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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Continuous Glucose Monitoring

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 Type: Observational
• Enrollment (Estimated): 360

Contacts and Locations

• Study Contact: Name: Tao Gao, no; Phone Number: +86-025-83106666; Email: ggttt001@163.com
• Study Contact Backup: Name: Wenkui Yu, Professor

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Tao Gao, doctor; Phone Number: 86-025-83106666; Email: ggttt001@163.com
      • Contact: Email: taog1983@aliyun.com
      • Sub-Investigator: Tao Gao, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

critically ill patient

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese Medical Association
• Investigators: Principal Investigator: WenKui Yu, Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: insulin; blood glucose
• Other Study ID Numbers: ACCURATE study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No