Evaluation of an Ascensia Lancing System

Completed · Not applicable

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT02606838

Run by

Ascensia Diabetes Care

People needed

119

Starts

2015-11-01

Expected to finish

2015-12-01

Last updated by the study team

2017-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ascensia Diabetes Care — Mishawaka, Indiana, United States

Full record on ClinicalTrials.gov

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