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

Overview

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

Full Title of Study: “Project Bloom Regulatory Clinical Evaluation – System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2016

Interventions

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

Arms, Groups and Cohorts

  • 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)

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • 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.
  • System Use Evaluation questionnaire.
    • Time Frame: Up to 15 minutes
    • Assessment of how the patient uses the BGMS.
  • Instructions for Use Evaluation questionnaire.
    • Time Frame: Up to 6 days.
    • Questionnaires to assess the effectiveness of the instructions for use.
  • Marketing Claims Evaluation questionnaire.
    • Time Frame: Up to 6 days.
    • Assess Lay User Acceptance of the Bloom BGMS in support of marketing claims.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LifeScan
  • Collaborator
    • Bio-Kinetic Europe, Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lorna Stewart, Study Director, LifeScan Scotland Ltd

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