Diabetes MellitusNCT02276131
Human Factors and Home Use Study of the Vigilant Diabetes Management Application
A study testing Vigilant Diabetes Management Application in people with Diabetes Mellitus, run by InSpark Technologies, Inc..
Trial summary
A human factors and home use study to assess whether subjects with diabetes and their caregivers can understand feedback received from the Vigilant Diabetes Management Application about their blood glucose patterns and whether the decisions made in response to device feedback are made in accordance with the intended… Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Vigilant Diabetes Management Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persons with diabetes mellitus testing blood glucose 3 or more times per day
- Clinicians who see diabetes patients
Who cannot join
- Admission for diabetic ketoacidosis in the 6 months prior to enrollment
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
- Patients who are not willing to share their glucose meter data, or do not perform the tasks asked of them and follow instructions for the study will be excluded
- Pregnancy
About this study
A human factors and home use study to assess whether subjects with diabetes and their caregivers can understand feedback received from the Vigilant Diabetes Management Application about their blood glucose patterns and whether the decisions made in response to device feedback are made in accordance with the intended use.
- Conditions
- Diabetes Mellitus
- Being tested
- Vigilant Diabetes Management Application
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigilant Diabetes Management ApplicationDevice
Human factors and usability assessment of the device in the hands of diabetes subjects and caregivers
| Study group | Role | What they receive |
|---|---|---|
| Usability testing | Experimental | Patients will participate in summative human factors testing of the Vigilant Diabetes Management Application in a controlled environment and during home use testing. Clinicians will participate in summative human factors testing in a controlled environment. Receives: Device: Vigilant Diabetes Management Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate understanding of algorithmic feedback based on surveyed responses (Measure: units on a scale)
An exit questionnaire will survey participants about comprehension of algorithmic feedback. Across all 5-point rating scales, the average rating will be determined.
Measured: 1 month home use
Successful completion of frequent and risk-related tasks (Measure: Percent of tasks successfully completed)
Percent successful initial or reattempt task completion across the range of usability tasks. Example: One task is to access the "Trends" screen to review and interpret weekly and monthly trend data for blood glucose variability and average glucose values.
Measured: Controlled in-office testing for up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSpark Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
- Investigators
- Stacey Anderson, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276131
- Sponsor's protocol ID
- VG1HFHUS1
- Status last verified
- Feb 2016
- First submitted
- 20 Oct 2014
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Factors and Home Use Study of the Vigilant Diabetes Management Application
- ClinicalTrials.gov ID
- NCT02276131
- Acronym / sponsor ID
- VG1HFHUS1
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- InSpark Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A human factors and home use study to assess whether subjects with diabetes and their caregivers can understand feedback received from the Vigilant Diabetes Management Application about their blood glucose patterns and whether the decisions made in response to device feedback are made in accordance with the intended use.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usability testing | Experimental | Device: Vigilant Diabetes Management ApplicationPatients will participate in summative human factors testing of the Vigilant Diabetes Management Application in a controlled environment and during home use testing. Clinicians will participate in summative human factors testing in a controlled environment. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Persons with diabetes mellitus testing blood glucose 3 or more times per day
- Clinicians who see diabetes patients
Key exclusion criteria (4 listed)
- Admission for diabetic ketoacidosis in the 6 months prior to enrollment
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
- Patients who are not willing to share their glucose meter data, or do not perform the tasks asked of them and follow instructions for the study will be excluded
- Pregnancy
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 |
|---|---|---|
| Vigilant Diabetes Management ApplicationHuman factors and usability assessment of the device in the hands of diabetes subjects and caregivers | Device | Usability testing |
Primary outcome
Adequate understanding of algorithmic feedback based on surveyed responses (Measure: units on a scale)
Time frame: 1 month home use
An exit questionnaire will survey participants about comprehension of algorithmic feedback. Across all 5-point rating scales, the average rating will be determined.
Successful completion of frequent and risk-related tasks (Measure: Percent of tasks successfully completed)
Time frame: Controlled in-office testing for up to 2 hours
Percent successful initial or reattempt task completion across the range of usability tasks. Example: One task is to access the "Trends" screen to review and interpret weekly and monthly trend data for blood glucose variability and average glucose values.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
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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.
Stacey Anderson, MD principal investigator
University of Virginia
Questions about this trial
What is this clinical trial studying?
A study testing Vigilant Diabetes Management Application in people with Diabetes Mellitus, run by InSpark Technologies, Inc..
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 2 inclusion and 4 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 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adequate understanding of algorithmic feedback based on surveyed responses (Measure: units on a scale) (time frame: 1 month home use). The study lists 2 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 24 Feb 2016.