Evaluation of a Diabetes Data Management System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00694070
Recruitment Status : Completed
First Posted : June 10, 2008
Results First Posted : September 23, 2009
Last Update Posted : February 29, 2016
Information provided by (Responsible Party):
Ascensia Diabetes Care

Brief Summary:
The purpose of this study is to evaluate a diabetes data management program in the hands of potential users, both health care professionals and lay users.

Condition or disease

Detailed Description:
Diabetes data management programs analyze blood glucose results downloaded from glucose meters to assist health care professionals or lay users manage their diabetes. During the study, subjects download meters, generate and print reports, evaluate the program's ease of use, and verify that they understand the program output.

Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of a Diabetes Data Management System In a Clinical Setting
Study Start Date : July 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

health care professionals and lay users
h= 8 health care professionals p= 43 lay users

Primary Outcome Measures :
  1. Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program) [ Time Frame: 1-2 hours ]

    After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5.

    1. Very Simple
    2. Simple
    3. Neither simple nor difficult
    4. Difficult
    5. Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3.

  2. Number of Participants Rated as <= 3 (Success in Using the Program) [ Time Frame: 1-2 hours ]

    Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was:

    1. successful
    2. successful after being referred to user instructions
    3. success with assistance (similar to a customer call)
    4. unsuccessful 5 = software problem Outcome measure was the number of participants rated as <= 3.

  3. Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports) [ Time Frame: 1-2 hours ]
    Subjects were asked thirty questions throughout the evaluation to test whether they understood the data displays, graphs and features of the software. Outcome measure was the number of participants that could answer at least 85% of the comprehension questions correctly.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Lay users males or females and health care professionals.

Inclusion Criteria:

  • Health Care Professionals:

    1. Must have experience using diabetes data management software in the medical office such as downloading meters, reviewing reports (computer screen or printouts), or assisting in patients' diabetes disease management using software.
    2. May include: endocrinologists, primary care physicians, nurse educators, or other medical staff involved in downloading meters or interpreting the data output.
  • Lay users must:

    1. Be at least 18 years of age.
    2. Have diabetes (or be the parent or legal guardian of a child with diabetes) and have been testing blood sugar at home at least twice daily for one month or more.
    3. Be able to speak, read and understand English.
    4. Currently using diabetes management software at home or be familiar with diabetes management software. At least 75% of subjects must have been using software for at least one month.
    5. Have experience using PC programs or browsing the internet.

Exclusion Criteria:

  • Persons working for a competitive medical device company.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00694070

United States, California
AMCR Institute
Escondido, California, United States, 92026
Sponsors and Collaborators
Ascensia Diabetes Care
Principal Investigator: Timothy Bailey, MD AMCR Institute

Responsible Party: Ascensia Diabetes Care Identifier: NCT00694070     History of Changes
Other Study ID Numbers: CTD-2008-11
First Posted: June 10, 2008    Key Record Dates
Results First Posted: September 23, 2009
Last Update Posted: February 29, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases