CGM for Improving Blood Glucose Control in Severe Patients and the Feasibility of Automatic Drug Delivery in Combination With Insulin Pumps: A Prospective Multi-center Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- 28-day mortality rate
研究概览
简要总结
Compared to traditional blood glucose monitoring (TGM), CGM can accurately capture asymptomatic hyperglycemia and hypoglycemia events that are missed by TGM, accounting for 33% and 90% of cases, respectively. Real-time CGM provides instantaneous glucose levels and can also generate alarms for hypoglycemia and hyperglycemia based on preset glucose ranges, assisting patients in making timely adjustments to their glucose levels. Clinical studies have found that glucose control guided by real-time CGM is better, and the decrease in glycosylated hemoglobin levels is positively correlated with the frequency of CGM use. More importantly, although glucose variability can be calculated using conventional blood glucose measurements taken every four to six hours, to further assess precise changes in glucose levels, more detailed and accurate continuous data are required. In this respect, CGM has unparalleled advantages over traditional blood glucose monitoring.While the use of CGM in critically ill patients is still controversial.
详细描述
We conducted this clinical study to compare the effectiveness of CGM and traditional blood glucose monitoring in guiding blood glucose control in critically ill patients, and to clarify the feasibility of using CGM for critically ill patients. We also aimed to explore the possible factors that affect CGM in critically ill patients.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥ 18 years and < 80 years
- •ICU stay ≤48 hours
- •Expected ICU stay > 24 hours
- •APACHE II score≥ 8
排除标准
- •local infection within the sensor placement area
- •Laparotomy within lower abdomen
- •Participated in this study before
- •In other clinical trails.
结局指标
主要结局
28-day mortality rate
时间窗: 28 days after ICU entrance
Mortality
Whole blood or fingertip blood glucose measurement
时间窗: Days within the 1st week after ICU entrance
Test
ICU stay
时间窗: During the ICU stay
Days
CGM measurement
时间窗: Days within the 1st week after ICU entrance
Test
Mortality rate during ICU stay
时间窗: Days from ICU entrance to ICU discharge
Mortality
60-day mortality rate
时间窗: 60 days after ICU entrance
Mortality
次要结局
- Serum C-peptide(Days within the 1st week after ICU entrance)
- Thyroid hormones and other relevant hormone levels were measured(The 1st day and the 7th day after ICU entrance)
- Insulin levels(Days within the 1st week after ICU entrance)
