Abstract
Background and Aims
Assessing algorithms of artificial pancreas systems is critical in developing automated and fault-tolerant solutions that work outside clinical settings. The development and evaluation of algorithms can be facilitated with a platform that conducts virtual clinical trials. We present a clinically validated cloud-based distributed platform that supports the development and comprehensive testing of single and dual-hormone algorithms for type 1 diabetes.
Methods
The platform is built on principles of object-oriented design, and runs user algorithms in real-time virtual clinical trials utilizing a multi-threaded environment enabled by concurrent execution over a cloud infrastructure. Users import a plugin into their algorithms (Matlab, Python, or Java) to connect to the platform. Once connected, users interact with a graphical interface to design experimental protocols for their trials. Protocols include trial duration in days, meal times and amounts, variability in meal times and amounts, carbohydrate counting errors, snacks, and onboard insulin levels. We validate and integrate into the platform a glucoregulatory system of ordinary differential equations (ODEs) parameterized with clinical data to mimic the inter and intra-day variability of glucose responses of 15 T1DM patients.
Results
The platform facilitates development by solving the ODE model in the cloud on large CPU-optimized machines, providing a 50% improvement in memory, speed and CPU utilization. Users can easily debug & modify code, test multiple strategies, and generate detailed clinical performance reports.
Conclusions
The platform utilizes the validated patient model to conduct virtual clinical trials for the rapid development and testing of closed-loop algorithms for T1DM.
