Ignite Creation Date:
2024-05-06 @ 1:57 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01932944
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2013-08-28
Brief Title:
Accuracy Characterization Study
Sponsor:
Abbott Diabetes Care
Organization:
Abbott Diabetes Care
Study Overview
Official Title:
Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System Compared to Venous and Capillary Glucose
Status:
COMPLETED
Status Verified Date:
2017-01
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:
ACS
Brief Summary:
To demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring System System interstitial glucose results against venous glucose reference and capillary fingerstick using the Consensus Error Grid over the wear duration During the course of the wear duration the subject is required to be testing fingerstick glucose measurement at least 8 times a day for capillary reference glucose measurements and three in-clinic visits of maximum 10 hours each for venous reference glucose measurements With every reference measurement the subject or study staff will perform a measurement on the System
Detailed Description:
None
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