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Project Frazier 3 Regulatory Clinical Evaluation

Sponsor
LifeScan Scotland Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT03515421
Collaborator
Institute for Diabetes-Technology GmbH (Other)
379
Enrollment
4
Locations
1
Arm
2.3
Actual Duration (Months)
94.8
Patients Per Site
41.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

Condition or Disease Intervention/Treatment Phase
  • Device: Frazier 3 Verio
  • Device: Frazier 3 UltraPlus
 N/A

Detailed Description

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

Study Design

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

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument. [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. [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 [Up to 15 minutes]

    Assessment of how the patient uses the BGMS.

  4. Instructions for Use Evaluation questionnaire. [Up to 10 days.]

    Questionnaires to assess the effectiveness of the instructions for use.

  5. Marketing Claims Evaluation questionnaire. [Up to 10 days]

    Assess Lay User Acceptance of the Frazier 3 BGMSs in support of marketing claims.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut für Diabetes-Technologie Ulm Germany D-89081
2 Diabetes Centre Birmingham United Kingdom B9 5SS
3 Royal Infirmary of Edinburgh Edinburgh United Kingdom EH16 4SA
4 Centre for Health Science Inverness United Kingdom IV2 3JH

Sponsors and Collaborators

  • LifeScan Scotland Ltd
  • Institute for Diabetes-Technology GmbH

Investigators

  • Study Director: Lorna Stewart, LifeScan Scotland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
LifeScan Scotland Ltd
ClinicalTrials.gov Identifier:
NCT03515421
Other Study ID Numbers:
  • 3165622
First Posted:
May 3, 2018
Last Update Posted:
Sep 10, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 10, 2020