Reddy Monika, Herrero Pau, El Sharkawy Mohamed, Pesl Peter, Jugnee Narvada, Thomson Hazel, Pavitt Darrell, Toumazou Christofer, Johnston Desmond, Georgiou Pantelis, Oliver Nick
1 Division of Diabetes, Endocrinology and Metabolism, Imperial College London , London, United Kingdom .
Diabetes Technol Ther. 2014 Sep;16(9):550-7. doi: 10.1089/dia.2014.0009. Epub 2014 May 6.
This study assesses proof of concept and safety of a novel bio-inspired artificial pancreas (BiAP) system in adults with type 1 diabetes during fasting, overnight, and postprandial conditions. In contrast to existing glucose controllers in artificial pancreas systems, the BiAP uses a control algorithm based on a mathematical model of β-cell physiology. The algorithm is implemented on a miniature silicon microchip within a portable hand-held device that interfaces the components of the artificial pancreas.
In this nonrandomized open-label study each subject attended for a 6-h fasting study followed by a 13-h overnight and post-breakfast study on a separate occasion. During both study sessions the BiAP system was used, and microboluses of insulin were recommended every 5 min by the control algorithm according to subcutaneous sensor glucose levels. The primary outcome was percentage time spent in the glucose target range (3.9-10.0 mmol/L).
Twenty subjects (55% male; mean [SD] age, 44 [10] years; duration of diabetes, 22 [12] years; glycosylated hemoglobin, 7.4% [0.7%] [57 (7) mmol/mol]; body mass index, 25 [4] kg/m(2)) participated in the fasting study, and the median (interquartile range) percentage time in target range was 98.0% (90.8-100.0%). Seventeen of these subjects then participated in the overnight/postprandial study, where 70.7% (63.9-77.4%) of time was spent in the target range and, reassuringly, 0.0% (0.0-2.3%) of time was spent in hypoglycemia (<3.9 mmol/L).
The BiAP achieves safe glycemic control during fasting, overnight, and postprandial conditions.
本研究评估一种新型生物启发式人工胰腺（BiAP）系统在1型糖尿病成年患者禁食、过夜及餐后状态下的概念验证和安全性。与人工胰腺系统中现有的葡萄糖控制器不同，BiAP使用基于β细胞生理学数学模型的控制算法。该算法在便携式手持设备内的微型硅微芯片上实现，该设备连接人工胰腺的各个组件。
在这项非随机开放标签研究中，每位受试者参加一次6小时的禁食研究，随后在另一个时间参加一次13小时的过夜及早餐后研究。在两个研究阶段均使用BiAP系统，控制算法根据皮下传感器葡萄糖水平每5分钟推荐一次胰岛素微剂量。主要结局是血糖目标范围内的时间百分比（3.9 - 10.0 mmol/L）。
20名受试者（55%为男性；平均[标准差]年龄，44[10]岁；糖尿病病程，22[12]年；糖化血红蛋白，7.4%[0.7%][57(7) mmol/mol]；体重指数，25[4] kg/m²）参加了禁食研究，目标范围内时间的中位数（四分位间距）百分比为98.0%（90.8 - 100.0%）。其中17名受试者随后参加了过夜/餐后研究，70.7%（63.9 - 77.4%）的时间处于目标范围内，且令人安心的是，低血糖（<3.9 mmol/L）时间占0.0%（0.0 - 2.3%）。
BiAP在禁食、过夜及餐后状态下实现了安全的血糖控制。
