Diabetes Mellitus, Non-Insulin DependentTCOYD2NCT01346046
Evaluation of SCOUT DS in Subjects With Type 2 Diabetes #2
An observational study of Diabetes Mellitus, Non-Insulin Dependent, 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 olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin Dependent
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Aug 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Attendees of the Taking Control of Your Diabetes Health Fair, Albuquerque Convention Center
Who may be able to join
- Age greater than or equal to 18 years Self-reported diagnosis of type 2 diabetes No Self-reported diagnosis of type 2 diabetes
Who cannot join
- Less than 18 years of age
- 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
Albuquerque Convention Center
Albuquerque, New Mexico, 87102
About this study
Official title: An Evaluation of a Noninvasive Diabetes Screening Device in Subjects at the TCOYD Diabetes Conference
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
- Diabetes Mellitus, Non-Insulin Dependent
- 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 | 270 subjects with Type 2 diabetes | |
| Non diabetic | 30 healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuing validation of SCOUT DS algorithm
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 startMay 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Non-Insulin DependentStudies 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
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VeraLight, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Walter Forman, MD, Principal investigator, Lovelace Scientific Resources
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346046
- Sponsor's protocol ID
- VL-2717
- Acronym
- TCOYD2
- Status last verified
- Dec 2012
- First submitted
- 28 Apr 2011
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a Noninvasive Diabetes Screening Device in Subjects at the TCOYD Diabetes Conference
- ClinicalTrials.gov ID
- NCT01346046
- Acronym / sponsor ID
- TCOYD2 / VL-2717
- Conditions
- Diabetes Mellitus, Non-Insulin Dependent
- Keywords
- Type 2 Diabetes, Adults 18 years and older, Taking Control of Your Diabetes Health Fair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- VeraLight, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (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
- 2
| Arm | Type | Receives |
|---|---|---|
| Those with Type 2 diabetes | – | –270 subjects with Type 2 diabetes |
| Non diabetic | – | –30 healthy subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Attendees of the Taking Control of Your Diabetes Health Fair, Albuquerque Convention Center
Key inclusion criteria (1 listed)
- Age greater than or equal to 18 years Self-reported diagnosis of type 2 diabetes No Self-reported diagnosis of type 2 diabetes
Key exclusion criteria (6 listed)
- Less than 18 years of age
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
Continuing validation of SCOUT DS algorithm
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 5 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.
Walter Forman, MD principal investigator
Lovelace Scientific Resources
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 Mellitus, Non-Insulin Dependent, 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 1 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 5 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?
Continuing validation of SCOUT DS algorithm (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 5 Dec 2012.