Evaluation of a Diabetes Data Management System

Diabetes Clinical Trial

Official title:

Evaluation of a Diabetes Data Management System In a Clinical Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694070
• Other study ID #: CTD-2008-11
• Status: Completed
• Phase: N/A
• First received: June 6, 2008
• Last updated: January 29, 2016
• Start date: July 2008
• Est. completion date: July 2008

Study information

• Verified date: January 2016
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
United States	AMCR Institute	Escondido	California

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)	After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5.; Very Simple; Simple; Neither simple nor difficult; Difficult; Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3.	1-2 hours	No
Primary	Number of Participants Rated as <= 3 (Success in Using the Program)	Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was: successful; 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.	1-2 hours	No
Primary	Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)	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	No