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Cardiac DiseaseNCT06275971

Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients

A study testing Dexcom G6 and SMBG or venous/arterial blood glucose in people with Cardiac Disease and PreDiabetes, run by Kangbuk Samsung Hospital at 1 site in South Korea.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The aim of this study is to assess the level of glycemic control and the incidence of surgery-related complications in cardiac patients post-surgery when Continuous Glucose Monitoring (CGM) is utilized, as compared to traditional methods of arterial/venous blood sampling and Point-of-Care Testing (POCT) for glucose… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Disease, PreDiabetes, Diabetes Mellitus
What is being tested?
Dexcom G6 and SMBG or venous/arterial blood glucose
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteSouth Korea
Study dates
24 Nov 2022to 31 Aug 2024
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects waiting for Elective Cardiac Surgery (CABG, Cardiac Valve Operation, Congenital heart anomaly surgery, aortic surgery, etc.)
  • Subjects over the age of 18
  • Patients with type 2 diabetes
  • Patients with prediabetes
  • HbA1c 5.7% or more
  • fasting blood glucose 100 mg/dL or more
  • 2 hours 75g-OGTT 140 mg/dL or more

Who cannot join

  • Emergency surgery patients
  • Patients performing co-operation other than cardiac surgery
  • Patients with type 1 diabetes
  • Total Pancreatectomy patients
  • Patients with high surgical severity (STS score of 8 or more or EURO score of 5 or more)
  • Patients who do not consent to the study
Show all 11Show fewer
  • Severe patients who are deemed difficult to continue research during surgery (excluded at the researcher's discretion)
  • Cases where severe weight gain and severe edema occur after surgery
  • Cases where the surgery time is significantly longer than average
  • Cases where cardiopulmonary bypass is used more than once during surgery
  • Others who are deemed unsuitable for research progression at the researcher's discretion

Trial locations and contacts

1 site in 1 country.

Cheol-Young Park, MD, PhD contact

+82220011550

cydoctor68@gmail.com

Sun Joon Moon, MD contact

+82220011550

ipleat.m@gmail.com

South Korea1 site, 1 recruiting

  • Kangbuk Samsung Hospital

    Seoul, 03181

    Sun Joon Moon, MD

    Recruiting

Other trials in South Korea

About this study

The aim of this study is to assess the level of glycemic control and the incidence of surgery-related complications in cardiac patients post-surgery when Continuous Glucose Monitoring (CGM) is utilized, as compared to traditional methods of arterial/venous blood sampling and Point-of-Care Testing (POCT) for glucose monitoring.

Being tested
Dexcom G6, SMBG or venous/arterial blood glucose
Keywords
continuous glucose monitoring
Medical subject headings
Heart Diseases, Prediabetic State, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexcom G6Device

    Glycemic control was monitored using CGM data for seven days following cardiac surgery

  • SMBG or venous/arterial blood glucoseDevice

    Glycemic control was monitored using SMBG or venous/arterial blood glucose data for seven days following cardiac surgery

Study groups in NCT06275971
Study groupRoleWhat they receive
CGM armExperimentalGlycemic control was monitored using CGM data for seven days following cardiac surgery
Receives: Device: Dexcom G6
SMBG or venous/arterial glucose armActive comparatorGlycemic control was monitored using SMBG or venous/arterial glucose data for seven days following cardiac surgery
Receives: Device: SMBG or venous/arterial blood glucose

What is being measured

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

  1. Time within the target range of 100-180 mg/dL

    Time within the target range of 100-180 mg/dL as assessed by CGM for 7 days after surgery

    Measured: 1-7 days after surgery

Secondary outcomes (19)

  1. Time within the target range of 100-140 mg/dL

    Time within the target range of 100-140 mg/dL as assessed by CGM for 7 days after surgery

    Measured: 1-7 days after surgery

  2. Time within the target range of 70-180 mg/dL

    Time within the target range of 70-180 mg/dL as assessed by CGM for 7 days after surgery

