Status:
COMPLETED
In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System
Lead Sponsor:
Ascensia Diabetes Care
Conditions:
Diabetes
Eligibility:
All Genders
4-24 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the performance and acceptability of a new blood glucose meter.
Eligibility Criteria
Inclusion
- Type 1 diabetes
- Age 4 to 24 years
- Routinely performs blood glucose testing at home, at least 2 times per day, for one month or more before enrollment
- Has used a handheld game system to play video games within a year of enrollment
- If above age 18, subject is able to speak, read, and understand English. If below age 18, subject's parent/guardian is able to speak, read, and understand English, and is able to provide appropriate supervision.
- Is willing to complete all study procedures, with appropriate parent/guardian supervision
Exclusion
- Hemophilia or any other bleeding disorder
- Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded
- Infection with a blood borne pathogen (e.g., HIV, hepatitis)
- Subject or parent/guardian is employee of competitive medical device company
- Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00803777
Start Date
December 1 2008
End Date
March 1 2009
Last Update
February 29 2016
Active Locations (4)
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1
AMCR Institute
Escondido, California, United States, 92026
2
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
3
Barbara Davis Center
Aurora, Colorado, United States, 80045
4
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601