Work

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

Year: 2024

Type: article

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 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. 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.

Source: Nursing in Critical Care

DOI: 10.1111/nicc.13198

Authors: Marc Pañero‐Moreno, Eva Maria Guix‐Comellas, Alberto Villamor‐Ordozgoiti

Institutions: Hospital Clínic de Barcelona, Consorci Institut D'Investigacions Biomediques August Pi I Sunyer, Universitat de Barcelona

Language: English

Topic: Hyperglycemia and glycemic control in critically ill and hospitalized patients

Subfield: Endocrinology, Diabetes and Metabolism

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $3,240