Evaluation of an Ascensia Lancing System

User Performance of the Styx Lancing System

The purpose of this study was to determine if untrained subjects with diabetes could perform basic tasks with the Styx lancing device to obtain adequate blood volume from fingerstick and palm lancings for Blood Glucose Meter testing.

Inclusion Criteria:

• Males and females, 18 years of age and older
• People with type 1 or type 2 diabetes
• People who regularly perform self-tests (at least once/day) with their own lancing device
• Able to speak, read, and understand English
• Willing to complete all study procedures

Exclusion Criteria:

• Those with missing tips of the fingers indicated in the protocol or physically unable to lance the palm areas and all the fingers indicated in the protocol.
• Hemophilia or any other bleeding disorder
• Pregnancy
• Physical, visual or neurological impairments that would make the person unable to perform testing
• Persons who have used the Styx device in a previous clinical evaluation
• 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