Evaluation of GLUCOFACTS® Deluxe Diabetes Management System

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a Diabetes management program in the hands of potential users, both health care professionals and lay persons.

Detailed Description
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Diabetes data management programs upload glucose meter results to computers to provide information at home to lay people with diabetes and their healthcare professionals to manage their diabetes. The study evaluated the subjects' success using the software program with a blood glucose meter to perform specific tasks, such as uploading the meter results, changing program and meter settings, and displaying reports. The study also evaluated the system's ease of use and the acceptability of product labeling.

Official Title
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Evaluation of GLUCOFACTS® Deluxe Diabetes Management System In a Clinical Setting

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: GLUCOFACTS® Deluxe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lay users must: Be at least 18 years of age (at least 80% must be 55 years or less) Have diabetes or be the parent or legal guardian of a child with diabetes who routinely test their blood sugar at home Be testing blood sugar at home at least twice daily for at least one month or be the parent or legal guardian of a child who has been testing blood sugar at home at least twice daily for at least one month Be able to speak, read, and understand English Have experience using PC programs or browsing the internet Have utilized diabetes management software at home in the last year (at least 75% of lay users) or be familiar with diabetes management software HCPs must: Have experience using diabetes data management software in the medical office or assist in patients' diabetes disease management using software Exclusion Criteria: Person working for a competitive medical device company Person having a cognitive disorder or condition which, in the opinion of the investigator, would put the person at risk or compromise the integrity of the study.

Ages Eligible for Study
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Minimum Age: 18 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 Software<br>10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) using a diabetes data management program. | Device: GLUCOFACTS® Deluxe<br>* Diabetes Data Management Software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Rated Successful (<=3) at Performing Specific Tasks | Study staff rated participants on their success at perfoming specific tasks. The rating scale was: = Successful = Successful after being referred to user instructions = Successful with 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.) = Problem encountered with software | 1-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 | Subjects rated ease of using the software with respect to specific tasks. The rating scale was: = Very Simple = Simple = Neither Simple nor Difficult = Difficult = Very Difficult | 1-2 hours | 
| Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3 | User instructions included online help, User Guide, and a Quick Reference Guide. Subjects rated their clarity and usefulness and the rating scale was: = Unacceptable = Poor = Good = Very Good = Excellent | 1-2 hours |