Status:
COMPLETED
Performance of a New Glucose Meter System in Children and Young Adults
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 of a new blood glucose meter in the hands of children, teens, young adults.
Eligibility Criteria
Inclusion
- Type 1 or Type 2 diabetes
- Age 4 to 24 years
- Routinely performs blood glucose testing at home
- If age 18 or older at time informed consent is signed, subject must be able to speak, read, and understand English.
- If younger than age 18, subject's parent/guardian must be able to speak, read, and understand English, and is able to provide appropriate supervision.
- Is willing to complete all study procedures, with or without parent / guardian supervision, if appropriate
Exclusion
- Currently pregnant
- 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 :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00985257
Start Date
September 1 2009
End Date
October 1 2009
Last Update
February 29 2016
Active Locations (2)
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1
AMCR Institute
Escondido, California, United States, 92026
2
Larry C. Deeb, MD PA
Tallahassee, Florida, United States, 32308