STAR-Liège Clinical Trial Interim Results: Safe and Effective Glycemic Control for All

Abstract

While the benefits of glycemic control for critically ill patients are increasingly demonstrated, the ability to deliver safe, effective control to intermediate target ranges is widely debated due to the increased risk of hypoglycemia. This study analyzes interim clinical trial results of the fully computerized model-based Stochastic TARgeted (STAR) glycemic control framework at the University Hospital of Liège, Belgium. Patients with dysglycemia were randomly assigned to the full version of STAR, modulating both insulin and nutrition inputs, or STAR-IO, an insulin only version of STAR. Both arms target the normoglycemic 80-145 mg/dL (4.4-8.0 mmol/L) band. Results are further compared to retrospective data from 20 patients under the standard unit protocol targeting a higher 100-150 mg/dL (5.6-8.3 mmol/L) band. Much higher time in target band is provided under the full version of STAR, with similar safety and significantly lower incidence of mild hyperglycemia (blood glucose > 145 mg/dL or 8.0 mmol/L) and severe hyperglycemia (blood glucose > 180 mg/dL or 10.0 mmol/L). As a result, lower median blood glucose levels are safely and consistently achieved with lower glycemic variability, suggesting STAR’s potential to improve clinical outcomes. These interim results show the possibility to achieve safe, effective control for all patients using STAR, and suggest glycemic control to lower targets could be beneficial.