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Continuous Glucose MonitoringNCT06400641

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

An observational study of Continuous Glucose Monitoring, run by Chinese Medical Association at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Continuous Glucose Monitoring
How many people
360 participants
Where
1 siteChina
Study dates
1 Feb 2023to 1 Dec 2024
How long will I take part?
2 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: critically ill patient

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Tao Gao, no contact

+86-025-83106666

ggttt001@163.com

Wenkui Yu, Professor contact

China1 site, 1 recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210000

    Tao Gao, doctor, 86-025-83106666, ggttt001@163.com

    taog1983@aliyun.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Keywords
blood glucose, insulin
Medical subject headings
Insulin Resistance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CGM measurement

    Test

    Measured: Days within the 1st week after ICU entrance

  2. Whole blood or fingertip blood glucose measurement

    Test

    Measured: Days within the 1st week after ICU entrance

  3. ICU stay

    Days

    Measured: During the ICU stay

  4. 28-day mortality rate

    Mortality

    Measured: 28 days after ICU entrance

  5. 60-day mortality rate

    Mortality

    Measured: 60 days after ICU entrance

  6. Mortality rate during ICU stay

    Mortality

    Measured: Days from ICU entrance to ICU discharge

Secondary outcomes (3)

  1. Serum C-peptide

    Test

    Measured: Days within the 1st week after ICU entrance

  2. Insulin levels

    Test

    Measured: Days within the 1st week after ICU entrance

  3. Thyroid hormones and other relevant hormone levels were measured

    Test

    Measured: The 1st day and the 7th day after ICU entrance

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2024
  2. Study start1 Feb 2023
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
360 participants (estimated)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06400641
Sponsor's protocol ID
ACCURATE study
Status last verified
Feb 2024
First submitted
20 Feb 2024
Last updated
6 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Continuous Glucose Monitoring, run by Chinese Medical Association at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tao Gao, no (+86-025-83106666, ggttt001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CGM measurement (time frame: Days within the 1st week after ICU entrance). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06400641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.

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