Evaluation of GLUCOFACTS® Deluxe Diabetes Management System

NCT ID: NCT00892151

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-04-30

Brief 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.

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

GLUCOFACTS® Deluxe

Intervention Type: DEVICE

Diabetes Data Management Software

Interventions

GLUCOFACTS® Deluxe

Diabetes Data Management Software

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascensia Diabetes Care

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

AMCR Institute

Locations

AMCR Institute

Escondido, California, United States

Countries

United States

Other Identifiers

CTD-2009-01

Identifier Type: -

Identifier Source: org_study_id