Project Frazier 3 Regulatory Clinical Evaluation

Study Overview
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Brief Summary
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Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

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.

Official Title
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Project Frazier 3 Regulatory Clinical Evaluation

Conditions
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Diabetes Mellitus, Healthy Volunteers

Intervention / Treatment
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* Device: Frazier 3 Verio
* Device: Frazier 3 UltraPlus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood Glucose monitoring System (BGMS)<br>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<br>* In vitro diagnostic device (IVDD)<br>Device: Frazier 3 UltraPlus<br>* In vitro diagnostic device (IVDD)<br>|

What is the study measuring?
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Primary Outcome Measures

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