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CompletedNCT03515421Updated Sep 10, 2020

Project Frazier 3 Regulatory Clinical Evaluation

An interventional study of Frazier 3 Verio and Frazier 3 UltraPlus in Diabetes Mellitus and Healthy Volunteers, sponsored by LifeScan Scotland Ltd. Completed at 4 sites in 2 countries. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-10.

Sponsored by LifeScan Scotland Ltd · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
379
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study summary

Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

Read the detailed description

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

02

Conditions studied

  • Diabetes Mellitus
  • Healthy Volunteers
03

In context

Lead sponsor

LifeScan Scotland Ltd is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
379 participants (actual)

Study arms

  • 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 · Device: Frazier 3 UltraPlus

Interventions

  • DeviceFrazier 3 Verio

    In vitro diagnostic device (IVDD)

  • DeviceFrazier 3 UltraPlus

    In vitro diagnostic device (IVDD)

06

What researchers measure

Primary outcomes

  1. User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument.

    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)

    Time frame: Up to 1 hour

  2. System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs vs reference instrument.

    Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.

    Time frame: Up to 1 hour

  3. System Use Evaluation questionnaire

    Assessment of how the patient uses the BGMS.

    Time frame: Up to 15 minutes

  4. Instructions for Use Evaluation questionnaire.

    Questionnaires to assess the effectiveness of the instructions for use.

    Time frame: Up to 10 days.

  5. Marketing Claims Evaluation questionnaire.

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

    Time frame: Up to 10 days

07

Study locations

4 sites
  • Institut für Diabetes-Technologie
    Ulm, D-89081, Germany
  • Diabetes Centre
    Birmingham, B9 5SS, United Kingdom
  • Royal Infirmary of Edinburgh
    Edinburgh, EH16 4SA, United Kingdom
  • Centre for Health Science
    Inverness, IV2 3JH, United Kingdom
08

References and documents

Publications

  • Katz LB, Stewart L, Guthrie B, Cameron H. Patient Satisfaction With a New, High Accuracy Blood Glucose Meter That Provides Personalized Guidance, Insight, and Encouragement. J Diabetes Sci Technol. 2020 Mar;14(2):318-323. doi: 10.1177/1932296819867396. Epub 2019 Aug 2. PubMed 31375031 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03515421
Lead sponsor
LifeScan Scotland Ltd
Collaborators
Institute for Diabetes-Technology GmbH
Responsible party
Sponsor
First posted
May 3, 2018
Start date
Apr 9, 2018
Primary completion
Jun 18, 2018
Completion
Jun 18, 2018
Last update
Sep 10, 2020

Study contacts

Lorna Stewart
study director · LifeScan Scotland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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