Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System

Study Overview
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Brief Summary
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The purpose of this study is to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid glucose results.

Official Title
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User Performance of the Karajishi Contour Blood Glucose Monitoring System

Conditions
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Diabetes

Intervention / Treatment
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* Device: Karajishi Contour Investigational BG Monitoring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, 18 years of age and older People with type 1 or type 2 diabetes Able to speak, read, and understand English Willing to complete all study procedures Exclusion Criteria: Hemophilia or any other bleeding disorder Pregnancy Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM Previously participated in a BG monitor study using the Karajishi BGMS (or used a Bayer Contour meter) Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors Working for a competitive medical device company, or having an immediate family member who works for such a company A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intended Users of the Monitoring System<br>Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population: At least 60% of subjects will be younger than age 65 At least 10% of subjects will have type 1 diabetes | Device: Karajishi Contour Investigational BG Monitoring System<br>* Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.<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 +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method | Subjects with diabetes self-test fingerstick blood use an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma). | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method | Study staff test subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma). | 1 hour | 
| Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method | Subjects with diabetes self-test Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma). | 1 hour | 
| Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff | Study staff obtain and test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma). | 1 hour | 
| Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements | Staff will obtain subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects may respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree. | 1 hour |