Validation of a Model-based Virtual Trials Method for Tight Glycemic Control in Intensive Care

Abstract

In-silico virtual trials offer significant advantages in cost, time and safety. However, no such method has been truly validated with clinical data. This study tests 2 matched cohorts from an independent ICU treated with 2 different glycaemic control protocols. The goal is to validate the in-silico virtual trials model and methods, including the underlying assumptions. A retrospective analysis used records from a 211 patient subset of the Glucontrol trial in Liege, Belgium. Glucontrol-A (N = 142) targeted a BG range of 4.4-6.1 mmol/L and Glucontrol-B (N = 69) targeted 7.8-10.0 mmol/L. Cohorts were matched by APACHE II score, but the Glucontrol A cohort was slightly older (p = 0.0352). Results showed high correlation between self- and cross-validation virtual trials and clinical results. The virtual trials models and methods are thus validated on independent data.