Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT02390167
Status:
COMPLETED
Last Update Posted:
2019-07-17
First Post:
2015-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System
Sponsor:
Ascensia Diabetes Care
Organization:
Study Overview
Official Title:
User Performance of the ONYX NEXT Blood Glucose Monitoring System
Status:
COMPLETED
Status Verified Date:
2017-03
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 was to determine if untrained subjects with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
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?: