Glucose Metabolism Disorders (Including Diabetes Mellitus)NCT06861881
Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass
A study testing Dexcom G7 Continuous Glucose Monitor in people with Glucose Metabolism Disorders (Including Diabetes Mellitus), run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glucose Metabolism Disorders (Including Diabetes Mellitus)
- What is being tested?
- Dexcom G7 Continuous Glucose Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Undergoing cardiac surgery with cardiopulmonary bypass at Atrium Health Wake Forest Baptist Medical Center
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Lynnette Harris, BSN, RN, 336-716-8791, Lynnette.Harris@Advocatehealth.org
Megan Hicks, MD
About this study
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.
Read the 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.
- Being tested
- Dexcom G7 Continuous Glucose Monitor
- Keywords
- continuous glucose monitoring, cardiopulmonary bypass, cardiac surgery
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G7 Continuous Glucose MonitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Dexcom G7 Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 10
Secondary outcomes (3)
Incidence of Continuous Glucose Monitor Malfunction
Number of times the Dexcom G7 continuous glucose monitor malfunctioned during use, including sensor loss or monitor failure.
Measured: 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.
Measured: 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.
Measured: Up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism Disorders (Including Diabetes Mellitus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Hicks, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861881
- Sponsor's protocol ID
- IRB00125789
- Status last verified
- Jan 2026
- First submitted
- 20 Feb 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No