User Performance Evaluation of an Investigational Blood Glucose Monitoring System

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that untrained subjects with diabetes can use an investigational Blood Glucose Monitoring System (BGMS) with capillary blood obtained from fingerstick and from Alternative Site (AST) Palm .

Official Title
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Ninja 2 User Performance Evaluation

Conditions
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Diabetes

Intervention / Treatment
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* Device: Ninja 2 Investigational Blood Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, 18 years of age and above Diagnosed as having type 1 or type 2 diabetes Currently self-testing blood glucose at home Able to speak, read, and understand English Willing to complete all study procedures Exclusion Criteria: Blood Borne infections like hepatitis or HIV or infections such as tuberculosis Hemophilia or any other bleeding disorder Employee of competitive medical device company,immediate family member of such, or living within the household of such Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intended Users of the System<br>Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm. | Device: Ninja 2 Investigational Blood Glucose Monitoring System<br>* The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Meter (BGM). BGM results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or within +/- 20%(for reference BG results >=75mg/dL) of the reference method results (YSI capillary plasma). | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test subject Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGM meter results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the YSI capillary plasma reference method results. | 1 hour |