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

Abstract

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. 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. An experimental, controlled and randomized clinical trial with a single-blind 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. 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. 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.