Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass

Not Applicable

Not yet recruiting

• Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus)

• Registration Number: NCT06861881
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-06
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24
• Study Start: 2025-10
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Continuous Glucose Monitoring Accuracy Compared to Point-of-Care Measurements	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.
Percentage of Continuous Glucose Monitoring Accuracy with Vasopressor Use	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.
Percentage of Continuous Glucose Monitoring Accuracy with Hypothermia	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.
Percentage of Continuous Glucose Monitoring Accuracy with Acidosis	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 Outcome Measures

Name	Time	Method
Incidence of Continuous Glucose Monitor Malfunction	Up to Day 10	Number of times the Dexcom G7 continuous glucose monitor malfunctioned during use, including sensor loss or monitor failure.
Duration of Time Continuous Glucose Monitor Experienced Sensor Loss	Up to Day 10	Amount of time the Dexcom G7 continuous glucose monitor experienced sensor loss while in use.
Continuous Glucose Monitor Measurement Expenses	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.

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States