Evaluation of DIDGET TM World Reports

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00923975
First received: June 17, 2009
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Diabetes
Device: DIDGET World Web Community Reports

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Avatar Web Reports

Resource links provided by NLM:


Further study details as provided by Bayer HealthCare, Diabetes Care:

Primary Outcome Measures:
  • Number of Participants Out of 50 Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]

    Study staff rated participants on their success at performing specific tasks. The rating scale was:

    1. = Successful ( no assistance)
    2. = Successful after staff prompted to view user instructions
    3. = Successful with verbal assistance or review of part of user instructions (as review a specific function during a Customer Service call)
    4. = Unsuccessful (Subject could not perform the task)
    5. = Subject could not perform task due to software or hardware failure after repeated attempt.


Secondary Outcome Measures:
  • Number of Participants Out of 50 Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating) [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]

    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 Good to Excellent (>=3) [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]

    After the software evaluation, subjects were asked to review the online help and rate it on a 5 point scale.

    1. = Unacceptable
    2. = Poor
    3. = Good
    4. = Very Good
    5. = Excellent

  • Number of Participants Out of 50 Who Rated Their Satisfaction With The Following as Good to Excellent (>=3) [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]

    Subjects responded to questionnaires in rating features and appearance, usefulness, and satisfaction on a 5 point scale:

    1. = Unacceptable
    2. = Poor
    3. = Good
    4. = Very Good
    5. = Excellent


Enrollment: 51
Study Start Date: June 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intended Users of the Software
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
During the study subjects performed specific tasks, such as uploading meter results to a secure website and displaying reports.
Other Name: DIDGET World Web Community

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923975

Locations
United States, California
AMCR Institute
Escondido, California, United States, 92026
Sponsors and Collaborators
Bayer HealthCare, Diabetes Care
Investigators
Principal Investigator: Timothy Bailey, MD AMCR Institute
  More Information

No publications provided

Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT00923975     History of Changes
Other Study ID Numbers: CTD-2009-08
Study First Received: June 17, 2009
Results First Received: June 10, 2010
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 20, 2014