Continuous Subcutaneous Glucose Monitoring: A Descriptive Study of Its Use in Critical Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- To determine the cumulative incidence or risk of potential hypoglycemia during ICU admission
研究概览
简要总结
This is a single-center, observational, descriptive, longitudinal, and prospective study This study aims to determine the cumulative incidence during admission and the incidence rate of potential hypoglycemic events (defined as subcutaneous glucose <80 mg/dL detected by CGM) in patients admitted to the Intensive Care Unit (ICU) of HLA Moncloa Hospital over four years of follow-up. The study also aims to document the occurrences of hypoglycemic events, describe the characteristics of patients receiving CGM sensors, and outline the actions taken as a result of detecting potential hypoglycemic events
详细描述
The disturbances in glycemic control, including type 1 and type 2 diabetes, are increasingly prevalent in the general population, with estimates suggesting that this trend will continue for at least the next 20 years. Critically ill patients are particularly predisposed to glycemic alterations due, among other factors, to stress, fasting, infections, and administered treatments.
Hyperglycemia is detrimental to critically ill patients. Sustainedly elevated blood glucose levels lead to immunosuppression, hindering leukocyte function, reducing phagocytic capacity, and altering complement function. Furthermore, hyperglycemia enhances proinflammatory mechanisms and oxidative stress. Hemodynamic management is also affected, resulting in endothelial dysfunction and osmotic diuresis, promoting dehydration, electrolyte imbalances, and tissue hypoperfusion.
For this reason, most current recommendations for glycemic control in critically ill patients advise insulin treatment when blood glucose levels exceed 180 mg/dL. However, the ideal glucose range for maintaining patients is still a subject of debate because, despite knowing that hyperglycemia is harmful, its treatment carries a high risk of hypoglycemia. Severe hypoglycemia (glucose <40 mg/dL) increases the risk of death by more than three times in critically ill patients.
The incidence of hypoglycemia in critically ill patients varies widely depending on the type of patient and the protocol used for hyperglycemia control. Generally, it is estimated that between 3% and 20% of critically ill patients may experience severe hypoglycemia during their hospitalization. On the other hand, hypoglycemia can be easily prevented or treated in hospitalized patients through the infusion of glucose solutions if identified correctly.
In recent years, the use of continuous subcutaneous glucose monitoring (CGM) sensors has revolutionized clinical practice for non-hospitalized diabetic patients. Subcutaneous glucose is directly related to capillary blood glucose and arterial blood glucose, so changes in blood glucose concentration will be transmitted to subcutaneous tissue within the next 5 to 10 minutes. CGM in critically ill patients has been shown to significantly reduce the incidence of hypoglycemia, mortality, and glycemic variability compared to standard practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •The study will be conducted in patients admitted to the ICU of HLA Moncloa Hospital over four years. Patients admitted to the ICU, undergoing insulin treatment, and having a CGM sensor.
- •Patients who sign the voluntary consent to participate in the study (Annex 2). If the participant is not in full physical or intellectual capacity to provide their signature on the informed consent, the responsible investigator will request such consent from their direct family member or the person legally designated to make decisions on their behalf regarding health matters. This measure is taken to ensure that the participant's rights are respected, and the integrity of the consent process is maintained, even in situations where their decision-making capacity may be compromised.
排除标准
- •Patients from whom information on CGM cannot be obtained for technical reasons.
结局指标
主要结局
To determine the cumulative incidence or risk of potential hypoglycemia during ICU admission
时间窗: 4 years
To determine the cumulative incidence or risk of potential hypoglycemia during ICU admission (cases of potential hypoglycemia/number of patients x 100) and the incidence rate (cases of potential hypoglycemia/1000 x patient x hour) in critically ill patients undergoing insulin treatment using CGM sensors. The investigators will consider potential hypoglycemia any instance where the CGM sensor indicates low glucose (glucose \<80 mg/dL)
次要结局
- To determine the percentage of false potential hypoglycemia(4 years)
- To describe the glycemic profile of critically ill patients(4 years)
- To determine the incidence of severe hypoglycemia(4 years)
- To describe the type of patients admitted to the ICU who are equipped with a CGM sensor(4 years)
- To describe the actions taken by healthcare personnel after a potential hypoglycemia alarm(4 years)
- To describe the theoretical cumulative incidence of potential hypoglycemia with alternative thresholds of 70, 75, 85, or 90 mg/dL(4 years)
研究者
Samuel Gonzalez Lopez
Principal Investigator
Universidad Europea de Madrid