁的T1D青少年。在不同的日子里，他们要么通过家用胰岛素泵接受常规护理（UC），要么使用AP系统（糖尿病助手平台、连续血糖监测仪和胰岛素泵）。入院后约1小时，两组参与者均接受一份30克碳水化合物的突击零食，4小时后接受一份80克午餐，两组仅接受计算出的覆盖碳水化合物所需胰岛素剂量的75%。在UC日（而非AP日），他们在午餐时接受完整的高血糖（BG）校正因子。每次入院持续约8小时。
共有16名参与者完成了试验。总体而言，在AP日（与UC日相比），平均BG较低（197±10 vs. 235±14 mg/dL），血糖在70 - 180 mg/dL范围内的时间更长（43%±7 vs. 19%±7）（两者p<0.05）；这些结果在零食和餐后时间段也成立（p<0.05）。在试验期间，两组低血糖发生率<70 mg/dL无差异。
对于青少年而言，AP在省略食物胰岛素后可改善短期血糖控制且不会增加低血糖发生率。因此，AP部分补偿了食物胰岛素推注遗漏，这在青少年糖尿病护理中很常见。需要在更长时间的环境中进行进一步测试。
