Project Frazier 3 Regulatory Clinical Evaluation
- Conditions
- Healthy VolunteersDiabetes Mellitus
- Registration Number
- NCT03515421
- Lead Sponsor
- LifeScan Scotland Ltd
- Brief Summary
Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)
- Detailed Description
User performance, system use, system accuracy, user instruction for use and marketing claims evaluation of Blood Glucose Monitoring Systems.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 379
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument. Up to 1 hour UP evaluation of blood glucose monitoring systems compared to a reference instrument. BGMSs samples collected by subject and reference samples collected by HCP ( Health Care Professional)
Instructions for Use Evaluation questionnaire. Up to 10 days. Questionnaires to assess the effectiveness of the instructions for use.
System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs vs reference instrument. Up to 1 hour Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.
System Use Evaluation questionnaire Up to 15 minutes Assessment of how the patient uses the BGMS.
Marketing Claims Evaluation questionnaire. Up to 10 days Assess Lay User Acceptance of the Frazier 3 BGMSs in support of marketing claims.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Institut für Diabetes-Technologie
🇩🇪Ulm, Germany
Diabetes Centre
🇬🇧Birmingham, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Centre for Health Science
🇬🇧Inverness, United Kingdom
Institut für Diabetes-Technologie🇩🇪Ulm, Germany