- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02718703
Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation
September 12, 2016 updated by: LifeScan
Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Antrim
-
Belfast, Antrim, United Kingdom, BT2 7BA
- BioKinetic Europe Ltd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Summary of 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)
|
In vitro diagnostic medical device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
User Performance (UP) evaluation - blood glucose level: BGMS vs reference instrument.
Time Frame: Up to 1 hour
|
UP evaluation of blood glucose monitoring systems compared to a reference instrument.
Samples collected by subject and HCP ( HealthCare Professional)
|
Up to 1 hour
|
System Accuracy (SA) evaluation - blood glucose level: BGMS vs reference instrument.
Time Frame: Up to 1 hour
|
Accuracy verification of blood glucose monitoring systems compared to a reference instrument.
Samples collected by HCP only.
|
Up to 1 hour
|
System Use Evaluation - HCP ( HealthCare Professional) questionnaire
Time Frame: Up to 1 hour
|
Assessing use of BGMS and supporting material by subject.
|
Up to 1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Lorna Stewart, LifeScan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
March 1, 2016
First Submitted That Met QC Criteria
March 18, 2016
First Posted (Estimate)
March 24, 2016
Study Record Updates
Last Update Posted (Estimate)
September 14, 2016
Last Update Submitted That Met QC Criteria
September 12, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 3129822
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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