Type 2 DiabetesTCOYDNCT01346033
Evaluation of SCOUT DS in Subjects With Type 2 Diabetes
An observational study of Type 2 Diabetes, run by VeraLight, Inc. at 1 site in United States.
Trial summary
The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2010
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Attendees of the Taking Control of Your Diabetes Health Fair, San Diego CA Convention Center
Who may be able to join
- Age greater than or equal to 18 years
- Self-reported diagnosis of type 2 diabetes
Who cannot join
- Not diagnosed with type 2 diabetes
- Diagnosed with type 1 diabetes
- Known to be pregnant (Self Reported)
- Receiving dialysis or having known renal compromise
- Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
- Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego Convention Center
San Diego, California, 92111
About this study
Official title: An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes
The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes.
Read the detailed description
Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm.
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Adults 18 years and older, Taking Control of Your Diabetes Health Fair
- Medical subject headings
- Diabetes Mellitus, Type 2
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 |
|---|---|---|
| Those with Type 2 diabetes | All subjects have been diagnosed with type 2 diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of SCOUT DS algorithm for detecting known type 2 diabetes
Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- VeraLight, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin L Kabongo, MD,PhD, Principal investigator, Accelovance San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346033
- Sponsor's protocol ID
- VL-2714
- Acronym
- TCOYD
- Status last verified
- Dec 2012
- First submitted
- 28 Apr 2011
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01346033
- Acronym / sponsor ID
- TCOYD / VL-2714
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Adults 18 years and older, Taking Control of Your Diabetes Health Fair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- VeraLight, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 2 May 2011 (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.
The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes.
Detailed description
Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Those with Type 2 diabetes | – | –All subjects have been diagnosed with type 2 diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Attendees of the Taking Control of Your Diabetes Health Fair, San Diego CA Convention Center
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years
- Self-reported diagnosis of type 2 diabetes
Key exclusion criteria (6 listed)
- Not diagnosed with type 2 diabetes
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
Validation of SCOUT DS algorithm for detecting known type 2 diabetes
Time frame: 1 day
Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes
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 4 Dec 2012.
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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.
Martin L Kabongo, MD,PhD principal investigator
Accelovance San Diego
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 Type 2 Diabetes, run by VeraLight, Inc. 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 2 inclusion and 6 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 4 Dec 2012. 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?
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?
Validation of SCOUT DS algorithm for detecting known type 2 diabetes (time frame: 1 day). 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 4 Dec 2012.