The project investigates a formal verification framework for artificial pancreas (AP) controllers that automate the delivery of insulin to patients with type-1 diabetes (T1D). AP controllers are safety critical: excessive insulin delivery can lead to serious, potentially fatal, consequences. The verification framework under development allows designers of AP controllers to check that their control algorithms will operate safely and reliably against large disturbances that include patient meals, physical activities, and sensor anomalies including noise, delays, and sensor attenuation. The intellectual merits of the project lie in the development of state-of-the-art formal verification tools, that reason over mathematical models of the closed-loop including external disturbances and insulin-glucose response. These tools perform an exhaustive exploration of the closed loop system behaviors, generating potentially adverse situations for the control algorithm under verification. In addition, automatic techniques are being investigated to help AP designers improve the control algorithm by tuning controller parameters to eliminate harmful behaviors and optimize performance. The broader significance and importance of the project are to minimize the manual testing effort for AP controllers, integrate formal tools in the certification process, and ultimately ensure the availability of safe and reliable devices to patients with type-1 diabetes. The framework is made available to researchers who are developing AP controllers to help them verify and iteratively improve their designs. The team is integrating the research into the educational mission by designing hands-on courses to train undergraduate students in the science of Cyber-Physical Systems (CPS) using the design of AP controllers as a motivating example. Furthermore, educational material that explains the basic ideas, current challenges and promises of the AP concept is being made available to a wide audience that includes patients with T1D, their families, interested students, and researchers.
The research is being carried out collaboratively by teams of experts in formal verification for Cyber-Physical Systems, control system experts with experience designing AP controllers, mathematical modeling experts, and clinical experts who have clinically evaluated AP controllers. To enable the construction of the verification framework from the current state-of-the-art verification tools, the project is addressing major research challenges, including (a) building plausible mathematical models of disturbances from available clinical datasets characterizing human meals, activity patterns, and continuous glucose sensor anomalies. The resulting models are integrated in a formal verification framework; (b) simplifying existing models of insulin glucose response using smaller but more complex delay differential models; (c) automating the process of abstracting the controller implementation for the purposes of verification; (d) producing verification results that can be interpreted by control engineers and clinical researchers without necessarily understanding formal verification techniques; and (e) partially automating the process of design improvements to potentially eliminate severe faults and improve performance. The framework is evaluated on a set of promising AP controller designs that are currently under various stages of clinical evaluation.