Diabetes Mellitus, Non-Insulin DependentPOSSENCT01669616
Point of Service Diabetes Screening Evaluation
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, random capillary glucose and Hemoglobin A1c measurements from subject 18 years of age or older. 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
- 667 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jan 2013
- 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 Blue Cross Blue Shield Wellness Event
Who may be able to join
- 18 years of age or older
Who cannot join
- Known to be pregnant (self-reported)
- Receiving dialysis or known renal compromise
- Known to have photosensitivity
- Taking medications that fluoresce
- Have scars, any tattoos, rashes or other disruption/discoloration on the left volar forearm
Trial locations and contacts
1 site in 1 country.
United States1 site
Blue Cross Blue Shield of Louisiana
Baton Rouge, Louisiana, 70809
About this study
The primary objective of the trial is to collect SCOUT DS, random capillary glucose and Hemoglobin A1c measurements from subject 18 years of age or older.
Read the detailed description
The objectives of this study are to compare the accuracy of SCOUT versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1C-defined dysglycemia.
- Conditions
- Diabetes Mellitus, Non-Insulin Dependent
- Keywords
- Type 2 Diabetes, Adults 18 years and older
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the accuracy of SCOUT DS versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1c-defined dysglycemia.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionJan 2013
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
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- VeraLight, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Barrack, MD, Principal investigator, Blue Cross Blue Shield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669616
- Sponsor's protocol ID
- VL-2723
- Acronym
- POSSE
- Status last verified
- Jan 2013
- First submitted
- 23 Jul 2012
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Service Diabetes Screening Evaluation
- ClinicalTrials.gov ID
- NCT01669616
- Acronym / sponsor ID
- POSSE / VL-2723
- Conditions
- Diabetes Mellitus, Non-Insulin Dependent
- Keywords
- Type 2 Diabetes, Adults 18 years and older
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- VeraLight, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Aug 2012 (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, random capillary glucose and Hemoglobin A1c measurements from subject 18 years of age or older.
Detailed description
The objectives of this study are to compare the accuracy of SCOUT versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1C-defined dysglycemia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Attendees of Blue Cross Blue Shield Wellness Event
Key inclusion criteria (1 listed)
- 18 years of age or older
Key exclusion criteria (5 listed)
- Known to be pregnant (self-reported)
- Receiving dialysis or known renal compromise
- Known to have photosensitivity
- Taking medications that fluoresce
- Have scars, any tattoos, rashes or other disruption/discoloration on the left volar forearm
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
To compare the accuracy of SCOUT DS versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1c-defined dysglycemia.
Time frame: one week
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 15 Jan 2013.
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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.
Andrea Barrack, MD principal investigator
Blue Cross Blue Shield
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 5 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 15 Jan 2013. 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?
To compare the accuracy of SCOUT DS versus random capillary glucose and several diabetes risk assessment questionnaires for detection of HbA1c-defined dysglycemia. (time frame: one week). 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 15 Jan 2013.