Magni Lalo, Forgione Marco, Toffanin Chiara, Dalla Man Chiara, Kovatchev Boris, De Nicolao Giuseppe, Cobelli Claudio
Dipartimento di Informatica e Sistemistica, University of Pavia, Pavia, Italy.
J Diabetes Sci Technol. 2009 Sep 1;3(5):1091-8. doi: 10.1177/193229680900300512.
The technological advancements in subcutaneous continuous glucose monitoring and insulin pump delivery systems have paved the way to clinical testing of artificial pancreas devices. The experience derived by clinical trials poses technological challenges to the automatic control expert, the most notable being the large interpatient and intrapatient variability and the inherent uncertainty of patient information.
A new model predictive control (MPC) glucose control system is proposed. The starting point is an MPC algorithm applied in 20 type 1 diabetes mellitus (T1DM) subjects. Three main changes are introduced: individualization of the ARX model used for prediction; synthesis of the MPC law on top of the open-loop basal/bolus therapy; and a run-to-run approach for implementing day-by-day tuning of the algorithm. In order to individualize the ARX model, a sufficiently exciting insulin profile is imposed by splitting the premeal bolus into two smaller boluses (40% and 60%) injected 30 min before and 30 min after the meal.
The proposed algorithm was tested on 100 virtual subjects extracted from an in silico T1DM population. The trial simulates 44 consecutive days, during which the patient receives breakfast, lunch, and dinner each day. For 10 days, meals are multiplied by a random variable uniformly distributed in [0.5, 1.5], while insulin delivery is based on nominal meals. Moreover, for 10 days, either a linear increase or decrease of insulin sensitivity (+/-25% of nominal value) is introduced.
The ARX model identification procedure offers an automatic tool for patient model individualization. The run-to-run approach is an effective way to auto-tune the aggressiveness of the closed-loop control law, is robust to meal variation, and is also capable of adapting the regulator to slow parameter variations, e.g., on insulin sensitivity.
皮下连续血糖监测和胰岛素泵输送系统的技术进步为人工胰腺设备的临床试验铺平了道路。临床试验所积累的经验给自动控制专家带来了技术挑战,其中最显著的是患者间和患者内的巨大变异性以及患者信息的内在不确定性。
提出了一种新的模型预测控制(MPC)血糖控制系统。其出发点是应用于20名1型糖尿病(T1DM)受试者的MPC算法。引入了三个主要变化:用于预测的自回归外生(ARX)模型的个性化;在开环基础/大剂量疗法之上合成MPC法则;以及一种用于实现算法逐日调整的逐次运行方法。为了使ARX模型个性化,通过将餐前大剂量分为在餐前30分钟和餐后30分钟注射的两个较小剂量(40%和60%)来施加足够激励的胰岛素曲线。
所提出的算法在从计算机模拟的T1DM人群中提取的100个虚拟受试者上进行了测试。该试验模拟连续44天,在此期间患者每天接受早餐、午餐和晚餐。在10天内,餐量乘以在[0.5, 1.5]上均匀分布的随机变量,而胰岛素输送基于标称餐量。此外,在10天内,引入胰岛素敏感性的线性增加或降低(标称值的+/-25%)。
ARX模型识别程序为患者模型个性化提供了一种自动工具。逐次运行方法是自动调整闭环控制法则激进性的有效方法,对餐量变化具有鲁棒性,并且还能够使调节器适应缓慢的参数变化,例如胰岛素敏感性的变化。