Evaluation of a Diabetes Data Management System - Full Text View

Sponsored by:	Bayer HealthCare, Diabetes Care
Information provided by:	Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:	NCT00694070

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 Mellitus

MedlinePlus related topics: Diabetes

U.S. FDA Resources

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

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

Primary Outcome Measures:

Ease of use of the software program [ Time Frame: 1 visit ] [ Designated as safety issue: No ]
Success in using the program [ Time Frame: 1 visit ] [ Designated as safety issue: No ]
Comprehension of the program reports [ Time Frame: 1 visit ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
h,p h = health care professional p = lay user

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

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

Responsible Party:	Bayer Diabetes Care ( Joan Lee Parkes, PhD, CCRA/Director, Clinical Trials Division )
Study ID Numbers:	CTD-2008-11
Study First Received:	June 6, 2008
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00694070
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009