DiabetesNCT00694070
Evaluation of a Diabetes Data Management System
An observational study of 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 health care professionals and lay users. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2008
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lay users males or females and health care professionals.
Who may be able to join
- Health Care Professionals:
- 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.
- May include: endocrinologists, primary care physicians, nurse educators, or other medical staff involved in downloading meters or interpreting the data output.
- Lay users must:
- Be at least 18 years of age.
- 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.
Show all 9Show fewer
- Be able to speak, read and understand English.
- 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.
- Have experience using PC programs or browsing the internet.
Who cannot join
- Persons working for a competitive medical device company.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Diabetes Data Management System In a Clinical Setting
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.
Read the detailed 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.
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| health care professionals and lay users | h= 8 health care professionals p= 43 lay users |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)
After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5.
- Very Simple
- Simple
- Neither simple nor difficult
- Difficult
- Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3.
Measured: 1-2 hours
Number of Participants Rated as <= 3 (Success in Using the Program)
Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was:
- successful
- successful after being referred to user instructions
- success with assistance (similar to a customer call)
- unsuccessful 5 = software problem Outcome measure was the number of participants rated as <= 3.
Measured: 1-2 hours
Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)
Subjects were asked thirty questions throughout the evaluation to test whether they understood the data displays, graphs and features of the software. Outcome measure was the number of participants that could answer at least 85% of the comprehension questions correctly.
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 posted10 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2008
- Study completionJul 2008
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- 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
- NCT00694070
- Sponsor's protocol ID
- CTD-2008-11
- Status last verified
- Jan 2016
- First submitted
- 6 Jun 2008
- Last updated
- 29 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Diabetes Data Management System In a Clinical Setting
- ClinicalTrials.gov ID
- NCT00694070
- Acronym / sponsor ID
- CTD-2008-11
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ascensia Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 10 Jun 2008 (estimated)
- Results
- Posted 23 Sep 2009
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 health care professionals and lay users.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| health care professionals and lay users | – | –h= 8 health care professionals p= 43 lay users |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lay users males or females and health care professionals.
Key inclusion criteria (9 listed)
- Health Care Professionals:
- Lay users must:
Key exclusion criteria (1 listed)
- Persons working for a competitive medical device company.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)
Time frame: 1-2 hours
After completing each task, subjects rated the ease of performing each task on a scale of 1 to 5. 1. Very Simple 2. Simple 3. Neither simple nor difficult 4. Difficult 5. Very Difficult Outcome measure was the number of participants that rated 80% of tasks as 1,2, or 3.
Number of Participants Rated as <= 3 (Success in Using the Program)
Time frame: 1-2 hours
Subjects were rated by study staff as to their success at performing basic tasks. The rating scale was: 1. successful 2. successful after being referred to user instructions 3. success with assistance (similar to a customer call) 4. unsuccessful 5 = software problem Outcome measure was the number of participants rated as <= 3.
Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)
Time frame: 1-2 hours
Subjects were asked thirty questions throughout the evaluation to test whether they understood the data displays, graphs and features of the software. Outcome measure was the number of participants that could answer at least 85% of the comprehension questions correctly.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- 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?
An observational study of 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 1 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 29 Feb 2016. 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 23 Sep 2009). 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 That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program) (time frame: 1-2 hours). The study lists 3 primary outcomes in all. 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 29 Feb 2016.