Evaluation of a Diabetes Data Managemen… | Clinical Trial

Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AMCR Institute

Escondido, California, 92026, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Persons working for a competitive medical device company.

Treatment and study plan

Primary outcomes

Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)

Time frame: 1-2 hours
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.
Number of Participants Rated as <= 3 (Success in Using the Program)

Time frame: 1-2 hours
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.
Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)

Time frame: 1-2 hours

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.

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Official study title

Evaluation of a Diabetes Data Management System In a Clinical Setting

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Jun 10, 2008
Registry last updated: Feb 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed