Evaluation of a Diabetes Data Management System

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Study type: Observational

Funder types: Industry

Identifiers

NCT00694070

CTD-2008-11

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Health Care Professionals:

  1. 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.
  2. May include: endocrinologists, primary care physicians, nurse educators, or other medical staff involved in downloading meters or interpreting the data output.

• Lay users must:

  1. Be at least 18 years of age.
  2. 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.
  3. Be able to speak, read and understand English.
  4. 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.
  5. Have experience using PC programs or browsing the internet.

Exclusion criteria

• Persons working for a competitive medical device company.

Trial design

51 participants in 1 patient group

health care professionals and lay users

Description:

h= 8 health care professionals p= 43 lay users