Clinical trial NCT06338748: Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery
Official title: Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Continuous Glucose Monitoring
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2024-04-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients undergoing heart surgery at the Cleveland Clinic (main campus) who would normally be tested for high sugar levels by poking a finger and using a test strip.
Primary purpose: OTHER

Brief summary: This is a prospective longitudinal study to study the agreement between a continuous glucose monitoring system (CGMS) versus current blood glucose monitoring. Subjects in this study will have their blood glucose measured regularly every 1-3 hours with current methods in the Cardiovascular Intensive Care Unit (CVICU), and by Point of Care (POC) fingerstick glucose using the Accucheck Inform II on the regular floors, and the CGMS reading at the same time will be captured. Subjects will have measurements taken throughout their stay in the CVICU and on the regular floors. Agreement and correlation between systems, as well as errors, will be calculated.

Detailed description: The Dexcom G7 will be placed either by an anesthesiologist or nurse anesthetist, or critical care physician, nurse or nurse manager upon arrival to CVICU, post cardiac surgery.

Standard of care:

Accuchek will be done per standard of care for post operative patients that are in ICU

Eligibility 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

Primary outcomes:
measure: Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from arterial blood gas (ABG) or peripheral/central venous catheter or fingerstick point of care (POC) while patients are in the CVICU
timeFrame: 1 - 10 days
measure: Compare accuracy of glucose readings obtained from Dexcom G7 compared to blood glucose obtained from fingerstick POC glucose when patients are on the regular floors
timeFrame: 1 - 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Lansang Cecilia, MD
role: PRINCIPAL_INVESTIGATOR
References: