Insulin-Only STAR: Liège Clinical Trial Interim Results on Safety and Efficacy

Objective: Stress-induced hyperglycaemia and insulin resistance is common in critically ill patients and associated with worsened outcomes. STAR (Stochastic TARgeted) glycaemic control (GC) has proven effective over different units and clinical practices. However, this risk-based dosing approach uses both insulin and nutrition to control glycemia, where virtually all others use insulin only. This study uses STAR with insulin only and nutrition set clinically in the University Hospital of Liège, Belgium, to assess safety and efficacy in this use. Method: STAR-Liège is an insulin-only version of STAR targeting 80-145mg/dL. Patient are included if two successive BG measurements are >145mg/dL. Insulin is administered through IV catheter continuously and nutrition clinically set. GC was stopped after 72h or if BG was stable at insulin rate ≤2U/h. Safety is assessed by the %BG in severe (180mg/dL. Performance is evaluated by the %BG within target band and median BG. Clinical data from the first 11 patients is analysed, totalling 645 hours of control. Ethics approval was granted by the University Hospital of Liège Ethics Committee. Results: The insulin-only STAR-Liège protocol showed high performance, with median [IQR] BG of 122 [106, 147] mg/dL and 78% BG in target band. Mild hypoglycaemia occurred 1.6% of time, but there was no incidence of severe hypoglycaemia. Additionally, only 9.8% BG>180mg/dL, and administered insulin and nutrition was 4.0 [1.8, 4.6] U/h and 8.1 [4.9, 9.2] g/h. Conclusions: Insulin-only GC with the STAR-Liège protocol provided equally high control safety and quality for all patients. These results are encouraging, comparable to previous studies, and supporting STAR risk-based dosing approach as a robust solution across different ICU settings and usages, and support continuation of the clinical trial