Wilson Leah M, Jacobs Peter G, Ramsey Katrina L, Resalat Navid, Reddy Ravi, Branigan Deborah, Leitschuh Joseph, Gabo Virginia, Guillot Florian, Senf Brian, El Youssef Joseph, Steineck Isabelle Isa Kristin, Tyler Nichole S, Castle Jessica R
Harold Schnitzer Diabetes Health Center, Division of Endocrinology, Oregon Health & Science University, Portland, OR
Artificial Intelligence for Medical Systems (AIMS) Lab, Department of Biomedical Engineering, Oregon Health & Science University, Portland, OR.
Diabetes Care. 2020 Nov;43(11):2721-2729. doi: 10.2337/dc19-2267. Epub 2020 Sep 9.
To assess the efficacy and feasibility of a dual-hormone (DH) closed-loop system with insulin and a novel liquid stable glucagon formulation compared with an insulin-only closed-loop system and a predictive low glucose suspend (PLGS) system.
In a 76-h, randomized, crossover, outpatient study, 23 participants with type 1 diabetes used three modes of the Oregon Artificial Pancreas system: ) dual-hormone (DH) closed-loop control, ) insulin-only single-hormone (SH) closed-loop control, and ) PLGS system. The primary end point was percentage time in hypoglycemia (<70 mg/dL) from the start of in-clinic aerobic exercise (45 min at 60% VO) to 4 h after.
DH reduced hypoglycemia compared with SH during and after exercise (DH 0.0% [interquartile range 0.0-4.2], SH 8.3% [0.0-12.5], = 0.025). There was an increased time in hyperglycemia (>180 mg/dL) during and after exercise for DH versus SH (20.8% DH vs. 6.3% SH, = 0.038). Mean glucose during the entire study duration was DH, 159.2; SH, 151.6; and PLGS, 163.6 mg/dL. Across the entire study duration, DH resulted in 7.5% more time in target range (70-180 mg/dL) compared with the PLGS system (71.0% vs. 63.4%, = 0.044). For the entire study duration, DH had 28.2% time in hyperglycemia vs. 25.1% for SH ( = 0.044) and 34.7% for PLGS ( = 0.140). Four participants experienced nausea related to glucagon, leading three to withdraw from the study.
The glucagon formulation demonstrated feasibility in a closed-loop system. The DH system reduced hypoglycemia during and after exercise, with some increase in hyperglycemia.
评估一种含胰岛素和新型液体稳定胰高血糖素制剂的双激素（DH）闭环系统与仅含胰岛素的闭环系统及预测性低血糖暂停（PLGS）系统相比的疗效和可行性。
在一项为期76小时的随机、交叉、门诊研究中，23名1型糖尿病患者使用了俄勒冈人工胰腺系统的三种模式：）双激素（DH）闭环控制，）仅含胰岛素的单激素（SH）闭环控制，以及）PLGS系统。主要终点是从临床有氧运动开始（60%VO₂下45分钟）至之后4小时低血糖（<70mg/dL）的时间百分比。
与SH相比，运动期间及运动后DH降低了低血糖发生率（DH为0.0%[四分位间距0.0 - 4.2]，SH为8.3%[0.0 - 12.5]，P = 0.025）。与SH相比，运动期间及运动后DH的高血糖（>180mg/dL）时间增加（DH为20.8%，SH为6.3%，P = 0.038）。整个研究期间的平均血糖水平为：DH为159.2mg/dL，SH为151.6mg/dL，PLGS为163.6mg/dL。在整个研究期间，与PLGS系统相比，DH处于目标范围（70 - 180mg/dL）的时间多7.5%（71.0%对63.4%，P = 0.044）。在整个研究期间，DH有28.2%的时间处于高血糖状态，SH为25.1%（P = 0.044），PLGS为34.7%（P = 0.140）。4名参与者出现与胰高血糖素相关的恶心，导致3人退出研究。
胰高血糖素制剂在闭环系统中显示出可行性。DH系统降低了运动期间及运动后的低血糖发生率，但高血糖情况有所增加。
