System for monitoring and delivering medication to a patient and method of using the same to minimize the risks associated with automated therapy

A system for determining whether it is safe to operate a closed loop delivery of insulin to a patient, the system comprising:

• a controller;
• and a sensor in communication with the controller, said sensor configured to measure an indication of glucose in the patient;
• wherein the controller is configured to:
• provide a risk profile to a clinician for the patient, wherein the risk profile comprises a matrix including a plurality of risk levels for varying values of glucose, change in glucose, and change in insulin;
• receive an input from the clinician for each of the plurality of risk levels;
• receive measurements indicative of glucose in the patient from the sensor;
• determine a first trend corresponding to a change in insulin for the patient;
• determine a second trend corresponding to a change in the glucose measurements;
• apply rules on the received measurements, the first trend, and the second trend, wherein the rules include the risk profile that was parameterized by the clinician for when to exit closed loop delivery for the patient;
• determine whether it is safe to operate a closed loop delivery of insulin to the patient based on the application of rules;
• and prevent exit closed loop delivery of insulin and prompt user intervention based on the determination of safety using the application of rules.