A Review of Safety and Hazards Associated With the Artificial Pancreas

The artificial pancreas (AP) is a closed-loop device with the potential to reduce the complications associated with type 1 diabetes mellitus by maintaining euglycemia in patients. The AP encompasses an algorithm that determines the amount of insulin (and other hormones) to be administered to the patient via a continuous subcutaneous insulin infusion pump using information provided by a continuous glucose monitor and other sensors. As the AP approaches commercialization, special attention must be given to safety within all the individual components, including physiological changes in the patient, as well as safety issues that can arise when these components are combined into a single system. Therefore, we analyzed the specific hazards applicable to the AP with the aim of exposing areas of safety that are yet to be addressed.