Project Frazier 3 Regulatory Clinical Evaluation

September 8, 2020 updated by: LifeScan Scotland Ltd
Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

User performance, system use, system accuracy, user instruction for use and marketing claims evaluation of Blood Glucose Monitoring Systems.

Study Type

Interventional

Enrollment (Actual)

379

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

  • Germany
      • Ulm, Germany, D-89081
        • Institut für Diabetes-Technologie
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Diabetes Centre
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • Inverness, United Kingdom, IV2 3JH
        • Centre for Health Science

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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Summary of Inclusion Criteria

  • Age - Subject is at least 12 years old.
  • Informed Consent - Subject reads the appropriate Participant Information Sheet and signs the Informed Consent Form (section 12.0).
  • Diabetes Diagnosis when applicable - type 1 or type 2 diabetes mellitus.
  • Language - Subject reads and understands local language
  • SMBG status confirmed
  • Subject agrees to complete all aspects of the study

Summary of exclusion criteria

  • Conflict of Interest
  • Pregnancy - Subject is pregnant (as confirmed by Subject)
  • User Performance Accuracy Testing - Technical Expertise

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

  • Primary Purpose: Other
  • 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 Systems (BGMSs): Frazier 3 Verio and Frazier 3 UltraPLus.

Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)
Device: Frazier 3 Verio
In vitro diagnostic device (IVDD)
Device: Frazier 3 UltraPlus
In vitro diagnostic device (IVDD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. BGMSs samples collected by subject and reference samples collected by HCP ( Health Care Professional)
Up to 1 hour
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
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 10 days.
Questionnaires to assess the effectiveness of the instructions for use.
Up to 10 days.
Marketing Claims Evaluation questionnaire.
Time Frame: Up to 10 days
Assess Lay User Acceptance of the Frazier 3 BGMSs in support of marketing claims.
Up to 10 days

Collaborators and Investigators

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

Sponsor

LifeScan Scotland Ltd

Collaborators

Institute for Diabetes-Technology GmbH

Investigators

  • Study Director: Lorna Stewart, LifeScan Scotland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 9, 2018

Primary Completion (Actual)

June 18, 2018

Study Completion (Actual)

June 18, 2018

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 3, 2018

Study Record Updates

Last Update Posted (Actual)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 3165622

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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