NCT06861881

Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glucose Metabolism Disorders (Including Diabetes Mellitus)

Interventions

Type	Name	Description
DEVICE	Dexcom G7 Continuous Glucose Monitor	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-03-06
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study