Doctorate in Health Sciences, Universidad Antonio Nariño, Bogotá, Colombia.
Mechanical, Electronics and Biomedical Engineering Faculty, Universidad Antonio Nariño, Bogotá, Colombia.
Int J Artif Organs. 2022 Jun;45(6):535-542. doi: 10.1177/03913988221095586.
Artificial pancreas systems usually define an insulin-on-board constraint () for safety schemes to limit the insulin infusion and avoid hypoglycemia during the closed-loop performance. Several methods have been proposed with impractical considerations requiring information from the prandial events or complex procedures for ambulatory use.
This paper presents a simple method that consists of two novel rules that allow finding an based only on common clinical parameters that do not require patient intervention. The method robustness was evaluated using a control system coupled to a safety layer under demanding scenarios implemented on the FDA-approved simulator for preclinical studies.
The method maintains a safe performance, even in the face of interpatient variability, hybrid and fully automatic implementations of an artificial pancreas system, and uncertain settings. Both proposed rules work as effectively or even better and without the patient intervention than other methods that have already been clinically validated.
This method can be used to define a constant that ensures performance and safety of the control system, even under scenarios with incorrect clinical data. Unlike other methods, this method only requires reliable information that is easily obtained from the patient, such as their total daily dose of insulin or body mass.
人工胰腺系统通常为安全方案定义一个可用胰岛素量（）限制，以限制闭环性能期间的胰岛素输注并避免低血糖。已经提出了几种方法，但由于需要来自进餐事件的信息或复杂的日常使用程序，因此具有不切实际的考虑因素。
本文提出了一种简单的方法，该方法由两个新规则组成，仅根据不需要患者干预的常见临床参数即可找到。该方法的鲁棒性使用耦合到安全层的控制系统进行了评估，该安全层在 FDA 批准的用于临床前研究的模拟器上实施了具有挑战性的场景。
该方法即使在面对患者间变异性、人工胰腺系统的混合和全自动实施以及不确定设置的情况下，仍能保持安全性能。所提出的两个规则的效果与已经临床验证的其他方法一样有效，甚至更好，而且无需患者干预。
该方法可用于定义一个常数，以确保控制系统的性能和安全性，即使在具有不正确临床数据的情况下也是如此。与其他方法不同，该方法仅需要从患者那里轻松获得的可靠信息，例如他们的胰岛素总日剂量或体重。
