Perioperative Continuous Glucose Monitoring Accuracy in Cardiac Surgery

January 27, 2026 updated by: Karam Nam, MD, Seoul National University Hospital

Evaluation of Perioperative Continuous Glucose Monitoring Accuracy in Patients Undergoing Cardiac Surgery

The goal of this clinical trial is to evaluate accuracy of continuous glucose monitoring device called 'Dexcom G7' in patients undergoing cardiac surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who scheduled for cardiac surgery in Seoul National University Hospital

Description

Inclusion Criteria:

  • Patients aged 19 years or older scheduled for cardiac surgery

Exclusion Criteria:

  • Skin disease at the sensor application site (proximal arm)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CGM cohort
Application of perioperative continuous glucose monitoring
Device: Dexcom G7
Continuous glucose monitoring device (Dexcom G7) will be applied to patients undergoing cardiac surgery intraoperatively and postoperatively (maximum 10 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MARD
Time Frame: From the beginning of operation to the end of postoperative ICU stay (maximum 10 days)
mean absolute relative difference
From the beginning of operation to the end of postoperative ICU stay (maximum 10 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bland-Altman analysis
Time Frame: From the beginning of operation to the end of postoperative ICU stay (maximum 10 days)
mean difference, bias, 95% limits of agreement
From the beginning of operation to the end of postoperative ICU stay (maximum 10 days)
ISO criteria
Time Frame: From the beginning of operation to the end of postoperative ICU stay (maximum 10 days)
Satisfaction of 2013 ISO (International Organization of Standardization) criteria
From the beginning of operation to the end of postoperative ICU stay (maximum 10 days)
DTS error grid
Time Frame: From the beginning of operation to the end of postoperative ICU stay (maximum 10 days)
DTS (Diabtetes Technology Society) error grid
From the beginning of operation to the end of postoperative ICU stay (maximum 10 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CGM-CS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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