Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338748
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-03-23
Brief Title:
Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Accuracy of the Dexcom G7 Continuous Glucose Monitoring System Following Cardiac Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DexcomG7
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
Standard of care
Accuchek will be done per standard of care for post operative patients that are in ICU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None