Evaluation of GLUCOFACTS® Deluxe Diabetes 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: NCT00892151
Recruitment Status : Completed
First Posted : May 4, 2009
Results First Posted : May 18, 2010
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 management program in the hands of potential users, both health care professionals and lay persons.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: GLUCOFACTS® Deluxe Not Applicable

Detailed Description:
Diabetes data management programs upload glucose meter results to computers to provide information at home to lay people with diabetes and their healthcare professionals to manage their diabetes. The study evaluated the subjects' success using the software program with a blood glucose meter to perform specific tasks, such as uploading the meter results, changing program and meter settings, and displaying reports. The study also evaluated the system's ease of use and the acceptability of product labeling.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of GLUCOFACTS® Deluxe Diabetes Management System In a Clinical Setting
Study Start Date : April 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: Intended Users of the Software
10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) using a diabetes data management program.
Device: GLUCOFACTS® Deluxe
Diabetes Data Management Software

Primary Outcome Measures :
  1. Number of Participants Rated Successful (<=3) at Performing Specific Tasks [ Time Frame: 1-2 hours ]

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

    1. = Successful
    2. = Successful after being referred to user instructions
    3. = Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)
    4. = Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)
    5. = Problem encountered with software

Secondary Outcome Measures :
  1. Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 [ Time Frame: 1-2 hours ]

    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

  2. Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3 [ Time Frame: 1-2 hours ]

    User instructions included online help, User Guide, and a Quick Reference Guide. Subjects rated their clarity and usefulness and the rating scale was:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Lay users must:

  • Be at least 18 years of age (at least 80% must be 55 years or less)
  • Have diabetes or be the parent or legal guardian of a child with diabetes who routinely test their blood sugar at home
  • 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 PC programs or browsing the internet
  • Have utilized diabetes management software at home in the last year (at least 75% of lay users) or be familiar with diabetes management software

HCPs must:

  • Have experience using diabetes data management software in the medical office or assist in patients' diabetes disease management using software

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.

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): NCT00892151

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: NCT00892151     History of Changes
Other Study ID Numbers: CTD-2009-01
First Posted: May 4, 2009    Key Record Dates
Results First Posted: May 18, 2010
Last Update Posted: February 29, 2016
Last Verified: January 2016

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