Continuous Glucose Monitoring, Critical Care, Intensive Care, Critical Care Nursing, Critical Illness, Glucose Control, Hyperglycaemia
Conditions
Brief 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.
Interventions
DEVICEContinuous 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.
DEVICEConventional 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.
Sponsors
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants will be blinded. Both study groups will wear the same CGM sensor and receiver. In the experimental group, glucose data will be visible to the clinical team and used for glycaemic management. In the control group, continuous glucose monitoring data will be unavailable for clinical decision-making. Due to the nature of the intervention, ICU nurses and treating clinicians cannot be blinded to group assignment.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or over * Stay in ICU and/or intermediate care * Blood glucose levels \>180 mg/dL (10 mmol/L).
Exclusion criteria
* Pregnancy * Contraindications for the use of CGM (such as skin issues or allergies to adhesives) * End-of-life process
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range | During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal). | Percentage of time that glucose values remain within the target range of 70-180 mg/dL (3.9-10.0 mmol/L), measured by continuous glucose monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Above Range (TAR) | During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal). | Percentage of time that glucose values are above 180 mg/dL (10.0 mmol/L), measured by continuous glucose monitoring. |
| Time Below Range (TBR) | During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal). | Percentage of time that glucose values are below 70 mg/dL (3.9 mmol/L), measured by continuous glucose monitoring. |
| Number of Point-of-Care Glucose Measurements | During ICU stay (up ICU discharge or death) | Total number of point-of-care glucose measurements performed during ICU admission. |
| Hospital Readmissions | Up to 90 days after ICU discharge. | Number of participants readmitted to the hospital following discharge from the ICU. |
| Morbidity at 90 Days | Up to 90 days after ICU discharge. | Presence of illness, disease, or complications affecting health status, quality of life, or functional ability that occur during hospitalization or within 90 days following ICU discharge. |
| Mean Absolute Relative Difference (MARD) | During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal). | Accuracy of continuous glucose monitoring assessed by the Mean Absolute Relative Difference (MARD) between continuous glucose monitoring values and paired point-of-care glucose measurements. MARD will be calculated as the mean of the absolute relative differences between paired glucose values and expressed as a percentage. |
| Diabetes Technology Society (DTS) Error Grid Analysis | During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal). | Clinical risk associated with continuous glucose monitoring accuracy assessed using the Diabetes Technology Society (DTS) Error Grid. Paired continuous glucose monitoring and point-of-care glucose values will be classified according to risk categories, and the proportion of values within the no-risk and slight-risk zones will be reported. |
Countries
Spain
Contacts
STUDY_DIRECTOREva M Guix-Comellas, PhD
University of Barcelona
STUDY_DIRECTORAlberto Villamor-Ordozgoiti, PhD
Hospital Clínic of Barcelona
Outcome results
None listed