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

NCT06400641 | Recruiting DMC

• 1 other identifier: ACCURATE study
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Continuous Glucose Monitoring

Keywords

blood glucose; insulin

Outcome Measures

Primary Outcomes (6)

• CGM measurement

  Test

  Days within the 1st week after ICU entrance

• Whole blood or fingertip blood glucose measurement

  Test

  Days within the 1st week after ICU entrance

• ICU stay

  Days

  During the ICU stay

• 28-day mortality rate

  Mortality

  28 days after ICU entrance

• 60-day mortality rate

  Mortality

  60 days after ICU entrance

• Mortality rate during ICU stay

  Mortality

  Days from ICU entrance to ICU discharge

Secondary Outcomes (3)

• Serum C-peptide

  Days within the 1st week after ICU entrance

• Insulin levels

  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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

critically ill patient

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese Medical Association: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Wenkui Yu, Professor

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Gao, no

CONTACT

+86-025-83106666; ggttt001@163.com

Wenkui Yu, Professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: May 6, 2024
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 6, 2024

Record last verified: 2024-02

Locations

CN (1)