Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-03-06 @ 6:02 AM
Study NCT ID:
NCT02073058
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2014-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System
Sponsor:
Abbott Diabetes Care
Organization:
Study Overview
Official Title:
Evaluation of the Accuracy of the Abbott Sensor Based Interstitial Glucose Monitoring System
Status:
COMPLETED
Status Verified Date:
2014-05
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:
None
Brief Summary:
The purpose of this study is to demonstrate point accuracy of the Abbott Sensor Based Glucose Monitoring (GM) System interstitial glucose results against Reader capillary Blood Glucose (BG) reference using the Consensus Error Grid. During the course of the wear duration, the subject is required to test fingerstick glucose measurement at least eight (8) times a day for capillary reference glucose measurements and three in-clinic visits of a maximum 13 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:
False
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?: