Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter System

Study Overview
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Brief Summary
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The purpose of the study was to evaluate the acceptability of product user guides for untrained subjects and to evaluate the performance of the system with lay users and healthcare providers (HCPs).

Detailed Description
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The study evaluated the acceptability of product labeling for performing blood glucose testing with the new blood glucose meter system (BGMS) and for using meter features. Sections of the User Guide and Quick Reference Guide that gave instruction on performing a blood glucose test and operating system features were evaluated, including instructions on connectivity of the system with a computer, meter setup, glucose trends display, and other system features. The study also evaluated the performance of the blood glucose meter system (BGMS) in the hands of subjects and healthcare professionals using capillary blood. Subjects and healthcare professionals provided feedback about the BGMS and its features. Some subjects took the system home to evaluate the robustness of the BGMS.

Official Title
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Labeling Comprehension and Performance Evaluation of the Apollo Blood Glucose Monitoring System With Capillary Blood [Commercial Name is CONTOUR® USB]

Conditions
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Diabetes

Intervention / Treatment
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* Device: Apollo Blood Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have type 1 or type 2 diabetes Be at least 18 years of age but have not reached their 76th birthday, with approximately 50% (+10%) being less than 55 years of age, at time of consent Be willing to complete all study procedures Be routinely testing their blood sugar at home (at least once per day) Be able to speak, read, and understand English and understand the Informed Consent document Be able to read the labeling instructions Own or operate a computer for personal or professional use beyond that for email correspondence. Subjects will not have to use their personal computer for the study, but computer use will be required. Exclusion Criteria: Minors <18 years of age and adults >75 years of age Pregnancy Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS Disorders in the fingertip lancing areas Acute or chronic infections, particularly skin infections Infection with a blood borne pathogen Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81mg or 325 mg) is not reason for exclusion Hemophilia or any other bleeding disorder Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study Working for a competitive medical device company

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 use a new blood glucose monitoring system with subject capillary blood. | Device: Apollo Blood Glucose Monitoring System<br>* Subjects with diabetes were rated for success in performing tasks with a new blood glucose monitoring system (BGMS). Also, subjects and healthcare professionals (HCPs) used the new blood glucose monitoring system with subject capillary blood. All blood glucose results were compared to a laboratory glucose method - Yellow Springs Instrument(YSI) Analyzer.<br>* Other names: Commercial name is CONTOUR® USB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Rated as <=3 (Comprehension of Labeling) | Study staff rated participants on their success at performing Blood Glucose (BG) testing and other system features after subjects read product labeling. The rating scale was: Successful in performing tasks correctly without assistance Successful after being referred to user instructions Successful after verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.) | 1-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Capillary Blood 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 capillary blood. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods; this study evaluated results equivalent to plasma lab methods. All results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects using three lots of Contour Blood Glucose strips, evenly distributed among the subjects. | 1-2 hours |