Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
Undergoing cardiac surgery with cardiopulmonary bypass at Atrium Health Wake Forest Baptist Medical Center
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Dexcom G7 Continuous Glucose Monitor
DeviceDexcom 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Continuous Glucose MonitoringExperimental treatment 1 intervention
Trial outcomes
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 102
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 103
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 14
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 10Secondary 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 102
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 103
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 10Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: