ClinicalTrials.gg
RecruitingNCT06861881Updated Nov 9, 2026

Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass

An interventional study of Dexcom G7 Continuous Glucose Monitor in Glucose Metabolism Disorders (Including Diabetes Mellitus), sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Device feasibility

Updated Nov 9, 2026Now RecruitingSite recruiting status changed+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Glucose Metabolism Disorders (Including Diabetes Mellitus)

Keywords

  • continuous glucose monitoring
  • cardiopulmonary bypass
  • cardiac surgery
03

In context

Glucose Metabolism Disorders

361 studies on the registry are indexed under Glucose Metabolism Disorders; 38 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 308 interventional studies indexed under Glucose Metabolism Disorders.

Browse Glucose Metabolism Disorders studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.

Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • Under 18 years of age
  • Pregnant women
  • Patients with a to device placement on the posterior arm, including rash, missing extremity, or existing line or device
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceDexcom 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to Day 10

  2. 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.

    Time frame: Up to Day 10

  3. 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.

    Time frame: Day 1

  4. 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.

    Time frame: Up to Day 10

Secondary outcomes

  1. Incidence of Continuous Glucose Monitor Malfunction

    Number of times the Dexcom G7 continuous glucose monitor malfunctioned during use, including sensor loss or monitor failure.

    Time frame: Up to Day 10

  2. Duration of Time Continuous Glucose Monitor Experienced Sensor Loss

    Amount of time the Dexcom G7 continuous glucose monitor experienced sensor loss while in use.

    Time frame: Up to Day 10

  3. 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.

    Time frame: Up to Day 10

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2026 (actual). Primary completion is estimated for Nov 2027, 12 months after the start.

Of 106 non-industry interventional studies with no phase under Glucose Metabolism Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 40. This study's planned 12 months is below that.

Counting every sponsor, half of 119 studies reached it within 19 months; a quarter within 7 and three quarters within 40.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 23, 2026: start Oct 2026 → Nov 2026, primary completion Oct 2026 → Nov 2027 and completion Oct 2026 → Nov 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2025
First posted
Mar 6, 2025
StartActual
Nov 3, 2026was Oct 2026
Primary completionEst.
Nov 2027was Oct 2026
CompletionEst.
Nov 2027was Oct 2026
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Nov 9, 2026
Sites
Wake Forest University Health Sciences is now Recruiting
Nov 9, 2026
Start date
Oct 2026→Nov 2026
Oct 23, 2026
Primary completion
Oct 2026→Nov 2027
Oct 23, 2026
Study completion
Oct 2026→Nov 2027
Oct 23, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Wake Forest University Health Sciences · Winston-Salem, United StatesContact added m•••@wfusm.edu · •••4498
Nov 9, 2026
Show all 2 updates
  1. Nov 9, 2026
    Not yet recruiting→Recruiting
    Wake Forest University Health Sciences is now Recruiting
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Wake Forest University Health Sciences · Winston-Salem, United StatesContact added m•••@wfusm.edu · •••4498
    + 2 other changes: verification date and date precision
  2. Oct 23, 2026
    Start date Oct 2026→Nov 2026
    Primary completion Oct 2026→Nov 2027
    Study completion Oct 2026→Nov 2027

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06861881
Responsible party
Sponsor
First posted
Mar 6, 2025
Start date
Nov 3, 2026
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Nov 9, 2026

Study contacts

Megan H Hicks, MD
Contact
Megan.Hicks@wfusm.edu
336-716-4498
Lynnette Harris, BSN RN
Contact
Lynnette.Harris@Advocatehealth.org
336-716-8791
Megan Hicks, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion