Insulin Control Algorithm Validation Using Real CGM Action Differences

The patent creates virtual copies of patients (virtual patients) with simulated physiological models that replicate real patient behavior. These virtual patients are used to validate control algorithms through extensive simulations, eliminating the need for actual clinical trials while maintaining validation reliability. The virtual patients are generated from real patient data and can be extensively simulated without time or safety constraints.

The patent replaces the mechanical process of clinical trials with a computational simulation system. Instead of physically testing algorithms on real patients through clinical trials, the system uses computer-based virtual patients with physiological models to simulate and evaluate algorithm performance, thereby reducing validation time and eliminating safety risks associated with real-world testing.

The patent creates virtual copies of patients (virtual patients) with simulated physiological models that replicate real patient behavior. These virtual patients are used to validate control algorithms through extensive simulations, eliminating the need for actual clinical trials while maintaining validation reliability. The virtual patients are generated from real patient data and can be extensively simulated without time or safety constraints.

The patent introduces virtual patients as an intermediary between the control algorithm and real patients. The virtual patients serve as a safe intermediary medium that allows algorithm validation without directly exposing real patients to potential harm. The physiological models of virtual patients mediate the testing process, enabling safety evaluation while maintaining validation integrity.

The patent dynamically adjusts and refines the physiological model parameters of virtual patients based on real patient data. Instead of using fixed, biased simulator parameters, the system continuously updates model parameters to accurately reflect individual patient characteristics, thereby maintaining high simulation accuracy while benefiting from the time efficiency of virtual simulation.

The patent implements feedback mechanisms where simulation results are continuously compared with actual patient outcomes, and the virtual patient models are updated accordingly. This feedback loop ensures that the simulation accuracy is maintained at high levels by continuously refining the physiological models based on real-world performance data, eliminating the modeling biases inherent in static simulators.