Zisser Howard, Dassau Eyal, Lee Justin J, Harvey Rebecca A, Bevier Wendy, Doyle Francis J
Sansum Diabetes Research Institute, Santa Barbara, CA, USA Department of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA, USA
Sansum Diabetes Research Institute, Santa Barbara, CA, USA Department of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA, USA Institute for Collaborative Biotechnologies, University of California, Santa Barbara, Santa Barbara, CA, USA.
J Diabetes Sci Technol. 2015 May;9(3):564-72. doi: 10.1177/1932296815582061. Epub 2015 Apr 21.
The purpose of this study was to investigate whether or not adding a fixed preprandial dose of inhaled insulin to a fully automated closed loop artificial pancreas would improve the postprandial glucose control without adding an increased risk of hypoglycemia.
Nine subjects with T1DM were recruited for the study. The patients were on closed-loop control for 24 hours starting around 4:30 pm. Mixed meals (~50 g CHO) were given at 6:30 pm and 7:00 am the following day. For the treatment group each meal was preceded by the inhalation of one 10 U dose of Technosphere Insulin (TI). Subcutaneous insulin delivery was controlled by a zone model predictive control algorithm (zone-MPC). At 11:00 am, the patient exercised for 30 ± 5 minutes at 50% of predicted heart rate reserve.
The use of TI resulted in increasing the median percentage time in range (70-180 mg/dl, BG) during the 5-hour postprandial period by 21.6% (81.6% and 60% in the with/without TI cases, respectively, P = .06) and reducing the median postprandial glucose peak by 33 mg/dl (172 mg/dl and 205 mg/dl in the with and without TI cases, respectively, P = .004). The median percentage time in range 80-140 mg/dl during the entire study period was 67.5% as compared to percentage time in range without the use of TI of 55.2% (P = .03).
Adding preprandial TI (See video supplement) to an automated closed-loop AP system resulted in superior postprandial control as demonstrated by lower postprandial glucose exposure without addition hypoglycemia.
本研究旨在调查在全自动闭环人工胰腺中添加固定的餐前进食剂量吸入性胰岛素是否会在不增加低血糖风险的情况下改善餐后血糖控制。
招募了9名1型糖尿病受试者参与本研究。患者从下午4:30左右开始进行24小时闭环控制。在第二天下午6:30和上午7:00给予混合餐（约50克碳水化合物）。对于治疗组，每餐之前吸入一剂10单位的Technosphere胰岛素（TI）。皮下胰岛素输送由区域模型预测控制算法（区域-MPC）控制。上午11:00，患者以预测心率储备的50%进行30±5分钟的运动。
使用TI导致餐后5小时内血糖在目标范围内（70-180mg/dl，BG）的中位时间百分比增加21.6%（使用TI和未使用TI的情况下分别为81.6%和60%，P = 0.06），餐后血糖峰值中位数降低33mg/dl（使用TI和未使用TI的情况下分别为172mg/dl和205mg/dl，P = 0.004）。在整个研究期间，血糖在80-140mg/dl范围内的中位时间百分比为67.5%，而未使用TI时该范围的时间百分比为55.2%（P = 0.03）。
如视频补充所示，在自动闭环人工胰腺系统中添加餐前进食TI可实现更好的餐后控制，表现为餐后血糖暴露降低且无低血糖情况。
