Status:
COMPLETED
User Study of an Investigational Blood Glucose Monitoring System
Lead Sponsor:
Ascensia Diabetes Care
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.
Eligibility Criteria
Inclusion
- Type 1 or type 2 diabetes
- 18 years of age and older
- Able to speak, read, and understand English
- Willing to complete all study procedures
Exclusion
- Previously participated in a study using this investigational system
- Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
- Pregnancy
- Hemophilia or any other bleeding disorder
- 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
- 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).
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01447121
Start Date
September 1 2011
End Date
September 1 2011
Last Update
February 29 2016
Active Locations (1)
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1
AMCR Institute
Escondido, California, United States, 92026