In-silico Risk Analysis of Personalized Artificial Pancreas Controllers via Rare-event Simulation
This work addresses the safety evaluation of medical devices for Type 1 diabetes patients, offering a more efficient way to estimate rare adverse events, though it is incremental as it builds on existing simulation and rare-event techniques.
The paper tackled the problem of assessing the safety of personalized artificial pancreas controllers for Type 1 diabetes by developing a simulation-based risk analysis tool, achieving a 72,000x speedup in simulation speed and up to 2-10 times increase in sampling adverse conditions compared to standard methods.
Modern treatments for Type 1 diabetes (T1D) use devices known as artificial pancreata (APs), which combine an insulin pump with a continuous glucose monitor (CGM) operating in a closed-loop manner to control blood glucose levels. In practice, poor performance of APs (frequent hyper- or hypoglycemic events) is common enough at a population level that many T1D patients modify the algorithms on existing AP systems with unregulated open-source software. Anecdotally, the patients in this group have shown superior outcomes compared with standard of care, yet we do not understand how safe any AP system is since adverse outcomes are rare. In this paper, we construct generative models of individual patients' physiological characteristics and eating behaviors. We then couple these models with a T1D simulator approved for pre-clinical trials by the FDA. Given the ability to simulate patient outcomes in-silico, we utilize techniques from rare-event simulation theory in order to efficiently quantify the performance of a device with respect to a particular patient. We show a 72,000$\times$ speedup in simulation speed over real-time and up to 2-10 times increase in the frequency which we are able to sample adverse conditions relative to standard Monte Carlo sampling. In practice our toolchain enables estimates of the likelihood of hypoglycemic events with approximately an order of magnitude fewer simulations.