Feasibility of outpatient fully integrated closed-loop control: first studies of wearable artificial pancreas.
Feasibility of outpatient fully integrated closed-loop control: first studies of wearable artificial pancreas.
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DOI：
10.2337/dc12-1965
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发表时间：
2013-07
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;Farret A;Pelletier MJ;Place J;Bruttomesso D;Del Favero S;Visentin R;Filippi A;Scotton R;Avogaro A;Doyle FJ 3rd
为了评估可穿戴式人工胰腺系统的可行性，糖尿病助手(DIAS)使用智能手机作为闭环控制平台。20名1型糖尿病患者在帕多瓦大学、蒙彼利埃大学、弗吉尼亚大学和桑苏姆糖尿病研究所登记。每个试验持续42小时。美国的研究完全在门诊环境中进行(例如，酒店或招待所)；意大利和法国的研究是医院-酒店混合入院。将连续血糖监测/泵系统(Dexcom Seven Plus/OmniPod)放置在受试者身上，并连接到DIAS。患者通过DIAS用户界面在开环模式下(研究的前14小时)操作系统，在剩下的28小时内切换到闭环系统。研究人员通过3G或WiFi连接到DIAS进行远程监控，并可在现场获得帮助。系统通讯功能正常的总持续时间为807.5 h(开环274h，闭合533.5 h)，占从入院到出院总可能时间的97.7%。这超过了预定的80%系统功能的主要终结点。这项研究证明了当代智能手机能够运行门诊闭环控制，并介绍了一个原型系统(DIAS)以供进一步研究。根据这一概念验证，未来的步骤应该包括配备具有无线功能的胰岛素泵和传感器，以及侧重于控制效果和以患者为导向的临床结果的研究。
To evaluate the feasibility of a wearable artificial pancreas system, the Diabetes Assistant (DiAs), which uses a smart phone as a closed-loop control platform. Twenty patients with type 1 diabetes were enrolled at the Universities of Padova, Montpellier, and Virginia and at Sansum Diabetes Research Institute. Each trial continued for 42 h. The United States studies were conducted entirely in outpatient setting (e.g., hotel or guest house); studies in Italy and France were hybrid hospital–hotel admissions. A continuous glucose monitoring/pump system (Dexcom Seven Plus/Omnipod) was placed on the subject and was connected to DiAs. The patient operated the system via the DiAs user interface in open-loop mode (first 14 h of study), switching to closed-loop for the remaining 28 h. Study personnel monitored remotely via 3G or WiFi connection to DiAs and were available on site for assistance. The total duration of proper system communication functioning was 807.5 h (274 h in open-loop and 533.5 h in closed-loop), which represented 97.7% of the total possible time from admission to discharge. This exceeded the predetermined primary end point of 80% system functionality. This study demonstrated that a contemporary smart phone is capable of running outpatient closed-loop control and introduced a prototype system (DiAs) for further investigation. Following this proof of concept, future steps should include equipping insulin pumps and sensors with wireless capabilities, as well as studies focusing on control efficacy and patient-oriented clinical outcomes.
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