User Study of an Investigational Blood Glucose Monitoring System

Tatsu/Tradewind System User Performance Evaluation

This clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.

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).