Evaluation of DIDGET TM World Reports

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a Diabetes data management program in the hands of potential users, both lay persons and healthcare professionals. With this data management system glucose results from the DIDGET TM meter can be uploaded to a secure website and used by adults with diabetes, by parents and guardians of children with diabetes, and by health care professionals to monitor diabetes by recognizing trends and patterns in blood sugar levels.

Detailed Description
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Diabetes data management programs upload glucose meter results to computers to provide information to lay persons and their health care professionals. With this data management system glucose results from the DIDGET TM meter can be uploaded to a secure website and used by adults with diabetes, by parents and guardians of children with diabetes, and by health care professionals to monitor diabetes by recognizing trends and patterns in blood sugar levels. During the study subjects performed specific tasks, such as uploading meter results and displaying reports. The study evaluates the subjects' success in using the software program, the program's ease of use, clarity and usefulness of user instructions, and user satisfaction with the diabetes data management program.

Official Title
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Evaluation of Avatar Web Reports

Conditions
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Diabetes

Intervention / Treatment
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* Device: DIDGET World Web Community Reports


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lay users must be: Be at least 18 years of age Have diabetes or be the parent or legal guardian of a child with diabetes 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 a PC, navigating software programs, or browsing the internet Healthcare professionals must: Have experience using the internet Have experience using diabetes data management software in the medical office 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 |
| --- | --- |
| Other: Intended Users of the Software<br>Young adults, parents/guardians of young people under age 18, and healthcare professionals who work with this population would be intended users of the data management program. The DIDGET World Reports software is used to upload blood glucose results from the DIDGET Blood Glucose Monitoring System so that intended users can identify patterns in their diabetes management. | Device: DIDGET World Web Community Reports<br>* During the study subjects performed specific tasks, such as uploading meter results to a secure website and displaying reports.<br>* Other names: DIDGET World Web Community;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Out of 50 Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks | Study staff rated participants on their success at performing specific tasks. The rating scale was: = Successful ( no assistance) = Successful after staff prompted to view user instructions = Successful with verbal assistance or review of part of user instructions (as review a specific function during a Customer Service call) = Unsuccessful (Subject could not perform the task) = Subject could not perform task due to software or hardware failure after repeated attempt. | 1-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Out of 50 Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) | 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 Good to Excellent (>=3) | After the software evaluation, subjects were asked to review the online help and rate it on a 5 point scale. = Unacceptable = Poor = Good = Very Good = Excellent | 1-2 hours | 
| Number of Participants Out of 50 Who Rated Their Satisfaction With The Following as Good to Excellent (>=3) | Subjects responded to questionnaires in rating features and appearance, usefulness, and satisfaction on a 5 point scale: = Unacceptable = Poor = Good = Very Good = Excellent | 1-2 hours |