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

NCT02767336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2016-09-14

No results posted yet for this study

Summary

Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation.

Conditions

Interventions

DEVICE

Blood Glucose Monitoring System.

In vitro diagnostic medical device

Sponsors & Collaborators

  • Bio-Kinetic Europe, Ltd.

    collaborator INDUSTRY

  • LifeScan

    lead INDUSTRY

Principal Investigators

  • Lorna Stewart · LifeScan Scotland Ltd

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02767336 on ClinicalTrials.gov