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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Blood Glucose Monitoring System.

• 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

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-24
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-14

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

Arm && Interventions

Group	Intervention	Description
Blood Glucose monitoring System (BGMS)	Blood Glucose Monitoring System.	Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)

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.

Trial Locations

Locations (1)

BioKinetic Europe Ltd; 🇬🇧 Belfast, Antrim, United Kingdom