User Performance Evaluation of an Investigational Blood Glucose Monitoring System

Completed · Not applicable

Conditions studied: Diabetes

In brief

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 .

Key facts

Study ID

NCT01410773

Run by

Ascensia Diabetes Care

People needed

110

Starts

2011-07-01

Expected to finish

2011-08-01

Last updated by the study team

2016-02-29

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 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

You may not qualify if…

• 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

Where it is running

• Bayer HealthCare LLC, Diabetes Care — Mishawaka, Indiana, United States

Full record on ClinicalTrials.gov

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