Project Frazier 3 Regulatory Clinical Evaluation

LifeScan

Status: Completed

Conditions: Healthy Volunteers; Diabetes Mellitus

Treatments: Device: Frazier 3 Verio; Device: Frazier 3 UltraPlus

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03515421

3165622

Details and patient eligibility

About

Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

Full description

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

Enrollment: 379 patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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379 participants in 1 patient group

Blood Glucose monitoring System (BGMS)

Experimental group

Description:

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)

Treatment:

Device: Frazier 3 Verio

Device: Frazier 3 UltraPlus