Clinical evaluation of an automated artificial pancreas using zone-model predictive control and health monitoring system

This study was performed to evaluate the safety and efficacy of a fully automated artificial pancreas using zone-model predictive control (zone-MPC) with the health monitoring system (HMS) during unannounced meals and overnight and exercise periods. A fully automated closed-loop artificial pancreas was evaluated in 12 subjects (eight women, four men) with type 1 diabetes (mean±SD age, 49.4±10.4 years; diabetes duration, 32.7±16.0 years; glycosylated hemoglobin, 7.3±1.2%). The zone-MPC controller used an a priori model that was initialized using the subject's total daily insulin. The controller was designed to keep glucose levels between 80 and 140 mg/dL. A hypoglycemia prediction algorithm, a module of the HMS, was used in conjunction with the zone controller to alert the user to consume carbohydrates if the glucose level was predicted to fall below 70 mg/dL in the next 15 min. The average time spent in the 70-180 mg/dL range, measured by the YSI glucose and lactate analyzer (Yellow Springs Instruments, Yellow Springs, OH), was 80% for the entire session, 92% overnight from 12 a.m. to 7 a.m., and 69% and 61% for the 5-h period after dinner and breakfast, respectively. The time spent < 60 mg/dL for the entire session by YSI was 0%, with no safety events. The HMS sent appropriate warnings to prevent hypoglycemia via short and multimedia message services, at an average of 3.8 treatments per subject. The combination of the zone-MPC controller and the HMS hypoglycemia prevention algorithm was able to safely regulate glucose in a tight range with no adverse events despite the challenges of unannounced meals and moderate exercise.