    Measured: 1-7 days after surgery

  3. Time to reach <70 mg/dL

    Time to reach <70 mg/dL as assessed by CGM for 7 days after surgery

    Measured: 1-7 days after surgery

  4. Time to reach <54 mg/dL

    Time to reach <54 mg/dL as assessed by CGM for 7 days after surgery

    Measured: 1-7 days after surgery

  5. Time to reach >180 mg/dL

    Time to reach >180 mg/dL as assessed by CGM for 7 days after surgery

    Measured: 1-7 days after surgery

  6. Time to reach >250 mg/dL

    Time to reach >250 mg/dL as assessed by CGM for 7 days after surgery

    Measured: 1-7 days after surgery

  7. Standard Deviation (SD)

    SD value evaluated by CGM for 7 days after surgery

    Measured: 1-7 days after surgery

  8. Coefficient of variation (CV)

    CV value evaluated by CGM for 7 days after surgery

    Measured: 1-7 days after surgery

  9. Mean glucose

    Mean glucose value evaluated by CGM for 7 days after surgery

    Measured: 1-7 days after surgery

  10. Glucose management indicator (GMI)

    GMI value evaluated by CGM for 7 days after surgery

    Measured: 1-7 days after surgery

  11. Number of days of ICU hospitalization

    Number of days of ICU hospitalization

    Measured: From 1 day after surgery until the date of ICU discharge or date of death from any cause, whichever came first, asessed up to 30 days

  12. Number of days hospitalized after surgery

    Number of days hospitalized after surgery

    Measured: From 1 day after surgery until the date of hospital discharge or date of death from any cause, whichever came first, asessed up to 30 days

  13. Number of participants with pneumonia occurrence after surgery

    Number of participants with pneumonia occurrence within 1 week after surgery

    Measured: 1-7 days after surgery

  14. Number of participants with wound infection occurrence after surgery

    Number of participants with wound infection occurrence within 1 week after surgery

    Measured: 1-7 days after surgery

  15. Number of participants who underwent CRRT implementation after surgery

    Number of participants who underwent CRRT implementation within 1 week after surgery

    Measured: 1-7 days after surgery

  16. Number of participants with Atrial fibrillation occurrence after surgery

    Number of participants with Atrial fibrillation occurrence within 1 week after surgery

    Measured: 1-7 days after surgery

  17. Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence after surgery

    Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence within 1 week after surgery

    Measured: 1-7 days after surgery

  18. Changes in concentration of serum CRP level after surgery

    Changes in concentration of serum CRP level after surgery (between baseline and peak value within 1 week after surgery)

    Measured: 1-7 days after surgery

  19. Mortality within 30 days of surgery

    Mortality within 30 days of surgery

    Measured: 1-30 days after surgery

Timeline

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

  1. First posted23 Feb 2024
  2. Study start24 Nov 2022
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion31 Aug 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
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Treatment group: glycemic control using CGM Control group: glycemic control using arterial/venous blood sampling and POCT glucose
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06275971
Sponsor's protocol ID
KBSMC 2022-07-006
Status last verified
Feb 2024
First submitted
30 Jan 2024
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Moon SJ, Kim MS, Kim YT, Lee HE, Lee YW, Lee SJ, Chung ES, Park CY. Use of an insulin titration protocol based on continuous glucose monitoring in postoperative cardiac surgery patients with type 2 diabetes and prediabetes: a randomized controlled trial. Cardiovasc Diabetol. 2025 May 14;24(1):210. doi: 10.1186/s12933-025-02747-z.

    PubMed 40369552

Questions about this trial

What is this clinical trial studying?

A study testing Dexcom G6 and SMBG or venous/arterial blood glucose in people with Cardiac Disease and PreDiabetes, run by Kangbuk Samsung Hospital at 1 site in South Korea.

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 7 inclusion and 11 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 23 Feb 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 South Korea. 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 Cheol-Young Park, MD, PhD (+82220011550, cydoctor68@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time within the target range of 100-180 mg/dL (time frame: 1-7 days after surgery). 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 NCT06275971, which also lists 1 linked publication.

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 23 Feb 2024.

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