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lüll In silico preclinical trials: methodology and engineering guide to closed-loop control in type 1 diabetes mellitus Patek SD; Bequette BW; Breton M; Buckingham BA; Dassau E; Doyle FJ 3rd; Lum J; Magni L; Zisser HJ Diabetes Sci Technol 2009[Mar]; 3 (2): 269-82This 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.|*Algorithms[MESH]|*Computer Simulation[MESH]|*Pancreas, Artificial[MESH]|Blood Glucose/*physiology[MESH]|Diabetes Mellitus, Type 1/blood/*therapy[MESH]|Food[MESH]|Humans[MESH]|Insulin Infusion Systems[MESH]|Insulin/physiology[MESH] |