Department of Paediatrics , Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge , Cambridge , UK.
Department of Paediatrics , Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge , Cambridge , UK ; Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead , Sydney , Australia.
BMJ Open Diabetes Res Care. 2014 Dec 11;2(1):e000040. doi: 10.1136/bmjdrc-2014-000040. eCollection 2014.
To assess feasibility of overnight closed-loop therapy in young children with type 1 diabetes and contrast closed loop using diluted versus standard insulin strength.
Eleven children (male 6; age range 3.75-6.96 years; glycated hemoglobin 60 (14) mmol/mol; body mass index SD score 1.0 (0.8); diabetes duration 2.2 (1.0) years, mean (SD); total daily dose 12.9 (10.6, 16.5) IU/day, median (IQR)) were studied at a clinical research facility on two occasions. In random order, participants received closed loop with diluted insulin aspart (CL_Dil; 20 IU/mL) or closed loop with standard aspart (CL_Std; 100 IU/mL) from 17:00 until 8:00 the following morning. Children consumed an evening meal at 17:00 (44 (12) gCHO) and an optional bedtime snack (6 (7) gCHO) identical on both occasions. Meal insulin boluses were calculated by standard pump bolus calculators. Basal rates on insulin pump were adjusted every 15 min as directed by a model-predictive-control algorithm informed by a real-time glucose sensor values.
Mean plasma glucose was 122 (24) mg/dL during CL_Dil vs 122 (23) mg/dL during CL_Std (p=0.993). The time spent in the target glucose range 70-145 mg/dL was 83 (70, 100)% vs 72 (54, 81)% (p=0.328). Time above 145 mg/dL was 13 (0, 27)% vs 19 (10, 45)% (p=0.477) and time spent below 70 mg/dL was 0.0 (0.0, 1.4)% vs 1.4 (0.0, 11.6)% (p=0.161). One asymptomatic hypoglycemia below 63 mg/dL occurred in one participant during CL_Dil versus six episodes in five participants during CL_Std (p=0.09). Glucose variability measured by CV of plasma glucose tended to be reduced during CL_Dil (20% (13, 31) vs 32% (24, 42), p=0.075).
In this feasibility study, closed-loop therapy maintained good overnight glucose control with tendency towards reduced hypoglycemia and reduced glucose variability using diluted insulin.
clinicaltrials.gov Identifier: NCT01557634.
评估在 1 型糖尿病患儿中使用 overnight closed-loop 疗法的可行性，并对比使用稀释胰岛素和标准胰岛素强度的闭环治疗。
在临床研究机构对 11 名儿童（男 6 名；年龄 3.75-6.96 岁；糖化血红蛋白 60（14）mmol/mol；体重指数标准差评分 1.0（0.8）；糖尿病病程 2.2（1.0）年，平均值（SD）；总日剂量 12.9（10.6，16.5）IU/天，中位数（IQR））进行了两次研究。随机顺序下，参与者在夜间从 17：00 至次日 8：00 接受了两种不同的闭环治疗：使用稀释胰岛素门冬氨酸（CL_Dil；20 IU/mL）的闭环治疗，或使用标准门冬氨酸（CL_Std；100 IU/mL）的闭环治疗。儿童在 17：00 时进食晚餐（44（12）gCHO），并在两次研究中都可选择吃睡前零食（6（7）gCHO）。通过标准泵推注计算器计算餐时胰岛素推注量。胰岛素泵的基础率根据实时血糖传感器值的模型预测控制算法每 15 分钟调整一次。
在 CL_Dil 期间，平均血浆葡萄糖为 122（24）mg/dL，在 CL_Std 期间为 122（23）mg/dL（p=0.993）。目标血糖范围 70-145mg/dL 的时间占比为 83（70，100）%，在 CL_Std 期间为 72（54，81）%（p=0.328）。血糖高于 145mg/dL 的时间占比为 13（0，27）%，在 CL_Std 期间为 19（10，45）%（p=0.477），血糖低于 70mg/dL 的时间占比为 0.0（0.0，1.4）%，在 CL_Std 期间为 1.4（0.0，11.6）%（p=0.161）。在 CL_Dil 期间，有 1 名参与者出现了 1 次无症状性低血糖（<63mg/dL），而在 CL_Std 期间，有 5 名参与者出现了 6 次低血糖（p=0.09）。通过血糖变异系数（CV）测量，CL_Dil 期间的血糖变异性呈下降趋势（20%（13，31）比 32%（24，42），p=0.075）。
在这项可行性研究中，闭环治疗使用稀释胰岛素维持了良好的夜间血糖控制，同时降低了低血糖和血糖变异性的风险。
clinicaltrials.gov 标识符：NCT01557634。
