Status:
COMPLETED
User Performance Evaluation of an Investigational Blood Glucose Monitoring System
Lead Sponsor:
Ascensia Diabetes Care
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01410773
Start Date
July 1 2011
End Date
August 1 2011
Last Update
February 29 2016
Active Locations (1)
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1
Bayer HealthCare LLC, Diabetes Care
Mishawaka, Indiana, United States, 46544