Status:
COMPLETED
Study of an Investigational Glucose Meter 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 who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
Eligibility Criteria
Inclusion
- Males and females, 18 years of age and older
- Type 1 or type 2 diabetes
- Able to speak, read, and understand English
- Willing to complete all study procedures
Exclusion
- Pregnancy
- Hemophilia or any other bleeding disorder
- Previously participated in a study using the G3 system
- Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
- A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
- Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT01474317
Start Date
November 1 2011
End Date
November 1 2011
Last Update
February 29 2016
Active Locations (2)
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1
Consumer Product Testing Co.
Fairfield, New Jersey, United States, 07004
2
Southwest Clinical Research Center
Santa Fe, New Mexico, United States, 87505