Status:
COMPLETED
Performance 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 was 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 or older.
- People with type 1 or type 2 diabetes.
- Able to speak, read and understand English.
- Willing to complete all study procedures.
Exclusion
- Hemophilia or any other bleeding disorder.
- Pregnancy.
- Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM.
- Previously participated in a blood glucose monitoring study using the Ninja 3 Plus BGMS.
- Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose meters.
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01824355
Start Date
March 1 2013
End Date
March 1 2013
Last Update
February 29 2016
Active Locations (1)
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1
Consumer Product Testing Co.
Fairfield, New Jersey, United States, 07004