Evaluation of GLUCOFACTS® Deluxe Diabetes Management System

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Intended Users of the Software	GLUCOFACTS® Deluxe	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Rated Successful (<=3) at Performing Specific Tasks	1-2 hours	Study staff rated participants on their success at perfoming specific tasks. The rating scale was: 1. = Successful 2. = Successful after being referred to user instructions 3. = Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) 4. = Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.) 5. = Problem encountered with software

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3	1-2 hours	Subjects rated ease of using the software with respect to specific tasks. The rating scale was: 1. = Very Simple 2. = Simple 3. = Neither Simple nor Difficult 4. = Difficult 5. = Very Difficult
Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3	1-2 hours	User instructions included online help, User Guide, and a Quick Reference Guide. Subjects rated their clarity and usefulness and the rating scale was: 1. = Unacceptable 2. = Poor 3. = Good 4. = Very Good 5. = Excellent