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Project Frazier 3 Regulatory Clinical Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515421
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
Institute for Diabetes-Technology GmbH
Information provided by (Responsible Party):
LifeScan

Brief Summary:
Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Healthy Volunteers Device: Frazier 3 Verio Device: Frazier 3 UltraPlus Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 379 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Project Frazier 3 Regulatory Clinical Evaluation
Actual Study Start Date : April 9, 2018
Actual Primary Completion Date : June 18, 2018
Actual Study Completion Date : June 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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)




Primary Outcome Measures :
  1. 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)

  2. 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.

  3. System Use Evaluation questionnaire [ Time Frame: Up to 15 minutes ]
    Assessment of how the patient uses the BGMS.

  4. Instructions for Use Evaluation questionnaire. [ Time Frame: Up to 10 days. ]
    Questionnaires to assess the effectiveness of the instructions for use.

  5. Marketing Claims Evaluation questionnaire. [ Time Frame: Up to 10 days ]
    Assess Lay User Acceptance of the Frazier 3 BGMSs in support of marketing claims.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515421


Locations
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Germany
Institut für Diabetes-Technologie
Ulm, Germany, D-89081
United Kingdom
Diabetes Centre
Birmingham, United Kingdom, B9 5SS
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Centre for Health Science
Inverness, United Kingdom, IV2 3JH
Sponsors and Collaborators
LifeScan
Institute for Diabetes-Technology GmbH
Investigators
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Study Director: Lorna Stewart LifeScan Scotland

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Responsible Party: LifeScan
ClinicalTrials.gov Identifier: NCT03515421    
Other Study ID Numbers: 3165622
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No