DiabetesNCT00923975
Evaluation of DIDGET TM World Reports
A study testing DIDGET World Web Community Reports in people with Diabetes, run by Ascensia Diabetes Care at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- DIDGET World Web Community Reports
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Healthcare professionals must:
- Have experience using the internet
- Have experience using diabetes data management software in the medical office
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Avatar Web Reports
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.
Read the 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
- Being tested
- DIDGET World Web Community Reports
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIDGET World Web Community ReportsDevice
Also called DIDGET World Web Community
During the study subjects performed specific tasks, such as uploading meter results to a secure website and displaying reports.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: DIDGET World Web Community Reports |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- = Successful ( no assistance)
- = Successful after staff prompted to view user instructions
- = Successful with verbal assistance or review of part of user instructions (as review a specific function during a Customer Service call)
- = Unsuccessful (Subject could not perform the task)
- = Subject could not perform task due to software or hardware failure after repeated attempt.
Measured: 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)
Subjects rated ease of using the software with respect to specific tasks. The rating scale was:
- = Very Simple
- = Simple
- = Neither Simple nor Difficult
- = Difficult
- = Very Difficult
Measured: 1-2 hours
Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)
After the software evaluation, subjects were asked to review the online help and rate it on a 5 point scale.
- = Unacceptable
- = Poor
- = Good
- = Very Good
- = Excellent
Measured: 1-2 hours
Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)
Subjects responded to questionnaires in rating features and appearance, usefulness, and satisfaction on a 5 point scale:
- = Unacceptable
- = Poor
- = Good
- = Very Good
- = Excellent
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascensia Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Bailey, MD, Principal investigator, AMCR Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923975
- Sponsor's protocol ID
- CTD-2009-08
- Status last verified
- Sep 2024
- First submitted
- 17 Jun 2009
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Avatar Web Reports
- ClinicalTrials.gov ID
- NCT00923975
- Acronym / sponsor ID
- CTD-2009-08
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ascensia Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Posted 8 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intended Users of the Software | Other | Device: DIDGET World Web Community ReportsYoung 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Lay users must be:
- Healthcare professionals must:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DIDGET World Web Community ReportsAlso: DIDGET World Web CommunityDuring the study subjects performed specific tasks, such as uploading meter results to a secure website and displaying reports. | Device | Intended Users of the Software |
Primary outcome
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks
Time frame: 1-2 hours
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.
3 secondary outcomes
Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating)
Time frame: 1-2 hours
Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)
Time frame: 1-2 hours
Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)
Time frame: 1-2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Bailey, MD principal investigator
AMCR Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIDGET World Web Community Reports in people with Diabetes, run by Ascensia Diabetes Care at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks (time frame: 1-2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.