Diabetes Mellitus, Type 2SEEDNCT00614783
Screening for Early Evidence of Diabetes
An observational study of Diabetes Mellitus, Type 2, run by VeraLight, Inc. at 15 sites in United States.
Trial summary
This is a pivotal study to determine the accuracy of a new device (SCOUT) in screening persons for pre-diabetes or diabetes. SCOUT will be compared to the standard screening test (Fasting Plasma Glucose), using the Oral Glucose Tolerance Test as the reference standard. 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, Type 2
- How many people
- 3,478 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2007to Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population who are 'at risk' for pre-diabetes or diabetes.
Who may be able to join
- Age greater than or equal to 45 years
- OR
- Age 18 to 44 years, with two or more of the following risk factors:
- Overweight (BMI ≥ 25 kg/m2)
- Elevated waist circumference, >35 inches for women and >40 inches for men
- Habitually physically inactive
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- Has a first-degree relative with diabetes
- African American, Latino, Native American, Asian American, Pacific Islander
- Delivered a baby weighing >9 lb or diagnosed with gestational diabetes
- Hypertension (>130/>85 mm Hg) or being treated for hypertension
- HDL cholesterol <35 mg/dL and/or triglycerides >250 mg/dL or being treated for dyslipidemia with medication
- Previously diagnosed with Polycystic Ovary Syndrome (PCOS)
- Abnormal Glucose Tolerance on previous testing within the last 3 years
- Has a condition associated with insulin resistance (e.g., acanthosis nigricans)
- History of vascular disease (e.g., heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure, or peripheral arterial disease)
Who cannot join
- Prior bariatric surgery
- Diagnosed with type 1 or 2 diabetes
- Taking glucose lowering medications
- Receiving dialysis or having known renal compromise
- Receiving investigational treatments
- Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm
Show all 14Show fewer
- Recent or current oral steroid therapy or topical steroids applied to the left forearm
- Current chemotherapy, or chemotherapy within the past 12 months
- Conditions that cause secondary diabetes (e.g., Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis)
- Receiving other investigational treatments
- Receiving drugs that fluoresce (e.g., Doxorubicin, Daunomycin, Camptothecin, Protoporphyrin, Fluoroquinolones, Tetracycline, Hydroxychloroquine or Quinidine)
- Known to be pregnant
- Psychosocial issues that interfere with an ability to follow study procedures
- 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
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108
Radiant Research
Chicago, Illinois, 60610
Radiant Research
Cincinnati, Ohio, 45249
Radiant Research
Edina, Minnesota, 55435
New York Hospital Queens-Lang Research Center
Flushing, New York, 11355
Kaiser Permanente-Center for Health Research
Honolulu, Hawaii, 96813
Accelovance
Huntsville, Alabama, 35802
Oklahoma Diabetes Center, University of Oklahoma
Oklahoma City, Oklahoma, 73104
Radiant Research
Overland Park, Kansas, 66202
Accelovance
Peoria, Illinois, 61602
Diabetes and Lipid Research, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Radiant Research
San Antonio, Texas, 78229
Accelovance
San Diego, California, 92108
Veteran's Administration Hospital
San Diego, California, 92161
MedStar Research Institute
Washington D.C., District of Columbia, 20003
About this study
Official title: A Prospective, Multi-Center, Paired Data, Cohort Screening Trial Comparing SCOUT to the Fasting Plasma Glucose Test in Subjects at Risk for Diabetes
This is a pivotal study to determine the accuracy of a new device (SCOUT) in screening persons for pre-diabetes or diabetes. SCOUT will be compared to the standard screening test (Fasting Plasma Glucose), using the Oral Glucose Tolerance Test as the reference standard.
SCOUT uses a rapid, noninvasive, light-based technology to measure the concentration of chemicals in the skin called advanced glycation endproducts (AGEs). Several studies have demonstrated that AGEs accumulate in skin faster in individuals with poor control of blood sugar.
Persons will be eligible for the study if they are 'at risk' for diabetes based on their age and other risk factors as defined by the American Diabetes Association.
