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

NCT ID: NCT06400641

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-12-01

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.

Conditions

Continuous Glucose Monitoring

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Medical Association

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenkui Yu, Professor

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tao Gao, no

Role: CONTACT

ggttt001@163.com

+86-025-83106666

Wenkui Yu, Professor

Role: CONTACT

Facility Contacts

Tao Gao, doctor

Role: primary

ggttt001@163.com

86-025-83106666

Role: backup

taog1983@aliyun.com

Other Identifiers

ACCURATE study

Identifier Type: -

Identifier Source: org_study_id