Continuous Glucose Monitoring in Critically Ill Patients: a Randomized Controlled Trial in the Intensive Care Units of Hospital Clínic of Barcelona (CGM-UCI23)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Time in Range
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or over
- •Stay in ICU and/or intermediate care
- •Blood glucose levels >180 mg/dL (10 mmol/L).
排除标准
- •Pregnancy
- •Contraindications for the use of CGM (such as skin issues or allergies to adhesives)
- •End-of-life process
结局指标
主要结局
Time in Range
时间窗: 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.
次要结局
- Time Above Range (TAR)(During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).)
- Time Below Range (TBR)(During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).)
- Number of Point-of-Care Glucose Measurements(During ICU stay (up ICU discharge or death))
- Hospital Readmissions(Up to 90 days after ICU discharge.)
- Morbidity at 90 Days(Up to 90 days after ICU discharge.)
- Mean Absolute Relative Difference (MARD)(During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).)
- Diabetes Technology Society (DTS) Error Grid Analysis(During ICU stay (up to 10 days or until ICU discharge, death, or sensor removal).)
研究者
Marc Pañero Moreno
Principal Investigator
Institut d'Investigacions Biomèdiques August Pi i Sunyer