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NCT Number: NCT06861881

Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass

The purpose of this research study is to test the accuracy of the Dexcom continuous glucose monitoring device during the cardiothoracic surgical procedure and recovery period in the Cardiac Intensive Care Unit. Readings from the device will be compared with the standard of care blood glucose levels that are obtained during your surgery and postoperatively.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location contact

Lynnette Harris, BSN, RN

CONTACT

[email protected]

336-716-8791

Megan Hicks, MD

PRINCIPAL_INVESTIGATOR

About this study

The proposed study would examine 100 adult patients specifically undergoing cardiac surgical procedures with the explicit goal of comparing continuous glucose monitoring accuracy to point-of-care testing, particularly in the setting of physiologic perturbations due to vasopressors, acidosis, and hypothermia. With a large sample size and few stipulations on the included patients, this well-powered study would give broadly applicable guidance regarding continuous glucose monitoring use in this population. The study would establish a pathway to further research regarding optimizing continuous glucose monitoring accuracy, providing earlier detection of out-of-range glucose values, improving the precision of insulin titration, and ultimately improving glucose control in the cardiac surgical population, which may improve patient outcomes, including mortality. This would be the first study to describe intraoperative use of the newest Dexcom continuous glucose monitoring device, the G7, which has the shortest available warmup time and may be the most accurate continuous glucose monitoring device on the market.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Undergoing cardiac surgery with cardiopulmonary bypass at Atrium Health Wake Forest Baptist Medical Center

Exclusion criteria

  • Under 18 years of age
  • Pregnant women
  • Patients with a contraindication to device placement on the posterior arm, including rash, missing extremity, or existing line or device

Treatment and study plan

Dexcom G7 Continuous Glucose Monitor

Device

Dexcom G7 continuous glucose monitor will be placed prior to cardiac surgery. It will be worn continuously throughout the perioperative period and during the time admitted to the Cardiovascular Intensive Care Unit.

Primary outcomes

  1. Continuous Glucose Monitoring Accuracy Compared to Point-of-Care Measurements

    Time frame: Up to Day 10

    Glucose values (mg/dL) from the continuous glucose monitoring will be compared to glucose values obtained from point-of-care arterial blood gas and/or fingerstick capillary glucose measurements.

  2. Percentage of Continuous Glucose Monitoring Accuracy with Vasopressor Use

    Time frame: Up to Day 10

    Glucose values from the continuous glucose monitoring will be compared to glucose values obtained from point-of-care arterial blood gas measurements when vasopressors are utilized for hemodynamic optimization.

  3. Percentage of Continuous Glucose Monitoring Accuracy with Hypothermia

    Time frame: Day 1

    Glucose values from the continuous glucose monitoring will be compared to glucose values obtained from point-of-care arterial blood gas measurements during the hypothermic period intraoperatively.

  4. Percentage of Continuous Glucose Monitoring Accuracy with Acidosis

    Time frame: Up to Day 10

    Glucose values from the continuous glucose monitoring will be compared to glucose values obtained from point-of-care arterial blood gas measurements intraoperatively when the participant is acidotic.

Secondary outcomes

  1. Incidence of Continuous Glucose Monitor Malfunction

    Time frame: Up to Day 10

    Number of times the Dexcom G7 continuous glucose monitor malfunctioned during use, including sensor loss or monitor failure.

  2. Duration of Time Continuous Glucose Monitor Experienced Sensor Loss

    Time frame: Up to Day 10

    Amount of time the Dexcom G7 continuous glucose monitor experienced sensor loss while in use.

  3. Continuous Glucose Monitor Measurement Expenses

    Time frame: Up to Day 10

    Total expenditures to the patient for the costs of all glucose measurements (arterial blood gases, glucometers as point of care, laboratory drawn glucose measurements - included in metabolic profile laboratory measurements as well) obtained during the course of wearing the continuous glucose monitoring device compared to the cost of the Dexcom G7 continuous glucose monitor.

Study contacts

Contact information is provided by the study sponsor or research team.

Lynnette Harris, BSN RN

CONTACT

[email protected]

336-716-8791

Megan H Hicks, MD

CONTACT

[email protected]

336-716-4498

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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