Evaluation of GLUCOFACTS® Deluxe Diabetes Management System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT00892151
First received: May 1, 2009
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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 Intervention
Diabetes Mellitus
Device: GLUCOFACTS® Deluxe

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of GLUCOFACTS® Deluxe Diabetes 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 Rated Successful (<=3) at Performing Specific Tasks [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]

    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:
  • Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3 [ 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 >=3 [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]

    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


Enrollment: 51
Study Start Date: April 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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 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.
  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: NCT00892151

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: NCT00892151     History of Changes
Other Study ID Numbers: CTD-2009-01
Study First Received: May 1, 2009
Results First Received: April 15, 2010
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 September 30, 2014