DeBoer Mark D, Breton Marc D, Wakeman Christian, Schertz Elaine M, Emory Emma G, Robic Jessica L, Kollar Laura L, Kovatchev Boris P, Cherñavvsky Daniel R
1 Center for Diabetes Technology, University of Virginia , Charlottesville, Virginia.
2 Division of Pediatric Endocrinology, Department of Pediatrics, University of Virginia , Charlottesville, Virginia.
Diabetes Technol Ther. 2017 May;19(5):293-298. doi: 10.1089/dia.2016.0424. Epub 2017 Apr 20.
Young children 5-8 years old with type 1 diabetes (T1D) exhibit clear needs for improved glycemic control but may be limited in their ability to safely interact with an artificial pancreas system. Our goal was to evaluate the safety and performance of an artificial pancreas (AP) system among young children with T1D.
In a randomized, crossover trial, children with T1D age 5-8 years were enrolled to receive on separate study periods (in random order) either the UVa AP using the DiAs Control Platform software with child-resistant lock-out screens (followed as an out-patient admission) or their usual insulin pump+continuous glucose monitor (CGM) care at home. Hypoglycemic events and CGM tracings were compared between the two 68-h study periods. All analyses were adjusted for level of physical activity as tracked using Fitbit devices.
Twelve participants (median age 7 years, n = 6 males) completed the trial. Compared to home care, the AP admission resulted in increased time with blood glucose (BG) 70-180 mg/dL (73% vs. 47%) and lower mean BG (152 mg/dL vs. 190 mg/dL), both P < 0.001 after adjustment for activity. Occurrence of hypoglycemia was similar between sessions without differences in time <70 mg/dL (AP 1.1% ± 1.1%; home 1.6% ± 1.2%). There were no adverse events during the AP or home study periods.
Use of an AP in young children was safe and resulted in improved mean BG without increased hypoglycemia. This suggests that AP use in young children is safe and improves overall diabetes control. ClinicalTrials.gov registration number: NCT02750267.
5至8岁的1型糖尿病（T1D）幼儿表现出改善血糖控制的明确需求，但他们与人工胰腺系统安全互动的能力可能有限。我们的目标是评估人工胰腺（AP）系统在T1D幼儿中的安全性和性能。
在一项随机交叉试验中，招募了5至8岁的T1D儿童，让他们在不同的研究阶段（随机顺序）分别接受使用带有儿童安全锁定屏幕的DiAs Control平台软件的弗吉尼亚大学AP（作为门诊入院随访）或在家中接受常规胰岛素泵+连续血糖监测（CGM）护理。比较两个68小时研究阶段的低血糖事件和CGM记录。所有分析均根据使用Fitbit设备跟踪的身体活动水平进行调整。
12名参与者（中位年龄7岁，n = 6名男性）完成了试验。与家庭护理相比，AP入院导致血糖（BG）在70-180mg/dL的时间增加（73%对47%），平均BG降低（152mg/dL对190mg/dL），调整活动后两者P均<0.001。低血糖的发生率在各阶段相似，<70mg/dL的时间无差异（AP为1.1%±1.1%；家庭为1.6%±1.2%）。在AP或家庭研究期间没有不良事件。
在幼儿中使用AP是安全的，可改善平均BG且不增加低血糖。这表明在幼儿中使用AP是安全的，并可改善整体糖尿病控制。ClinicalTrials.gov注册号：NCT02750267。
