Fully Closed-Loop Multiple Model Probabilistic Predictive Controller Artificial Pancreas Performance in Adolescents and Adults in a Supervised Hotel Setting
Fully Closed-Loop Multiple Model Probabilistic Predictive Controller Artificial Pancreas Performance in Adolescents and Adults in a Supervised Hotel Setting
复制标题
DOI：
10.1089/dia.2017.0424
复制
发表时间：
2018-04-16
影响因子：
5.4
通讯作者：
Buckingham, Bruce A.
中科院分区：
文献类型：
--
作者：
Forlenza, Gregory P.;Cameron, Faye M.;Buckingham, Bruce A.
背景：食品和药物管理局最初批准的人工胰腺(AP)系统将是混合型闭环系统，需要餐前公告，不会消除餐前胰岛素剂量的负担。多模型概率预测控制(MMPPC)是一个完全闭环系统，它使用对膳食的概率估计来实现自动膳食检测。在这项研究中，我们描述了MMPPC系统的安全性和性能，其中包括在有监督的酒店环境中宣布和未宣布的餐点。研究设计和方法：基于Android手机的远程监控AP系统在三个临床地点的六名成年人和四名青少年中进行了72小时的测试，每天锻炼和进餐挑战包括三种已宣布的(患者手动推注)和六种未宣布的(不按患者推注)膳食。安全标准是预先定义的。根据既往的低血糖事件，每天调整控制者的攻击性。结果：24小时连续血糖监测平均值为157.414.4 mg/dL，其中63.6+/-9.2%的读数在70~180 mg/dL之间，2.9+/-2.3%的读数为250 mg/dL。中度高血糖相对常见，24.6+/-6.2%的读数在180至250 mg/dL之间，主要是在餐后3小时内。夜间平均CGM为139.6+/-27.6 mg/dL，其中70~180 mg/dL为77.9+/-16.4%，250 mg/dL为3.0+/-4.5%。餐后高血糖在未经宣布的膳食中比在已公布的膳食中更为常见(餐后4h CGM 197.8+/-44.1vs.140.6+/-35.0 mg/dL；P
Background: Initial Food and Drug Administration-approved artificial pancreas (AP) systems will be hybrid closed-loop systems that require prandial meal announcements and will not eliminate the burden of premeal insulin dosing. Multiple model probabilistic predictive control (MMPPC) is a fully closed-loop system that uses probabilistic estimation of meals to allow for automated meal detection. In this study, we describe the safety and performance of the MMPPC system with announced and unannounced meals in a supervised hotel setting. Research Design and Methods: The Android phone-based AP system with remote monitoring was tested for 72h in six adults and four adolescents across three clinical sites with daily exercise and meal challenges involving both three announced (manual bolus by patient) and six unannounced (no bolus by patient) meals. Safety criteria were predefined. Controller aggressiveness was adapted daily based on prior hypoglycemic events. Results: Mean 24-h continuous glucose monitor (CGM) was 157.414.4mg/dL, with 63.6 +/- 9.2% of readings between 70 and 180mg/dL, 2.9 +/- 2.3% of readings 250mg/dL. Moderate hyperglycemia was relatively common with 24.6 +/- 6.2% of readings between 180 and 250mg/dL, primarily within 3h after a meal. Overnight mean CGM was 139.6 +/- 27.6mg/dL, with 77.9 +/- 16.4% between 70 and 180mg/dL, 3.0 +/- 4.5% 250mg/dL. Postprandial hyperglycemia was more common for unannounced meals compared with announced meals (4-h postmeal CGM 197.8 +/- 44.1 vs. 140.6 +/- 35.0mg/dL; P