Clinical trial NCT00923975: Evaluation of DIDGET TM World Reports
Official title: Evaluation of Avatar Web Reports
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2009-06-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
timeFrame: 1-2 hours
Secondary outcomes:
measure: Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating)
timeFrame: 1-2 hours
measure: Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)
timeFrame: 1-2 hours
measure: Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)
timeFrame: 1-2 hours
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
Study officials:
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References: