Evaluation of DIDGET TM World Reports

NCT00923975 | Completed Results

• 1 other identifier: CTD-2009-08
• Study Type: interventional
• 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 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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks

  Study staff rated participants on their success at performing specific tasks. The rating scale was: 1. = Successful ( no assistance) 2. = Successful after staff prompted to view user instructions 3. = Successful with verbal assistance or review of part of user instructions (as review a specific function during a Customer Service call) 4. = Unsuccessful (Subject could not perform the task) 5. = Subject could not perform task due to software or hardware failure after repeated attempt.

  1-2 hours

Secondary Outcomes (3)

• Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating)

  1-2 hours

• Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)

  1-2 hours

• Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)

  1-2 hours

Study Arms (1)

Intended Users of the Software

OTHER

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.

Device: DIDGET World Web Community Reports

Interventions

DIDGET World Web Community Reports DEVICE

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

Also known as: DIDGET World Web Community

Intended Users of the Software

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lay users must be:
• Be at least 18 years of age
• Have diabetes or be the parent or legal guardian of a child with diabetes
• 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 a PC, navigating software programs, or browsing the internet
• Healthcare professionals must:
• Have experience using the internet
• Have experience using diabetes data management software in the medical office

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: June 17, 2009
• First Posted: June 18, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 23, 2024
• Results First Posted: October 8, 2010

Record last verified: 2024-09

Locations

US (1)