Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-03-05 @ 11:31 AM
Study NCT ID:
NCT02461394
Status:
COMPLETED
Last Update Posted:
2016-01-26
First Post:
2015-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
User Performance Evaluation of Contour Plus, Accu-Chek Active, Accu-Chek Performa and OneTouch Select Simple Blood Glucose Monitoring Systems Following ISO 15197:2013
Sponsor:
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Organization:
Study Overview
Official Title:
User Performance Evaluation of Contour Plus, Accu-Chek Active, Accu-Chek Performa and OneTouch Select Simple Blood Glucose Monitoring Systems Following ISO 15197:2013
Status:
COMPLETED
Status Verified Date:
2016-01
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:
None
Brief Summary:
The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour Plus (Bayer Healthcare Diabetes Care), Accu-Chek Active (Roche Diagnostics), Accu-Chek Performa (Roche Diagnostics) and OneTouch Select Simple (LifeScan) following ISO 15197:2013, clause 8.
The study will be performed in 2 parts. Each part will comprise testing of 2 BGMS.
For each BGMS, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects.
The same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).
The study will be performed in 2 parts. Each part will comprise testing of 2 BGMS.
For each BGMS, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects.
The same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: