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

Continuous Glucose Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400641
• Other study ID #: ACCURATE study
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Chinese Medical Association
• Contact: Tao Gao, no
• Phone: +86-025-83106666
• Email: ggttt001[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Continuous Glucose Monitoring

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Medical Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGM measurement	Test	Days within the 1st week after ICU entrance
Primary	Whole blood or fingertip blood glucose measurement	Test	Days within the 1st week after ICU entrance
Primary	ICU stay	Days	During the ICU stay
Primary	28-day mortality rate	Mortality	28 days after ICU entrance
Primary	60-day mortality rate	Mortality	60 days after ICU entrance
Primary	Mortality rate during ICU stay	Mortality	Days from ICU entrance to ICU discharge
Secondary	Serum C-peptide	Test	Days within the 1st week after ICU entrance
Secondary	Insulin levels	Test	Days within the 1st week after ICU entrance
Secondary	Thyroid hormones and other relevant hormone levels were measured	Test	The 1st day and the 7th day after ICU entrance