System Accuracy and User Performance of Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus
NCT02290067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2014-12-23
Summary
The aim of this test is to determine the system accuracy and user performance evaluation of three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data should cover the whole range of glucose concentration which could usually be expected in patients with diabetes mellitus.
Conditions
Interventions
- DEVICE
-
Blood glucose monitoring system (Omnitest 3)
- DEVICE
-
Blood glucose monitoring system (Omnitest 5)
- DEVICE
-
Blood glucose monitoring system (Omnitest 5D)
Sponsors & Collaborators
-
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
collaborator OTHER -
B. Braun Melsungen AG
lead INDUSTRY
Principal Investigators
-
Nina Jendrike, Dr. med. · Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-10-31
- Primary Completion
- 2014-11-30
- Completion
- 2014-11-30
Countries
- Germany
Study Locations
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