- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00694070
Evaluation of a Diabetes Data Management System
January 29, 2016 updated by: Ascensia Diabetes Care
Evaluation of a Diabetes Data Management System In a Clinical Setting
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
51
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Escondido, California, United States, 92026
- AMCR Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Lay users males or females and health care professionals.
Description
Inclusion Criteria:
Health Care Professionals:
- 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.
- May include: endocrinologists, primary care physicians, nurse educators, or other medical staff involved in downloading meters or interpreting the data output.
Lay users must:
- Be at least 18 years of age.
- 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.
- Be able to speak, read and understand English.
- 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.
- Have experience using PC programs or browsing the internet.
Exclusion Criteria:
- Persons working for a competitive medical device company.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
health care professionals and lay users
h= 8 health care professionals p= 43 lay users
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5.
|
1-2 hours
|
Number of Participants Rated as <= 3 (Success in Using the Program)
Time Frame: 1-2 hours
|
Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was:
|
1-2 hours
|
Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)
Time Frame: 1-2 hours
|
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.
|
1-2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
June 6, 2008
First Submitted That Met QC Criteria
June 6, 2008
First Posted (Estimate)
June 10, 2008
Study Record Updates
Last Update Posted (Estimate)
February 29, 2016
Last Update Submitted That Met QC Criteria
January 29, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTD-2008-11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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