Clinical trial NCT06400641: Study on the Feasibility of Continuous Glucose Monitoring(CGM) for Improving Blood Glucose Control in Severe Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Continuous Glucose Monitoring
Keywords: blood glucose
insulin
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2024-05-06
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: critically ill patient

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.

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.

Primary outcomes:
measure: CGM measurement
timeFrame: Days within the 1st week after ICU entrance
measure: Whole blood or fingertip blood glucose measurement
timeFrame: Days within the 1st week after ICU entrance
measure: ICU stay
timeFrame: During the ICU stay
measure: 28-day mortality rate
timeFrame: 28 days after ICU entrance
measure: 60-day mortality rate
timeFrame: 60 days after ICU entrance
measure: Mortality rate during ICU stay
timeFrame: Days from ICU entrance to ICU discharge
Secondary outcomes:
measure: Serum C-peptide
timeFrame: Days within the 1st week after ICU entrance
measure: Insulin levels
timeFrame: Days within the 1st week after ICU entrance
measure: Thyroid hormones and other relevant hormone levels were measured
timeFrame: The 1st day and the 7th day after ICU entrance
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Wenkui Yu, Professor
role: PRINCIPAL_INVESTIGATOR
References: