In Silico Trials of an Open-Source Android-Based Artificial Pancreas: A New Paradigm to Test Safety and Efficacy of...

Safety data on Do-It-Yourself Artificial Pancreas Systems are missing. The most widespread in Europe is the AndroidAPS implementation of the OpenAPS algorithm. We used the UVA/Padova Type 1 Diabetes Simulator to in silico test safety and efficacy of this algorithm in different scenarios. We tested five configurations of the AndroidAPS algorithm differing in aggressiveness and patient's interaction with the system. All configurations were tested with insulin sensitivity variation of ±30%. The most promising configurations were tested in real-life scenarios: over- and underestimated bolus by 50%, bolus delivered 15 min before meal, and late bolus delivered 15 min after meal. Continuous Glucose Monitoring (CGM) time in ranges (TIRs) metrics were used to assess the glycemic control. In silico testing showed that open-source closed-loop system AndroidAPS works effectively and safely. The best results were reached if AndroidAPS algorithm worked with microboluses and when half of calculated bolus was issued (mean glycemia 131 mg/dL, SD 27 mg/dL, TIR 91%, time between 54 and 70 mg/dL <1%, and low blood glucose index even <1). The meal bolus over- and underestimation as well as late bolus did not affect the TIR and, importantly, the time between 54 and 70 mg/dL. In silico testing proved that AndroidAPS implementation of the OpenAPS algorithm is safe and effective, and it showed a great potential to be tested in prospective home setting study.