Clinical trial protocol for continuous glucose monitoring in critical care at Hospital Clinic of Barcelona (CGM-UCI23)

Abstract

Background: Hyperglycaemia is common in intensive care units (ICUs), with a prevalence of up to 86.2%, increasing mortality. Technology has evolved towards continuous glucose monitoring (CGM), and its use in ICUs began especially during the coronavirus pandemic (COVID-19). Various studies have evaluated the reliability of CGM, indicating that it is safe for use in critically ill patients. Aim: The aim of this study was to compare the use of CGM with point-of-care glucose (POC-G) testing in ICU. Specific objectives include evaluating the glycaemic control, the frequency of POC-G measurements, the incidence of hyperglycaemia, hypoglycaemia and morbidity and mortality at 90 days. Study Design: An experimental, controlled and randomized clinical trial with a singleblind design will be conducted at Hospital Clinic of Barcelona (HCB). A sample size of 376 participants will be recruited and randomly assigned to two groups: an experimental group, where glycaemic management will be based on CGM; and a control group, where glucose will be managed through POC-G testing, with a blinded CGM. Results: The primary variable considered will be time in range (TIR), with secondary outcomes including, time above range (TAR), time below range (TBR), number of POC-G measurements, incidence of hyperglycaemia and hypoglycaemia, and mortality. Hypothesis testing will use the Kolmogorov–Smirnov test to assess data normality, with appropriate statistical tests applied, considering a p-value <.05. Relevance to Clinical Practice: The results obtained will help us understand the impact of CGM on critically ill patients. CGM could potentially reduce the workload of nurses and improve the efficiency of decision-making by the ICU team, enabling early identification and treatment of glucose complications, thereby enhancing safety. Patient safety, a reduction in patient fingerstick and a decreased care burden are the criteria that add value to this research.