Evaluating the Dexcom G7 glucose monitoring after heart surgery
Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery
This study is testing how well the Dexcom G7 glucose monitor works compared to regular blood tests for patients recovering from heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06338748 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the accuracy of the Dexcom G7 Continuous Glucose Monitoring System compared to traditional blood glucose monitoring methods in patients following cardiac surgery. Participants will have their blood glucose levels measured every 1-3 hours using both the Dexcom G7 and standard methods in the Cardiovascular Intensive Care Unit (CVICU) and on regular floors. The study will analyze the agreement and correlation between the two monitoring systems, as well as any errors that may occur. The Dexcom G7 will be applied by qualified medical personnel upon the patient's arrival in the CVICU.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for cardiothoracic surgery and will be admitted to the CVICU.
Not a fit: Patients with allergies to the materials used in the continuous glucose monitoring systems or those with certain skin conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance glucose monitoring accuracy for patients recovering from cardiac surgery, potentially improving their overall care.
How similar studies have performed: Previous studies have shown promise in the use of continuous glucose monitoring systems in various settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years old and above * Planned cardiothoracic surgery * Planned admission to Cleveland Clinic Main Campus building J5 or J6 or Q5 cardiovascular intensive care unit (CVICU) followed by transfer to the step down unit * With or without known diabetes (as 75% of patients entering the CVICU have hyperglycemia requiring intravenous insulin infusion) * If with known diagnosis of diabetes, diabetes can be type 1, type 2, or secondary (such as due to glucocorticoids or pancreatitis Exclusion Criteria: * Allergy to the material of the continuous glucose monitoring systems (CGMS) or the adhesive to be used * Skin conditions precluding the use of the CGMS * Pregnancy * Other conditions that the investigators deem inappropriate for the study * Patients receiving mechanical circulatory assist devices
Where this trial is running
Cleveland, Ohio
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Lansang Cecilia, MD — The Cleveland Clinic
- Study coordinator: Kimberly Jenkins, MSNM
- Email: jenkink@ccf.org
- Phone: (216) 445-4791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.