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NCT03515421 Clinical Trial

Project Frazier 3 Regulatory Clinical Evaluation

Healthy Volunteers Clinical Trial

Official title:
Project Frazier 3 Regulatory Clinical Evaluation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03515421
Other study ID # 3165622
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 9, 2018
Est. completion date June 18, 2018

Study information
Verified date September 2020
Source LifeScan Scotland Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 379
Est. completion date June 18, 2018
Est. primary completion date June 18, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Frazier 3 Verio
In vitro diagnostic device (IVDD)
• Frazier 3 UltraPlus
In vitro diagnostic device (IVDD)

Locations
Country Name City State
Germany Institut für Diabetes-Technologie Ulm
United Kingdom Diabetes Centre Birmingham
United Kingdom Royal Infirmary of Edinburgh Edinburgh
United Kingdom Centre for Health Science Inverness

Sponsors (2)
Lead Sponsor Collaborator
LifeScan Scotland Ltd Institute for Diabetes-Technology GmbH

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) Up to 1 hour
Primary 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. Up to 1 hour
Primary System Use Evaluation questionnaire Assessment of how the patient uses the BGMS. Up to 15 minutes
Primary Instructions for Use Evaluation questionnaire. Questionnaires to assess the effectiveness of the instructions for use. Up to 10 days.
Primary Marketing Claims Evaluation questionnaire. Assess Lay User Acceptance of the Frazier 3 BGMSs in support of marketing claims. Up to 10 days
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