Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation
Not Applicable
Completed
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT02718703
- Lead Sponsor
- LifeScan
- Brief Summary
Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- Able to voluntarily provide written informed consent to participate in the study.
- User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.
Exclusion Criteria
- Female subjects who are pregnant or lactating.
- Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
- User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method User Performance (UP) evaluation - blood glucose level: BGMS vs reference instrument. Up to 1 hour UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP ( HealthCare Professional)
System Accuracy (SA) evaluation - blood glucose level: BGMS 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 - HCP ( HealthCare Professional) questionnaire Up to 1 hour Assessing use of BGMS and supporting material by subject.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
BioKinetic Europe Ltd
🇬🇧Belfast, Antrim, United Kingdom
BioKinetic Europe Ltd🇬🇧Belfast, Antrim, United Kingdom