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

Not Applicable

Completed

Interventions: Device: DIDGET (Investigational Blood Glucose Monitoring System)

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Subjects with diabetes	DIDGET (Investigational Blood Glucose Monitoring System)	Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.

Primary Outcome Measures

Name	Time	Method
Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method	1-2 hours	Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG values \>/=75mg/dL) of the reference method results.

Secondary Outcome Measures