Evaluation of a Diabetes Data Management System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00694070
First received: June 6, 2008
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 health care professionals and lay users.


Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluation of a Diabetes Data Management System In a Clinical Setting

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.

  • Number of Participants Rated as <= 3 (Success in Using the Program) [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]

    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.

  • Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports) [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 51
Study Start Date: July 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
health care professionals and lay users
h= 8 health care professionals p= 43 lay users

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Lay users males or females and health care professionals.

Criteria

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.
  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: NCT00694070

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: NCT00694070     History of Changes
Other Study ID Numbers: CTD-2008-11
Study First Received: June 6, 2008
Results First Received: July 1, 2009
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 16, 2014