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

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

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioKinetic Europe Ltd

Belfast, Antrim, BT2 7BA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Glucose Monitoring System.

Device

In vitro diagnostic medical device

Primary outcomes

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)
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.
System Use Evaluation - HCP ( HealthCare Professional) questionnaire

Time frame: Up to 1 hour

Assessing use of BGMS and supporting material by subject.

Sponsors and collaborators

Lead sponsor

LifeScan

Industry

Registry information

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Mar 24, 2016
Registry last updated: Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed