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

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

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

Conditions
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Diabetes

Intervention / Treatment
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* Device: Investigational Blood Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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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

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 |
| --- | --- |
| Experimental: Intended Users of the Monitoring System<br>Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable. | Device: Investigational Blood Glucose Monitoring System<br>* Subjects with diabetes used a new blood glucose monitoring system with capillary blood. Certain results were compared to a laboratory glucose method.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method | Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values <75mg/dL) or +/- 20% (for reference blood glucose values >/= 75mg/dL)of the reference results were calculated. | 1-2 hours | 
| Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results | Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values <75mg/dL) and within +/- 20% (for reference BG values >= 75mg/dL)of the HCP results was calculated. | 1-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies | The Parkes Error Grid, developed from a survey of 100 clinicians, plots combinations of BG meter measurements against reference method results. Each (x,y) point on the grid is within a risk category, assigned by the clinicians surveyed. Risk categories (increasing severity): ZoneA: No effect on clinical action; ZoneB: Altered clinical action or little/no effect on clinical outcome; ZoneC: Altered clinical action likely to effect clinical outcome; ZoneD: Altered clinical action could have significant medical risk; ZoneE: Altered clinical action could have dangerous consequences | 1-2 hours | 
| Number of Participants Rated as <=2 (Labeling Comprehension) | Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows: Successful in performing tasks correctly without assistance Successful after study staff prompted participant to review User Guide. Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.) Subject did not perform task correctly and study staff intervention was required. | 1-2 hours | 
| Average Within Replicate Coefficient of Variation CV (Precision) | The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root. | 1-2 hours |