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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06400641
Enrollment
360
Registered
2024-05-06
Start date
2023-02-01
Completion date
2024-12-01
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Continuous Glucose Monitoring

Keywords

blood glucose, insulin

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.

Interventions

None listed

Sponsors

Chinese Medical Association
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mortality rate during ICU stayDays from ICU entrance to ICU dischargeMortality
ICU stayDuring the ICU stayDays
28-day mortality rate28 days after ICU entranceMortality
60-day mortality rate60 days after ICU entranceMortality
CGM measurementDays within the 1st week after ICU entranceTest
Whole blood or fingertip blood glucose measurementDays within the 1st week after ICU entranceTest

Secondary

MeasureTime frameDescription
Insulin levelsDays within the 1st week after ICU entranceTest
Thyroid hormones and other relevant hormone levels were measuredThe 1st day and the 7th day after ICU entranceTest
Serum C-peptideDays within the 1st week after ICU entranceTest

Countries

China

Contacts

Primary ContactTao Gao, no
ggttt001@163.com+86-025-83106666
Backup ContactWenkui Yu, Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026