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OpenTrials
Completed

NCT Number: NCT00923975

Evaluation of DIDGET TM World Reports

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AMCR Institute

Escondido, California, 92026, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DIDGET World Web Community Reports

Device

During the study subjects performed specific tasks, such as uploading meter results to a secure website and displaying reports.

Other names: DIDGET World Web Community

Primary outcomes

  1. Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks

    Time frame: 1-2 hours

    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.

Secondary outcomes

  1. Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating)

    Time frame: 1-2 hours

    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

  2. Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)

    Time frame: 1-2 hours

    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

  3. Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)

    Time frame: 1-2 hours

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

    • = Unacceptable
    • = Poor
    • = Good
    • = Very Good
    • = Excellent

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Official study title

Evaluation of Avatar Web Reports

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jun 18, 2009
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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