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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Intervention / Treatment: Device: Dexcom G7 Continuous Glucose Monitor

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan H Hicks, MD; Phone Number: 336-716-4498; Email: Megan.Hicks@wfusm.edu
• Study Contact Backup: Name: Lynnette Harris, BSN RN; Phone Number: 336-716-8791; Email: Lynnette.Harris@Advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
      • Principal Investigator: Megan Hicks, MD
      • Contact: Lynnette Harris, BSN, RN; Phone Number: 336-716-8791; Email: Lynnette.Harris@Advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Glucose Monitoring; All participants will wear the Dexcom G7 continuous glucose monitor continuously during their cardiothoracic surgery and throughout their time admitted to the Cardiovascular Intensive Care Unit.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Glucose Monitoring Accuracy Compared to Point-of-Care Measurements	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.	Up to Day 10
Percentage of Continuous Glucose Monitoring Accuracy with Vasopressor Use	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.	Up to Day 10
Percentage of Continuous Glucose Monitoring Accuracy with Hypothermia	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.	Day 1
Percentage of Continuous Glucose Monitoring Accuracy with Acidosis	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.	Up to Day 10

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Megan Hicks, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: cardiac surgery; cardiopulmonary bypass; continuous glucose monitoring
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: IRB00125789

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.: No