Evaluation of a Diabetes Data Management System

NCT00694070 | Completed Results

• 1 other identifier: CTD-2008-11
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (3)

• 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. 1. Very Simple 2. Simple 3. Neither simple nor difficult 4. Difficult 5. Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3.

  1-2 hours

• 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: 1. successful 2. successful after being referred to user instructions 3. success with assistance (similar to a customer call) 4. unsuccessful 5 = software problem Outcome measure was the number of participants rated as \<= 3.

  1-2 hours

• 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

Study Arms (1)

health care professionals and lay users

h= 8 health care professionals p= 43 lay users

Eligibility Criteria

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

Study Population

Lay users males or females and health care professionals.

You may qualify if:

• Health Care Professionals:
• 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.
• May include: endocrinologists, primary care physicians, nurse educators, or other medical staff involved in downloading meters or interpreting the data output.
• Lay users must:
• Be at least 18 years of age.
• 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.
• Be able to speak, read and understand English.
• 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.
• Have experience using PC programs or browsing the internet.

You may not qualify if:

• Persons working for a competitive medical device company.

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: Clinical Research Scientist
• Organization: Ascensia Diabetes Care

574-257-3063

Study Officials

• Timothy Bailey, MD

  AMCR Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: June 10, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 29, 2016
• Results First Posted: September 23, 2009

Record last verified: 2016-01

Locations

US (1)