Clinical trial NCT06861881: Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass
Official title: Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus)
Keywords: continuous glucose monitoring
cardiopulmonary bypass
cardiac surgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continuous Glucose Monitoring Accuracy Compared to Point-of-Care Measurements
timeFrame: Up to Day 10
measure: Percentage of Continuous Glucose Monitoring Accuracy with Vasopressor Use
timeFrame: Up to Day 10
measure: Percentage of Continuous Glucose Monitoring Accuracy with Hypothermia
timeFrame: Day 1
measure: Percentage of Continuous Glucose Monitoring Accuracy with Acidosis
timeFrame: Up to Day 10
Secondary outcomes:
measure: Incidence of Continuous Glucose Monitor Malfunction
timeFrame: Up to Day 10
measure: Duration of Time Continuous Glucose Monitor Experienced Sensor Loss
timeFrame: Up to Day 10
measure: Continuous Glucose Monitor Measurement Expenses
timeFrame: Up to Day 10
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Megan Hicks, MD
role: PRINCIPAL_INVESTIGATOR
References: