Evaluation of DIDGET TM World Reports

Diabetes Clinical Trial

Official title:

Evaluation of Avatar Web Reports

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00923975
• Other study ID #: CTD-2009-08
• Status: Completed
• Phase: N/A
• First received: June 17, 2009
• Last updated: January 29, 2016
• Start date: June 2009
• Est. completion date: June 2009

Study information

• Verified date: January 2016
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Lay users must be:

1. Be at least 18 years of age

2. Have diabetes or be the parent or legal guardian of a child with diabetes

3. 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

4. Be able to speak, read, and understand English

5. Have experience using a PC, navigating software programs, or browsing the internet

• Healthcare professionals must:

1. Have experience using the internet

2. Have experience using diabetes data management software in the medical office

Exclusion Criteria:

1. Person working for a competitive medical device company

2. 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• DIDGET World Web Community Reports
During the study subjects performed specific tasks, such as uploading meter results to a secure website and displaying reports.

Locations

Country	Name	City	State
United States	AMCR Institute	Escondido	California

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No