Diabetes is a heterogeneous group of diseases that share a common trait of elevated blood glucose levels. Insulin lowers this level by promoting glucose utilization, thus avoiding short- and long-term organ damage due to the elevated blood glucose level. A patient with diabetes uses an insulin pump to dose insulin. The pump uses a controller to compute and dose the correct amount of insulin to keep blood glucose levels in a safe range. Insulin-pump controller development is an ongoing process aiming at fully closed-loop control. Controllers entering the market must be evaluated for safety. We propose an evaluation method that exploits an FDA-approved diabetic patient simulator. The method evaluates a Cartesian product of individual insulin-pump parameters with a fine degree of granularity. As this is a computationally intensive task, the simulator executes on a distributed cluster. We identify safe and risky combinations of insulin-pump parameter settings by applying the binomial model and decision tree to this product. As a result, we obtain a tool for insulin-pump settings and controller safety assessment. In this paper, we demonstrate the tool with the Low-Glucose Suspend and OpenAPS controllers. For average ± standard deviation, LGS and OpenAPS exhibited 1.7 ± 0.6% and 3.2 ± 1.8% of local extrema (i.e., good insulin-pump settings) out of all the entire Cartesian products, respectively. A continuous region around the best-discovered settings (i.e., the global extremum) of the insulin-pump settings spread across 4.0 ± 1.1% and 4.1 ± 1.3% of the Cartesian products, respectively.

Department of Computer Science and Engineering New Technologies for Information Society University of West Bohemia Technicka 18 330 01 Pilsen Czech Republic

Department of Computer Science and Engineering University of West Bohemia Technicka 18 330 01 Pilsen Czech Republic

ICAR National Research Council of Italy Via P Castellino 80131 Naples Italy

Natural Computation Lab Department of Information Engineering Electrical Engineering and Applied Mathematics University of Salerno Via Giovanni Paolo 2 132 84084 Fisciano Italy

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