Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04577976
Status:
TERMINATED
Last Update Posted:
2022-08-11
First Post:
2020-09-28
Brief Title:
FreeStyle Libre 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG
Sponsor:
Abbott Diabetes Care
Organization:
Abbott Diabetes Care
Study Overview
Official Title:
FreeStyle Libre 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective multi-center non-randomized single-arm study intended to characterize the safety of self-monitoring of blood glucose SMBG when used to manage diabetes in pediatric patients
Detailed Description:
Approximately 400 subjects aged 4-17 years and older with type 1 or type 2 diabetes who require daily blood glucose monitoring to manage their diabetes will be enrolled in the study Subjects andor their caregivers will utilize capillary SMBG for managing diabetes for 6 months Subjects andor their caregivers will maintain a diarylog book of Adverse Events experienced during the duration of the study Assessment of Adverse Events will occur via self reporting at each monthly visit andor phone call
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