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临床试验/NCT06400641
NCT06400641招募中不适用

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

Chinese Medical Association1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2023年2月1日最近更新:
适应症

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

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)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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