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

In-Clinic and Home-Use Study of the AVATAR Blood Glucose Monitoring System in Children and Young Adults

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

Inclusion Criteria:

• 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 Criteria:

• 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