Project Frazier 3 Regulatory Clinical Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

379 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-09

Study Completion Date

2018-06-18

Brief Summary

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Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

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Detailed Description

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

Conditions

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Diabetes Mellitus Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Frazier 3 Verio

Intervention Type DEVICE

In vitro diagnostic device (IVDD)

Frazier 3 UltraPlus

Intervention Type DEVICE

In vitro diagnostic device (IVDD)

Interventions

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Frazier 3 Verio

In vitro diagnostic device (IVDD)

Intervention Type DEVICE

Frazier 3 UltraPlus

In vitro diagnostic device (IVDD)

Intervention Type DEVICE

Eligibility Criteria

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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