User Study of an Investigational Blood Glucose Monitoring System

Study Overview
=================
Brief Summary
-----------------
This clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.

Official Title
-----------------
Tatsu/Tradewind System User Performance Evaluation

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: Tatsu/Tradewind Investigational BG Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 or type 2 diabetes 18 years of age and older Able to speak, read, and understand English Willing to complete all study procedures Exclusion Criteria: Previously participated in a study using this investigational system Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors Pregnancy Hemophilia or any other bleeding disorder 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 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick. | Device: Tatsu/Tradewind Investigational BG Monitoring System<br>* Tradewind is a Bayer investigational meter that used an investigational sensor.<br>|

What is the study measuring?
-----------------
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 tested self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasm BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15 mg/dL (for reference BG results <75mg/dL) or +/- 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 Study Staff Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method When Testing Subject Blood Glucose (BG) | Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were 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 reference method results. | 1 hour |