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Not yet recruiting NCT06861881

Continuous Glucose Monitoring in Patients Undergoing Cardiopulmonary Bypass

No phase Interventional Glucose Metabolism Disorders (Including Diabetes Mellitus)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexcom G7 Continuous Glucose Monitor.
Who it may be relevant to
Registry conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Interventions

  • Device Dexcom 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.

Primary outcome measures

  • Continuous Glucose Monitoring Accuracy Compared to Point-of-Care Measurements [Time frame: Up to Day 10]
  • Percentage of Continuous Glucose Monitoring Accuracy with Vasopressor Use [Time frame: Up to Day 10]
  • Percentage of Continuous Glucose Monitoring Accuracy with Hypothermia [Time frame: Day 1]
  • Percentage of Continuous Glucose Monitoring Accuracy with Acidosis [Time frame: Up to Day 10]
Secondary outcome measures (3)
  • Incidence of Continuous Glucose Monitor Malfunction [Time frame: Up to Day 10]
  • Duration of Time Continuous Glucose Monitor Experienced Sensor Loss [Time frame: Up to Day 10]
  • Continuous Glucose Monitor Measurement Expenses [Time frame: Up to Day 10]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT06861881 · IRB00125789

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