Performance of a New Glucose Meter System in Children and Young Adults

Performance of the DIDGET Blood Glucose Monitoring System in Children and Young Adults

The purpose of this study is to evaluate the performance of a new blood glucose meter in the hands of children, teens, young adults.

Inclusion Criteria:

• 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 Criteria:

• 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