Home use of closed-loop insulin delivery for overnight glucose control in adults with type 1 diabetes: a 4-week, multicentre, randomised crossover study.
Home use of closed-loop insulin delivery for overnight glucose control in adults with type 1 diabetes: a 4-week, multicentre, randomised crossover study.
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DOI：
10.1016/s2213-8587(14)70114-7
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发表时间：
2014-09
影响因子：
44.5
通讯作者：
Hovorka, Roman
中科院分区：
文献类型：
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作者：
Thabit, Hood;Lubina-Solomon, Alexandra;Stadler, Marietta;Leelarathna, Lalantha;Walkinshaw, Emma;Pernet, Andrew;Allen, Janet M.;Iqbal, Ahmed;Choudhary, Pratik;Kumareswaran, Kavita;Nodale, Marianna;Nisbet, Chloe;Wilinska, Malgorzata E.;Barnard, Katharine D.;Dunger, David B.;Heller, Simon R.;Amiel, Stephanie A.;Evans, Mark L.;Hovorka, Roman
我们评估了在家过夜使用自动闭环胰岛素输送（人工胰腺）是否可以改善血糖控制。我们在一项多中心交叉研究设计中研究了 24 名患有 1 型糖尿病的成年人，比较了使用模型预测控制算法指导胰岛素输送的 4 周过夜闭环治疗与 4 周的胰岛素泵治疗，其中参与者使用独立于泵的实时显示连续血糖监测作为对照。主要结果是午夜至 07:00 期间血糖处于 3·9 和 8·0mmol/l 目标范围内的时间。分析是按意向治疗进行的。试验注册 ClinicalTrials.gov NCT01440140。在 555 个晚上（86%），闭环的使用时间中位数为 8·3（四分位数间距 6·0、9·6）小时。与对照相比，闭环期间过夜血糖处于目标范围内的时间比例显着增加 13·5%（95% CI，7·3–19·7；p<0·001）。闭环期间，平均过夜血糖（8·2±0·9 vs. 9·0±1·3mmol/l；p=0·005）和高于目标的时间（44·3%±11·9 vs. 57·1%±15·6；p=0·001）显着降低。低于目标的时间较低且具有可比性 [1·8%(0·6, 3·6) vs. 2·1%(0·7, 3·9)； p=0·28]。夜间平均血糖降低是通过增加隔夜胰岛素输送量[6·4 (4·5, 8·1) vs. 4·9 (3·7, 6·3) 单位； p<0·001) 不改变每日总胰岛素量 [34·5 (29·3, 48·4) vs. 35·4 (29·7, 45·2) 单位； p=0·32]。控制期间未发生严重低血糖事件，闭环期间发生两次与算法指令无关的事件。在家中无人监督的过夜闭环是可行的，并且可以改善 1 型糖尿病成人患者的血糖控制。
We assessed whether overnight home use of automated closed loop insulin delivery (artificial pancreas) improves glucose control. We studied 24 adults with type 1 diabetes in a multicentre crossover study design comparing four weeks of overnight closed loop using a model predictive control algorithm to direct insulin delivery, with four weeks of insulin pump therapy in which participants used real-time display of continuous glucose monitoring independent of their pumps as control. Primary outcome was time when glucose was in the target range of 3·9 and 8·0mmol/l between midnight to 07:00. Analyses were by intention to treat. Trial registration ClinicalTrials.gov NCT01440140. Closed loop was utilised over median 8·3 (interquartile range 6·0, 9·6)hours on 555nights (86%). Proportion of time when overnight glucose was in target range was significantly higher during closed loop compared to control by 13·5% (95% CI, 7·3–19·7; p<0·001). Mean overnight glucose (8·2±0·9 vs. 9·0±1·3mmol/l; p=0·005) and time spent above target (44·3%±11·9 vs. 57·1%±15·6; p=0·001) were significantly lower during closed loop. Time spent below target was low and comparable [1·8%(0·6, 3·6) vs. 2·1%(0·7, 3·9); p=0·28]. Lower mean overnight glucose was brought about by increased overnight insulin delivery [6·4 (4·5, 8·1) vs. 4·9 (3·7, 6·3)units; p<0·001) without changing the total daily insulin amount [34·5 (29·3, 48·4) vs. 35·4 (29·7, 45·2)units; p=0·32]. No severe hypoglycaemia episodes occurred during control period and two during closed loop not related to algorithm instructions. Unsupervised overnight closed loop at home is feasible and may improve glucose control in adults with type 1 diabetes.