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

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

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

Conditions
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Diabetes

Intervention / Treatment
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* Device: DIDGET (Investigational Blood Glucose Monitoring System)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subjects with diabetes<br>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. | Device: DIDGET (Investigational Blood Glucose Monitoring System)<br>* Subjects with diabetes (with parent/guardian assistance, if applicable)and health care professionals (HCPs) each performed duplicate Blood Glucose (BG) tests from the subject's capillary blood on the DIDGET. To test the full range of glucose concentrations, a venipuncture was performed on some subjects to obtain enough blood for modifying (spiking or glycolyzing) to the extreme glucose concentrations. Results were compared to a laboratory glucose method - the Yellow Springs Instrument (YSI) Analyzer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method | 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. | 1-2 hours |