Evaluation of GLUCOFACTS® Deluxe Diabetes Management System

Diabetes Mellitus Clinical Trial

Official title:

Evaluation of GLUCOFACTS® Deluxe Diabetes Management System In a Clinical Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892151
• Other study ID #: CTD-2009-01
• Status: Completed
• Phase: N/A
• First received: May 1, 2009
• Last updated: January 29, 2016
• Start date: April 2009
• Est. completion date: April 2009

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: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• GLUCOFACTS® Deluxe
Diabetes Data Management Software

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 Rated Successful (<=3) at Performing Specific Tasks	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	1-2 hours	No
Secondary	Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3	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	1-2 hours	No
Secondary	Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3	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	1-2 hours	No