The Accuracy, Feasibility, Safety and Confounding Factors of Real-time Continuous Glucose Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The International Standardization Organization (ISO) criteria
研究概览
简要总结
Real-time continuous glucose monitoring system (CGMS) has been attempted to be used in ICU, but its feasibility, accuracy and confounding factors are controversial.
详细描述
Acute glucose metabolic disorder (hyperglycemia, hypoglycemia and high glucose variability) is common during critical illness and associated with poor prognosis.Continuous glucose monitoring system (CGMS), which providing continuous glucose values, is promising to overcome these problems mentioned above and finally optimize glucose control.But its feasibility, accuracy and confounding factors are controversial.The aims of this study is to assess the accuracy, feasibility and safety of CGMS in daily routine in a general ICU in comparison with simultaneous laboratory arterial blood glucose (ABG) values
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Inclusion criteria: Critically ill patients who were older than 18 years old and expected length of ICU stay longer than 48 hours
排除标准
- •they were pregnant.2) had broken skin. 3) had a platelet count of less than 30 × 109/L 4) had participated in another trial.5) diabetic ketoacidosis or hyperosmotic coma.6) judged to be improper to complete this trial by the investigator
结局指标
主要结局
The International Standardization Organization (ISO) criteria
时间窗: CGMS will be used up to 5 days
more than 95% of CGMS readings should be within 0.83mmol/L( of the reference values when the reference value is ≤5.56mmol/L and within 15.0% of the reference values when the reference value is \>5.56mmol/L
Mean absolute relative difference(MARD) and possible confounding factors
时间窗: CGMS will be used up to 5 days
The MARD in critical ill patients should not be more than 14%.Stratified MARD according to 7 factors(history of diabetes, blood glucose variability （determined using standard deviation of blood glucose）, glucose ranges(\<4.4mmol/L,4.4-10mmol/L,\>10mmol/L）, vasoactive drugs,continuous renal replacement therapy(CRRT), glucocorticoids, enteral nutrition(EN) and parenteral nutrition(PN) will be calculated and made a comparison.
Clarke error grid analysis
时间窗: CGMS will be used up to 5 days
More than 98% data pairs should locate in "accuracy zone(Zone A)" and "clinically acceptable zone(Zone B)"
Surveillance error grid
时间窗: CGMS will be used up to 5 days
There is no definite data field.The results will be analyzed comprehensively
The Spearman correlation analysis
时间窗: CGMS will be used up to 5 days
correlation coefficient (between 0.3 and 0.5):low correlation;(between 0.5 and 0.8);moderate correlation;(above 0.8):high correlation
Bland-altman analysis
时间窗: CGMS will be used up to 5 days
more than 95% CGMS-arterial blood glucose(ABG) data pairs should be within the agreement range.
次要结局
未报告次要终点