Randomized Summer Camp Crossover Trial in 5-to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe
Randomized Summer Camp Crossover Trial in 5-to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe
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DOI：
10.2337/dc15-2815
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发表时间：
2016-07-01
期刊：
影响因子：
16.2
通讯作者：
Bruttomesso, Daniela
中科院分区：
文献类型：
--
作者：
Del Favero, Simone;Boscari, Federico;Bruttomesso, Daniela
目的 儿科人工胰腺 (PedArPan) 项目在训练营期间对 5 至 9 岁儿童测试了儿童专用版本的模块化模型预测控制 (MMPC) 算法。 研究设计和方法 共有 30 名 5 至 9 岁 1 型糖尿病儿童完成了一项门诊、开放标签、随机、交叉试验。将三天的人工胰腺 (AP) 与三天的父母管理传感器增强泵 (SAP) 进行比较。 结果 与 SAP 相比，AP 的夜间低血糖时间缩短，中位数（第 25-75 个百分位数）：0.0% (0.0-2.2) 与 2.2% (0.0-12.3) (P = 0.002)，但没有显着变化目标时间平均值：56.0% (SD 22.5) vs. 59.7% (21.2) (P = 0.430)，但平均血糖增加为 173 mg/dL (36) vs. 150 mg/dL (39) (P = 0.002)。总体而言，AP 将低血糖时间缩短了三倍 (P < 0.001)，但代价是目标时间缩短了 56.8% (13.5) 与 63.1% (11.0) (P = 0.022)，并且平均血糖增加了 169 mg/dL (23) vs. 147 mg/dL (23) (P < 0.001).结论该试验是该年龄段人群中第一个门诊单激素 AP 试验，显示了 MMPC 在幼儿中的可行性和安全性。将进行算法重新调整以提高效率。
OBJECTIVEThe Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5-to 9-year-old children during a camp.RESEARCH DESIGN AND METHODSA total of 30 children, 5-to 9-years old, with type 1 diabetes completed an outpatient, open-label, randomized, crossover trial. Three days with an artificial pancreas (AP) were compared with three days of parent-managed sensor-augmented pump (SAP).RESULTSOvernight time-in-hypoglycemia was reduced with the AP versus SAP, median (25th-75th percentiles): 0.0% (0.0-2.2) vs. 2.2% (0.0-12.3) (P = 0.002), without a significant change of time-in-target, mean: 56.0% (SD 22.5) vs. 59.7% (21.2) (P = 0.430), but with increased mean glucose 173 mg/dL (36) vs. 150 mg/dL (39) (P = 0.002). Overall, the AP granted a threefold reduction of time-in-hypoglycemia (P < 0.001) at the cost of decreased time-in-target, 56.8% (13.5) vs. 63.1% (11.0) (P = 0.022) and increased mean glucose 169 mg/dL (23) vs. 147 mg/dL (23) (P < 0.001).CONCLUSIONSThis trial, the first outpatient single-hormone AP trial in a population of this age, shows feasibility and safety of MMPC in young children. Algorithm retuning will be performed to improve efficacy.