In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System

Completed · Not applicable

Conditions studied: Diabetes

In brief

The purpose of this study is to evaluate the performance and acceptability of a new blood glucose meter.

Key facts

Study ID

NCT00803777

Run by

Ascensia Diabetes Care

People needed

147

Starts

2008-12-01

Expected to finish

2009-03-01

Last updated by the study team

2016-02-29

Who can join

Age: 4 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AMCR Institute — Escondido, California, United States
• Childrens Hospital Los Angeles — Los Angeles, California, United States
• Barbara Davis Center — Aurora, Colorado, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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