Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575842
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Accuracy of Continuous Glucose Monitors During the Perioperative Period in Youth With Type 1 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is assessing the accuracy of continuous glucose monitors during surgical procedures requiring anesthesia
Detailed Description:
This study is an observational study design that includes collection of continuous glucose data and venous blood glucose data from either an IV or fingerstick from a blood glucose meter All subjects will be undergoing a surgical procedure that requires anesthesia The primary outcome of this study is to evaluate the accuracy of the CGM glucose values in comparison to the reference glucometer glucose value during anesthesia There is currently limited data on accuracy of CGMs during these events and therefore it is not know whether CGM glucose data is reliable to be used as the sole source of glucose monitoring during surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None