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Clinical Trial Protocol for Continuous Glucose Monitoring in Critical Care
Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer
Summary
High blood glucose levels (hyperglycaemia) are very common in patients admitted to intensive care units (ICUs) and are associated with worse health outcomes. Traditionally, glucose levels in critically ill patients are monitored using point-of-care blood glucose (POC-G) testing (fingerstick, arterial, or venous blood samples), which may require multiple measurements each day. Continuous glucose monitoring (CGM) is a technology that measures glucose levels continuously throughout the day and night, providing real-time information and alerts when glucose levels are too high or too low. Previous studies have shown that CGM can be used safely in critically ill patients and may reduce the number of blood glucose tests required. However, more evidence is needed to determine whether CGM improves glucose control and patient outcomes in the ICU. The purpose of this study is to compare CGM-based glucose management with standard point-of-care glucose testing in critically ill patients with hyperglycaemia admitted to the Hospital Clínic of Barcelona. Participants will be randomly assigned to one of two groups. In the experimental group, healthcare professionals will use real-time CGM data to make glucose management decisions. In the control group, glucose management will be based on standard point-of-care testing, while CGM data will be collected in the background for later analysis. The study will evaluate whether CGM improves the amount of time that glucose levels remain within the target range, reduces episodes of high and low glucose, decreases the number of blood glucose tests required, and influences patient outcomes such as complications, hospital readmissions, and mortality up to 90 days after ICU discharge. Researchers hope that the results of this study will help determine whether CGM should become part of routine ICU care, improving patient safety, reducing the burden of glucose monitoring, and supporting more efficient clinical decision-making.
Official title: Continuous Glucose Monitoring in Critically Ill Patients: a Randomized Controlled Trial in the Intensive Care Units of Hospital Clínic of Barcelona (CGM-UCI23)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-06-14
Completion Date
2026-06-01
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
Continuous Glucose Monitoring
CGM uses a subcutaneous sensor inserted into the upper arm or abdomen to measure interstitial glucose every 5 minutes. The system provides real-time glucose values, trends, and configurable alerts for hyperglycaemia and hypoglycaemia to support glycaemic management. Point-of-care blood glucose measurements may be performed when clinically indicated for confirmation of hypoglycaemia, extreme glucose values, or according to institutional safety protocols during intravenous insulin therapy.
Conventional Glucose Measurement
Conventional glucose monitoring consists of capillary blood glucose measurements as the primary method for insulin dose adjustment according to standard ICU practice, complemented by arterial or venous blood glucose measurements when clinically indicated, all know as POC-G measurements. Glucose is typically measured approximately six times daily, with frequency adjusted according to clinical condition and insulin requirements. During the study, a CGM device is worn only for glucose data collection; CGM values remain blinded to healthcare professionals and are not used for clinical decision-making. All therapeutic decisions are based exclusively on conventional blood glucose measurements.
Locations (1)
Carrer de Villarroel, 170
Barcelona, Catalonia, Spain