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In silico preclinical trials: methodology and engineering guide to closed-loop control in type 1 diabetes mellitus.
In silico preclinical trials: methodology and engineering guide to closed-loop control in type 1 diabetes mellitus. Journal of diabetes science and technology Patek, S. D., Bequette, B. W., Breton, M., Buckingham, B. A., Dassau, E., Doyle, F. J., Lum, J., Magni, L., Zisser, H. 2009; 3 (2): 269-282Abstract
This article sets forth guidelines for in silico (simulation-based) proof-of-concept testing of artificial pancreas control algorithms. The goal was to design a test procedure that can facilitate regulatory approval [e.g., Food and Drug Administration Investigational Device Exemption] for General Clinical Research Center experiments without preliminary testing on animals. The methodology is designed around a software package, based on a recent meal simulation model of the glucose-insulin system. Putting a premium on generality, this document starts by specifying a generic, rather abstract, meta-algorithm for control. The meta-algorithm has two main components: (1) patient assessment and tuning of control parameters, i.e., algorithmic processes for collection and processing patient data prior to closed-loop operation, and (2) controller warm-up and run-time operation, i.e., algorithmic processes for initializing controller states and managing blood glucose. The simulation-based testing methodology is designed to reveal the conceptual/mathematical operation of both main components, as applied to a large population of in silico patients with type 1 diabetes mellitus.
View details for PubMedID 20144358
View details for PubMedCentralID PMC2771529