Status:
COMPLETED
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 was to determine if 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
- 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 BG monitor study using the Ninja 3 BGMS
- Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
- 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.
- The enrollment criteria for the study population:
- At least 60% of subjects will be younger than age 65
- At least 20% of subjects will have type 1 diabetes
- At least 50% of subjects with type 2 diabetes wil be insulin users.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT01859494
Start Date
April 1 2013
End Date
May 1 2013
Last Update
February 10 2017
Active Locations (2)
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1
AMCR Institute
Escondido, California, United States, 92026
2
Rainier Clinical Research Center
Renton, Washington, United States, 98057