Evaluation of an Artificial Pancreas with Enhanced Model Predictive Control and a Glucose Prediction Trust Index with Unannounced Exercise

We investigated the safety and efficacy of the addition of a trust index to enhanced Model Predictive Control (eMPC) Artificial Pancreas (AP) that works by adjusting the responsiveness of the controller's insulin delivery based on the confidence intervals around predictions of glucose trends. This constitutes a dynamic adaptation of the controller's parameters in contrast with the widespread AP implementation of individualized fixed controller tuning. After 1 week of sensor-augmented pump (SAP) use, subjects completed a 48-h AP admission that included three meals/day (carbohydrate range 29-57 g/meal), a 1-h unannounced brisk walk, and two overnight periods. Endpoints included sensor glucose percentage time 70-180, 180 mg/dL, number of hypoglycemic events, and assessment of the trust index versus standard eMPC glucose predictions. Baseline characteristics for the 15 subjects who completed the study (mean ± SD) were age 46.1 ± 17.8 years, HbA1c 7.2% ± 1.0%, diabetes duration 26.8 ± 17.6 years, and total daily dose (TDD) 35.5 ± 16.4 U/day. Mean sensor glucose percent time 70-180 mg/dL (88.0% ± 8.0% vs. 74.6% ± 9.4%),