Study on the Feasibility of Continuous Glucose Monitoring(CGM) for Improving Blood Glucose Control in Severe Patients

Recruiting

• Conditions: Continuous Glucose Monitoring

• Registration Number: NCT06400641
• Lead Sponsor: Chinese Medical Association

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-02-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-05-03
• Last Update Submitted: 2024-05-03
• Study First Posted: 2024-05-06
• Last Update Posted: 2024-05-06
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Age≥ 18 years and < 80 years
• ICU stay ≤48 hours
• Expected ICU stay > 24 hours
• APACHE II score≥ 8

Exclusion Criteria

• local infection within the sensor placement area
• Laparotomy within lower abdomen
• Participated in this study before
• In other clinical trails.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CGM measurement	Days within the 1st week after ICU entrance	Test
60-day mortality rate	60 days after ICU entrance	Mortality
28-day mortality rate	28 days after ICU entrance	Mortality
Whole blood or fingertip blood glucose measurement	Days within the 1st week after ICU entrance	Test
ICU stay	During the ICU stay	Days
Mortality rate during ICU stay	Days from ICU entrance to ICU discharge	Mortality

Secondary Outcome Measures

Name	Time	Method
Serum C-peptide	Days within the 1st week after ICU entrance	Test
Thyroid hormones and other relevant hormone levels were measured	The 1st day and the 7th day after ICU entrance	Test
Insulin levels	Days within the 1st week after ICU entrance	Test

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China