Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass

NCT06861881 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB00125789
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Metabolism Disorders (Including Diabetes Mellitus)

Keywords

continuous glucose monitoring; cardiopulmonary bypass; cardiac surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Incidence of Continuous Glucose Monitor Malfunction

  Up to Day 10

• Duration of Time Continuous Glucose Monitor Experienced Sensor Loss

  Up to Day 10

• Continuous Glucose Monitor Measurement Expenses

  Up to Day 10

Study Arms (1)

Continuous Glucose Monitoring

EXPERIMENTAL

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

Interventions

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.

Continuous Glucose Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Megan Hicks, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan H Hicks, MD

CONTACT

336-716-4498; Megan.Hicks@wfusm.edu

Lynnette Harris, BSN RN

CONTACT

336-716-8791; Lynnette.Harris@Advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 6, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)