Evaluation of GLUCOFACTS® Deluxe Diabetes Management System
This study has been completed.
Sponsor:
Bayer HealthCare, Diabetes Care
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
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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:
- = Successful
- = Successful after being referred to user instructions
- = Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)
- = Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)
- = 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:
- = Very Simple
- = Simple
- = Neither Simple nor Difficult
- = Difficult
- = 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:
- = Unacceptable
- = Poor
- = Good
- = Very Good
- = 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
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 May 19, 2013