Evaluation of a Diabetes Data Management System
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 Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Evaluation of a Diabetes Data Management System In a Clinical Setting|
- 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 ] [ Designated as safety issue: No ]
After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5.
- Very Simple
- Neither simple nor difficult
- Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3.
- Number of Participants Rated as <= 3 (Success in Using the Program) [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]
Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was:
- successful after being referred to user instructions
- success with assistance (similar to a customer call)
- unsuccessful 5 = software problem Outcome measure was the number of participants rated as <= 3.
- Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports) [ Time Frame: 1-2 hours ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2008|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
health care professionals and lay users
h= 8 health care professionals p= 43 lay users
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694070
|United States, California|
|Escondido, California, United States, 92026|
|Principal Investigator:||Timothy Bailey, MD||AMCR Institute|