User Performance Evaluation of an Investigational Blood Glucose Monitoring System

Ninja 2 User Performance Evaluation

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 .

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