Constraints on the insulin infusion for artificial pancreas clinical trials

Artificial Pancreas (AP) systems for people with type 1 diabetes combine the use of a smart insulin pump with a Continuous Glucose Monitor (CGM) and a control algorithm to improve the regulation of the insulin delivery during the postprandial period. New control algorithms need to be tested in clinical trials. In this paper, a safety layer called the SAFE loop [1] is reformulated to be employed during clinical trials using a time-varying constraint on the IOB, which diminishes the risk of an hypoglycemic event when testing fully closed-loop algorithms. The proposed operation mode is evaluated in silico and the results contrasted with the ones obtained without IOB limitation.