Study of an Investigational Glucose Meter System

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Official Title
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Performance of the G3 Blood Glucose Monitoring System With TATSU Strip

Conditions
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Diabetes

Intervention / Treatment
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* Device: G3 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 older Type 1 or type 2 diabetes Able to speak, read, and understand English Willing to complete all study procedures Exclusion Criteria: Pregnancy Hemophilia or any other bleeding disorder Previously participated in a study using the G3 system Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors. A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee). Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.

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 Monitoring System<br>Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. | Device: G3 Investigational Blood Glucose Monitoring System<br>* Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with 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 +/- 5to15mg/dL (<100mg/dL YSI capillary plasma) or +/- 5to15% (>=100mg/dL YSI capillary plasma). Site staff tested in parallel after subjects. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma). | 1 hour | 
| Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method | Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI venous plasma results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<75mg/dL YSI venous plasma) or +/- 5to20% (>=75mg/dL YSI venous plasma). | 1 hour | 
| Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction | After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to utilize some of the additional features of the system. Study staff documents Yes or No 'Did the subject complete the task successfully?' | 1 hour |