Evaluation of DIDGET TM World Reports

NCT ID: NCT00923975

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2009-06-30

Brief Summary

The purpose of this study is to evaluate a Diabetes data management program in the hands of potential users, both lay persons and healthcare professionals. With this data management system glucose results from the DIDGET TM meter can be uploaded to a secure website and used by adults with diabetes, by parents and guardians of children with diabetes, and by health care professionals to monitor diabetes by recognizing trends and patterns in blood sugar levels.

Detailed Description

Diabetes data management programs upload glucose meter results to computers to provide information to lay persons and their health care professionals. With this data management system glucose results from the DIDGET TM meter can be uploaded to a secure website and used by adults with diabetes, by parents and guardians of children with diabetes, and by health care professionals to monitor diabetes by recognizing trends and patterns in blood sugar levels. During the study subjects performed specific tasks, such as uploading meter results and displaying reports. The study evaluates the subjects' success in using the software program, the program's ease of use, clarity and usefulness of user instructions, and user satisfaction with the diabetes data management program.

Conditions

Diabetes

Study Design

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

Study Groups

Intended Users of the Software

Young adults, parents/guardians of young people under age 18, and healthcare professionals who work with this population would be intended users of the data management program. The DIDGET World Reports software is used to upload blood glucose results from the DIDGET Blood Glucose Monitoring System so that intended users can identify patterns in their diabetes management.

Group Type: OTHER

DIDGET World Web Community Reports

Intervention Type: DEVICE

During the study subjects performed specific tasks, such as uploading meter results to a secure website and displaying reports.

Interventions

DIDGET World Web Community Reports

During the study subjects performed specific tasks, such as uploading meter results to a secure website and displaying reports.

Intervention Type: DEVICE

Other Intervention Names

DIDGET World Web Community

Eligibility Criteria

Inclusion Criteria

• Lay users must be:

1. Be at least 18 years of age

2. Have diabetes or be the parent or legal guardian of a child with diabetes

3. 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

4. Be able to speak, read, and understand English

5. Have experience using a PC, navigating software programs, or browsing the internet

• Healthcare professionals must:

1. Have experience using the internet

2. Have experience using diabetes data management software in the medical office

Exclusion Criteria

1. Person working for a competitive medical device company

2. 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
• Maximum Eligible Age: 80 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-2009-08

Identifier Type: -

Identifier Source: org_study_id