Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas.
Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas.
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DOI：
10.2337/dc13-2076
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发表时间：
2014-07
期刊：
影响因子：
16.2
通讯作者：
Doyle FJ 3rd
中科院分区：
文献类型：
--
作者：
Kovatchev BP;Renard E;Cobelli C;Zisser HC;Keith-Hynes P;Anderson SM;Brown SA;Chernavvsky DR;Breton MD;Mize LB;Farret A;Place J;Bruttomesso D;Del Favero S;Boscari F;Galasso S;Avogaro A;Magni L;Di Palma F;Toffanin C;Messori M;Dassau E;Doyle FJ 3rd
我们估计低血糖风险降低在闭环控制（CLC）与开环（OL）传感器增强胰岛素泵治疗在监督门诊设置的效应大小。20名1型糖尿病患者在弗吉尼亚大学、帕多瓦大学、蒙彼利埃和桑瑟姆糖尿病研究所发起了这项研究；18完成整个方案。每个病人参加了两次40小时的门诊，CLC和OL，随机顺序。传感器（Dexcom G4）和胰岛素泵（Tandem t:slim）与智能手机人工胰腺平台Diabetes Assistant （DiAs）相连。患者在CLC和OL期间均通过DiAs用户界面操作系统；研究人员在现场监督并远程监测DiAs。没有饮食限制；45分钟的城镇步行和餐馆晚餐都包含在CLC和OL中；酒精是允许的。主要结局-低血糖（BG）指数（LGBI）测量的低血糖风险降低-导致效应大小为0.64,P = 0.003，需要碳水化合物治疗的低血糖降低两倍：CLC与OL的1.2 vs 2.4次/次（P = 0.02）。与此同时，在3.9-10 mmol/L目标范围内的时间百分比略有下降（66.1 vs 70.7%）， CLC与OL的平均BG增加（8.9 vs 8.4 mmol/L, P = 0.04）。与传感器增强泵治疗相比，在门诊条件下在智能手机（DiAs）上运行的CLC降低了低血糖和低血糖治疗。这可能是由于过度强调低血糖的安全性而导致的平均血糖轻微增加。
We estimate the effect size of hypoglycemia risk reduction on closed-loop control (CLC) versus open-loop (OL) sensor-augmented insulin pump therapy in supervised outpatient setting. Twenty patients with type 1 diabetes initiated the study at the Universities of Virginia, Padova, and Montpellier and Sansum Diabetes Research Institute; 18 completed the entire protocol. Each patient participated in two 40-h outpatient sessions, CLC versus OL, in randomized order. Sensor (Dexcom G4) and insulin pump (Tandem t:slim) were connected to Diabetes Assistant (DiAs)—a smartphone artificial pancreas platform. The patient operated the system through the DiAs user interface during both CLC and OL; study personnel supervised on site and monitored DiAs remotely. There were no dietary restrictions; 45-min walks in town and restaurant dinners were included in both CLC and OL; alcohol was permitted. The primary outcome—reduction in risk for hypoglycemia as measured by the low blood glucose (BG) index (LGBI)—resulted in an effect size of 0.64, P = 0.003, with a twofold reduction of hypoglycemia requiring carbohydrate treatment: 1.2 vs. 2.4 episodes/session on CLC versus OL (P = 0.02). This was accompanied by a slight decrease in percentage of time in the target range of 3.9–10 mmol/L (66.1 vs. 70.7%) and increase in mean BG (8.9 vs. 8.4 mmol/L; P = 0.04) on CLC versus OL. CLC running on a smartphone (DiAs) in outpatient conditions reduced hypoglycemia and hypoglycemia treatments when compared with sensor-augmented pump therapy. This was accompanied by marginal increase in average glycemia resulting from a possible overemphasis on hypoglycemia safety.