Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation

Diabetes Mellitus Clinical Trial

Official title:

Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718703
• Other study ID #: 3129822
• Status: Completed
• Phase: N/A
• First received: March 1, 2016
• Last updated: September 12, 2016
• Start date: February 2015
• Est. completion date: March 2015

Study information

• Verified date: September 2016
• Source: LifeScan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Blood Glucose Monitoring System.
In vitro diagnostic medical device

Locations

Country	Name	City	State
United Kingdom	BioKinetic Europe Ltd	Belfast	Antrim

Sponsors (1)

Lead Sponsor	Collaborator
LifeScan

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	User Performance (UP) evaluation - blood glucose level: BGMS vs reference instrument.	UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP ( HealthCare Professional)	Up to 1 hour	No
Primary	System Accuracy (SA) evaluation - blood glucose level: BGMS vs reference instrument.	Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.	Up to 1 hour	No
Primary	System Use Evaluation - HCP ( HealthCare Professional) questionnaire	Assessing use of BGMS and supporting material by subject.	Up to 1 hour	No