Glucose evaluation and management in the ICU (GEM-ICU): Protocol for a bi-centre cohort study.

Introduction: Hyperglycaemia is common in intensive care unit (ICU) patients. Glycaemic monitoring and effective glycaemic control with insulin are crucial in the ICU to improve patient outcomes. However, glycaemic control and insulin use vary between ICU patients and hypo- and hyperglycaemia occurs. Therefore, we aim to provide contemporary data on glycaemic control and management, and associated outcomes, in adult ICU patients. We hypothesise that the occurrence of hypoglycaemia in acutely admitted ICU patients is lower than that of hyperglycaemia.

Methods: We will conduct a bi-centre cohort study of 300 acutely admitted adult ICU patients. Routine data will be collected retrospectively at baseline (ICU admission) and daily during ICU stay up to a maximum of 30 days. The primary outcome will be the number of patients with hypoglycaemia during their ICU stay. Secondary outcomes will be occurrence of severe hypoglycaemia, occurrence of hyperglycaemia, time below blood glucose target range, time above target range, all-cause mortality at Day 30, number of days alive without life support at Day 30 and number of days alive and out of hospital at Day 30. Process outcomes include the number of in-ICU days, glucose measurements (number of measurements and method) and use of insulin (including route of administration and dosage). All statistical analyses will be descriptive.

Conclusions: This cohort study will provide a contemporary overview of glucose evaluation and management practices in adult ICU patients and, thus, highlight potential areas for improvement through future clinical trials in this area.