Ignite Creation Date:
2024-05-06 @ 9:39 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03033849
Status:
COMPLETED
Last Update Posted:
2017-09-12
First Post:
2017-01-16
Brief Title:
User Performance Evaluation of Contour Next One Accu-Chek Aviva Connect FreeStyle Freedom Lite OneTouch Verio and GlucoMen Areo Blood Glucose Monitoring Systems Following ISO 151972013
Sponsor:
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Organization:
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Study Overview
Official Title:
User Performance Evaluation of Contour Next One Accu-Chek Aviva Connect FreeStyle Freedom Lite OneTouch Verio and GlucoMen Areo Blood Glucose Monitoring Systems Following ISO 151972013
Status:
COMPLETED
Status Verified Date:
2017-09
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 Next One Ascensia Diabetes Care GmbH Accu-Chek Aviva Connect Roche Diabetes Care GmbH FreeStyle Freedom Lite Abbott Diabetes Care Inc OneTouch Verio LifeScan Europe and GlucoMen areo A Menarini Diagnostics Srl based on ISO 151972013 EN ISO 151972015 clause 8
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
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:
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