Project Frazier 3 Regulatory Clinical Evaluation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03515421

Enrollment

379

Registered

2018-05-03

Start date

2018-04-09

Completion date

2018-06-18

Last updated

2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Healthy Volunteers

Brief summary

Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

Detailed description

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

Interventions

DEVICEFrazier 3 Verio

In vitro diagnostic device (IVDD)

DEVICEFrazier 3 UltraPlus

In vitro diagnostic device (IVDD)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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)
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.
System Use Evaluation questionnaire	Up to 15 minutes	Assessment of how the patient uses the BGMS.
Instructions for Use Evaluation questionnaire.	Up to 10 days.	Questionnaires to assess the effectiveness of the instructions for use.
Marketing Claims Evaluation questionnaire.	Up to 10 days	Assess Lay User Acceptance of the Frazier 3 BGMSs in support of marketing claims.

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026