Evaluation of GLUCOFACTS® Deluxe Diabetes Management System

NCT00892151 | Completed Results

• 1 other identifier: CTD-2009-01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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: 1. = Successful 2. = Successful after being referred to user instructions 3. = Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) 4. = Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.) 5. = Problem encountered with software

  1-2 hours

Secondary Outcomes (2)

• Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3

  1-2 hours

• Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3

  1-2 hours

Study Arms (1)

Intended Users of the Software

EXPERIMENTAL

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.

Device: GLUCOFACTS® Deluxe

Interventions

GLUCOFACTS® Deluxe DEVICE

Diabetes Data Management Software

Intended Users of the Software

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (1)

AMCR Institute

Escondido, California, 92026, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Carmine Greene, Senior Clinical Research Scientist
• Organization: Ascensia Diabetes Care

carmine.greene@ascensia.com

574-257-3040

Study Officials

• Timothy Bailey, MD

  AMCR Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2009
• First Posted: May 4, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 29, 2016
• Results First Posted: May 18, 2010

Record last verified: 2016-01

Locations

US (1)