Comparison of Continuous Glucose Monitoring and Point-of-Care Measurements on the Intensive Care Unit: An Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Discrepancy glucose CGM - POC
研究概览
简要总结
Both hyperglycemia and hypoglycemia in patients at the intensive care unit (ICU) are strongly associated with increased morbidity and mortality. Accurate and timely measurements of glucose levels in this population are therefore crucial. Continuous glucose monitoring (CGM) appears promising for this purpose, but it is not yet used in the ICU due to insufficient knowledge about its reliability in critically ill patients. The aim of this study is to investigate the discrepancy between CGM and point-of-care measurements in ICU patients and whether this discrepancy is consistent across all ICU patient groups/characteristics.
This study investigates whether continuous glucose monitoring can be used in the intensive care setting.
详细描述
Hyperglycemia is present in up to 50% of patients admitted to an intensive care unit (ICU) and is strongly associated with elevated morbidity and mortality rates. Therefore, it is important to monitor glucose levels closely. In the ICU, glucose monitoring primarily relies on periodic measurements through point-of-care (POC) meters, which involve invasive blood sampling from venous or arterial lines. To maintain blood glucose concentrations within acceptable ranges, a possible improvement is continuous glucose monitoring (CGM), which is now used to manage glucose levels in diabetic patients in general settings and has shown significant benefits. Studies on the use of CGM in the ICU setting are limited. If CGM reliably measures glucose levels in critically ill patients, it enables earlier intervention and might help to predict hypo- or hyperglycemia based on measurement trends.
Objective
To investigate the discrepancy between CGM and POC measurements in insulin-dependent ICU patients and to study whether these potential discrepancies between CGM and POC vary across patient-related factors, like gender, age, comorbidities, medication use, disease severity scores, treatment in ICU.
Study design: Prospective, multi-centre, single-arm intervention, exploratory study
Intervention: All study participants receive one CGM sensor to monitor glucose levels. A second CGM sensor will only be applied if the first CGM sensor needed to be replaced within 8 days after insertion. The measurements will be blinded to all except the research team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients admitted to the ICU
- •Insulin-dependent as defined in local protocol
- •Age: ≥ 18 y
- •Expected length of stay in ICU more than 2 days
排除标准
- •Pregnancy
- •No informed consent
- •Therapeutic hypothermia (less than 34 degrees celsius)
- •Platelet count less than 50,000/μL at time of inclusion
- •Use of hydroxyurea
- •Use of acetaminophen more than 4 g/day
结局指标
主要结局
Discrepancy glucose CGM - POC
时间窗: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
Discrepancy between glucose levels (in mmol/L) measured with Continuous Glucose Monitoring (measured with the Dexcom G7 sensor) and Point-Of-Care (measured with the Accu-check) measurement in insulin-dependent Intensive Care Unit patients. The discrepancy is defined as the difference in absolute glucose levels in arterial blood samples.
Variation discrepancy across patient-related factors
时间窗: From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.
The variation of the potential difference in glucose levels (in mmol/L) between CGM (measured with the Dexcom G7 sensor) and POC (measured with the Accu-check) will be analyzed among the following patient-related factors: Age at the time of inclusion (in years). Body Mass Index (BMI) (in kg/m²). Gender (Male/Female). Comorbidities: Hypertension (Yes/No). Hypotension (Yes/No). Pre-existing diabetes (Yes/No). Edema (measured as weight gain in kg). Acidosis (pH value, continuous scale). Medication use: Corticosteroids (Yes/No). Inotropics (Yes/No and dosage in µg/kg/min). Vasopressors (Yes/No and dosage in µg/kg/min). APACHE II score (Scale). SOFA score (Scale). Reason for ICU admission (Categorical variable, e.g., sepsis, trauma, etc.). Length of ICU stay (in days). Duration of mechanical ventilation (in hours or days). Dialysis (Yes/No).
次要结局
- Adverse events(From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.)
- Number of missed hypo- and hypreglycemia episodes(From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.)
- Delay in detection hypo- or hyperglycemia episodes(From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.)
- Insertion CGM: time till reliable data and lasting time(From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.)
- Impact radiologic procedure(From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days, but only if a radiologic procedure is performed)
- Location GCM sensor(From enrollment until the completion of the continuous glucose monitoring (CGM) placement at 10 days.)
研究者
Kim Kamphorst
Principal Investigator
Deventer Ziekenhuis