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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan H Hicks, MD | Contact | 336-716-4498 | Megan.Hicks@wfusm.edu | |
| Lynnette Harris, BSN RN | Contact | 336-716-8791 | Lynnette.Harris@Advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Megan Hicks, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |