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

September 12, 2016 updated by: LifeScan

Project Bloom Regulatory Clinical Evaluation - System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

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

  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Diabetes Centre, Heartlands Hospital
      • Edinburgh, United Kingdom, EH16 4SA
        • NHS Lothian
      • Inverness, United Kingdom, IV2 3JH
        • Highland Diabetes Institute
    • 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

6 years and older (Child, Adult, Older 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.
  • For subjects participating in the In Vivo Glucose adjustment procedure age range is 18 - 45.

Summary of 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)
Device: Blood Glucose Monitoring System.
In vitro diagnostic medical device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs 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
User Performance (UP) evaluation measured by blood glucose level (mg/dl) of 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 ( Health Care Professional)
Up to 1 hour
System Use Evaluation questionnaire.
Time Frame: Up to 15 minutes
Assessment of how the patient uses the BGMS.
Up to 15 minutes
Instructions for Use Evaluation questionnaire.
Time Frame: Up to 6 days.
Questionnaires to assess the effectiveness of the instructions for use.
Up to 6 days.
Marketing Claims Evaluation questionnaire.
Time Frame: Up to 6 days.
Assess Lay User Acceptance of the Bloom BGMS in support of marketing claims.
Up to 6 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeScan

Collaborators

Bio-Kinetic Europe, Ltd.

Investigators

  • Study Director: Lorna Stewart, LifeScan Scotland Ltd

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

April 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (Estimate)

May 10, 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

  • 3141352 and 3141353

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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