Read the detailed description
Current methods for detecting pre-diabetes and diabetes are inconvenient and inaccurate. The most widely used screening test, Fasting Plasma Glucose (FPG), requires an overnight fast and a blood draw. FPG also has poor sensitivity contributing to late diagnoses. A more accurate and convenient screening method, like SCOUT, will improve early detection and allow the physician to begin a treatment regimen to prevent or delay the development of the disease and its serious complications.
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Screening
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Produced SCOUT DS measurement algorithm.
Relative true positive and false positive fractions between Scout (Visit 2, nonfasting) and FPG (Visit 1, fasting) for detecting abnormal glucose tolerance, using the 2 hr OGTT ≥ 140 mg/dL as the threshold for a positive result.
Measured: At completion of second visit which occurs within 1 to 14 days after the first visit.
Secondary outcomes (2)
Secondary endpoints include the sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values of the Scout (Visit 2, nonfasting), FPG, and A1c tests for detection of abnormal glucose tolerance.
Measured: End of study
Intra- and inter-day Scout test reproducibility.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startMay 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Prospective
- Enrolment
- 3,478 participants (actual)
Sponsor and investigators
- Lead sponsor
- VeraLight, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Maynard, MS, Study director, Executive Vice President, VeraLight Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614783
- Sponsor's protocol ID
- VL-2701
- Acronym
- SEED
- Status last verified
- Dec 2012
- First submitted
- 30 Jan 2008
- 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
- A Prospective, Multi-Center, Paired Data, Cohort Screening Trial Comparing SCOUT to the Fasting Plasma Glucose Test in Subjects at Risk for Diabetes
- ClinicalTrials.gov ID
- NCT00614783
- Acronym / sponsor ID
- SEED / VL-2701
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,478 participants (actual)
- Lead sponsor
- VeraLight, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Feb 2008 (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.
This is a pivotal study to determine the accuracy of a new device (SCOUT) in screening persons for pre-diabetes or diabetes. SCOUT will be compared to the standard screening test (Fasting Plasma Glucose), using the Oral Glucose Tolerance Test as the reference standard.
SCOUT uses a rapid, noninvasive, light-based technology to measure the concentration of chemicals in the skin called advanced glycation endproducts (AGEs). Several studies have demonstrated that AGEs accumulate in skin faster in individuals with poor control of blood sugar.
Persons will be eligible for the study if they are 'at risk' for diabetes based on their age and other risk factors as defined by the American Diabetes Association.
Detailed description
Current methods for detecting pre-diabetes and diabetes are inconvenient and inaccurate. The most widely used screening test, Fasting Plasma Glucose (FPG), requires an overnight fast and a blood draw. FPG also has poor sensitivity contributing to late diagnoses. A more accurate and convenient screening method, like SCOUT, will improve early detection and allow the physician to begin a treatment regimen to prevent or delay the development of the disease and its serious complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population who are 'at risk' for pre-diabetes or diabetes.
Key inclusion criteria (15 listed)
- Age greater than or equal to 45 years
- OR
- Overweight (BMI ≥ 25 kg/m2)
- Elevated waist circumference, >35 inches for women and >40 inches for men
- Habitually physically inactive
Key exclusion criteria (14 listed)
- Prior bariatric surgery
- Diagnosed with type 1 or 2 diabetes
- Taking glucose lowering medications
- Receiving dialysis or having known renal compromise
- Receiving investigational treatments
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
Produced SCOUT DS measurement algorithm.
Time frame: At completion of second visit which occurs within 1 to 14 days after the first visit.
Relative true positive and false positive fractions between Scout (Visit 2, nonfasting) and FPG (Visit 1, fasting) for detecting abnormal glucose tolerance, using the 2 hr OGTT ≥ 140 mg/dL as the threshold for a positive result.
2 secondary outcomes
Secondary endpoints include the sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values of the Scout (Visit 2, nonfasting), FPG, and A1c tests for detection of abnormal glucose tolerance.
Time frame: End of study
Intra- and inter-day Scout test reproducibility.
Time frame: End of study
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.
John Maynard, MS study director
Executive Vice President, VeraLight Inc.
15 sites 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, Type 2, run by VeraLight, Inc. at 15 sites 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 15 inclusion and 14 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 15 sites 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?
Produced SCOUT DS measurement algorithm. (time frame: At completion of second visit which occurs within 1 to 14 days after the first visit.). 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.