Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation
NCT ID: NCT02718703
Last Updated: 2016-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2015-02-28
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Blood Glucose monitoring System (BGMS)
Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)
Blood Glucose Monitoring System.
In vitro diagnostic medical device
Interventions
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Blood Glucose Monitoring System.
In vitro diagnostic medical device
Eligibility Criteria
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Inclusion Criteria
* User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.
Exclusion Criteria
* 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.
18 Years
45 Years
ALL
No
Sponsors
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LifeScan
INDUSTRY
Responsible Party
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Principal Investigators
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Lorna Stewart
Role: STUDY_DIRECTOR
LifeScan
Locations
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BioKinetic Europe Ltd
Belfast, Antrim, United Kingdom
Countries
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Other Identifiers
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3129822
Identifier Type: -
Identifier Source: org_study_id
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