Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.
Department of Paediatrics, University of Cambridge, Cambridge, U.K.
Diabetes Care. 2019 Apr;42(4):594-600. doi: 10.2337/dc18-1881. Epub 2019 Jan 28.
We aimed to assess the feasibility and safety of hybrid closed-loop insulin delivery in children with type 1 diabetes aged 1-7 years as well as evaluate the role of diluted insulin on glucose control.
In an open-label, multicenter, multinational, randomized crossover study, 24 children with type 1 diabetes on insulin pump therapy (median age 5 years [interquartile range 3-6] and mean ± SD HbA 7.4 ± 0.7% [57 ± 8 mmol/mol] and total insulin 13.2 ± 4.8 units/day) underwent two 21-day periods of unrestricted living and we compared hybrid closed-loop with diluted insulin (U20) and hybrid closed-loop with standard strength insulin (U100) in random order. During both interventions, the Cambridge model predictive control algorithm was used.
The proportion of time that sensor glucose was in the target range between 3.9 and 10 mmol/L (primary end point) was not different between interventions (mean ± SD 72 ± 8% vs. 70 ± 7% for closed-loop with diluted insulin vs. closed-loop with standard insulin, respectively; = 0.16). There was no difference in mean glucose levels (8.0 ± 0.8 vs. 8.2 ± 0.6 mmol/L; = 0.14), glucose variability (SD of sensor glucose 3.1 ± 0.5 vs. 3.2 ± 0.4 mmol/L; = 0.16), or the proportion of time spent with sensor glucose <3.9 mmol/L (4.5 ± 1.7% vs. 4.7 ± 1.4%; = 0.47) or <2.8 mmol/L (0.6 ± 0.5% vs. 0.6 ± 0.4%; > 0.99). Total daily insulin delivery did not differ (17.3 ± 5.6 vs. 18.9 ± 6.9 units/day; = 0.07). No closed-loop-related severe hypoglycemia or ketoacidosis occurred.
Unrestricted home use of day-and-night closed-loop in very young children with type 1 diabetes is feasible and safe. The use of diluted insulin during closed-loop does not provide additional benefits compared with standard strength insulin.
评估 1-7 岁 1 型糖尿病儿童使用混合闭环胰岛素输注的可行性和安全性，并评价稀释胰岛素对血糖控制的作用。
这是一项多中心、多国、开放标签、随机交叉研究，24 名接受胰岛素泵治疗的 1 型糖尿病儿童（中位年龄 5 岁[四分位距 3-6]，平均 ± 标准差 HbA1c 7.4 ± 0.7%[57 ± 8 mmol/mol]和总胰岛素 13.2 ± 4.8 单位/天）进行了为期 21 天的不受限制的生活，我们比较了混合闭环与稀释胰岛素（U20）和混合闭环与标准强度胰岛素（U100）的随机顺序。在这两种干预措施中，均使用了剑桥模型预测控制算法。
传感器血糖在 3.9-10 mmol/L 目标范围内的时间比例（主要终点）在两种干预措施之间无差异（分别为闭环与稀释胰岛素组 72 ± 8%和闭环与标准胰岛素组 70 ± 7%； = 0.16）。平均血糖水平（8.0 ± 0.8 vs. 8.2 ± 0.6 mmol/L； = 0.14）、血糖变异性（传感器血糖标准差 3.1 ± 0.5 vs. 3.2 ± 0.4 mmol/L； = 0.16）或传感器血糖 <3.9 mmol/L 的时间比例（4.5 ± 1.7% vs. 4.7 ± 1.4%； = 0.47）或 <2.8 mmol/L（0.6 ± 0.5% vs. 0.6 ± 0.4%； > 0.99）也无差异。每日总胰岛素输注量无差异（17.3 ± 5.6 vs. 18.9 ± 6.9 单位/天； = 0.07）。没有与闭环相关的严重低血糖或酮症酸中毒发生。
在非常年幼的 1 型糖尿病儿童中，不限制地在家使用日夜混合闭环是可行和安全的。与标准强度胰岛素相比，闭环期间使用稀释胰岛素并没有提供额外的益处。
