Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT03085251
Status:
COMPLETED
Last Update Posted:
2017-09-26
First Post:
2017-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)
Sponsor:
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Organization:
Study Overview
Official Title:
Clinical System Accuracy Evaluation With OneTouch® Verio Flex Blood Glucose Monitoring System (BGMS)
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 objective of this study is the evaluation of system accuracy based on EN ISO 15197:2015 (ISO 15197:2013), clause 6.3 in which accuracy requirements and applicable test procedures for blood glucose monitoring systems intended for self-monitoring of blood glucose by patients are stipulated. ISO 15197:20132 was harmonized with the regulations of the European Union as EN ISO 15197:2015. This harmonization had no impact on the requirements and procedu¬res in ISO 15197:2013; changes were made to the foreword and an informative annex. In this study, system accuracy evaluation will be performed for OneTouch® Verio Flex (LifeScan Europe) on behalf of LifeScan Scotland Limited (customer) with three different reagent system lots.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: