DiabetesENGINENCT01080157
Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes
An observational study of Diabetes, run by VeraLight, Inc. at 12 sites in United States.
Trial summary
The purpose of this research study is to test the safety and effectiveness of the SCOUT DS in measuring the concentration of substances (advanced glycation endproducts) in the skin. These substances have been found to be in higher concentrations in people with diabetes and high blood sugar. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- SCOUT DS measurement
- Type of treatment
- Medical device
- How many people
- 509 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2010to 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: Volunteers age 18 and above, of either sex and of any ethnic background, will be recruited at up to 12 clinical sites. All subjects will be at risk for diabetes based on the American Diabetes Association Standard of Care Guidelines. Those in the 18-44 age group will have an additional risk factor, and the addition of the waist circumference and hypertension thresholds from the National Cholesterol Education Program Adult Treatment Panel III Guidelines for metablolic syndrome
Who may be able to join
- Age greater than or equal to 45 years; OR
- Age 18 to 44 years and a BMI > 25 kg/m² with one or more of the following risk factors:
- Elevated waist circumference, > 35 inches for women and >40 inches for men
- Habitually physically inactive (does not exercise regularly)
- Has a first-degree relative with diabetes
- African American, Latino, Native American, Asian American, Pacific Islander
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- Has delivered a baby weighing > 9 lb or diagnosed with gestational diabetes
- Hypertension (≥130/≥ 85 mmHg) or being treated for hypertension
- HDL cholesterol level < 35 mg/dL and/or a fasting triglyceride level ≥ 250 mg/dL or being treated for dyslipidemia with medication
- Has been previously diagnosed with Polycystic Ovary Syndrome (PCOS)
- Had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 yrs
- Conditions associated with insulin resistance such as acanthosis nigricans
- History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease
Who cannot join
- Prior participation in VL-2701
- Receiving investigational treatments in the past 14 days
- Psychosocial issues that interfere with an ability to follow study procedures
- Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis
- Diagnosed with any type of diabetes, including type 1 or 2
- Taking glucose lowering medications
Show all 13Show fewer
- Known to be pregnant
- Receiving dialysis or having known renal compromise
- Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
- Recent (within past month) or current oral steroid therapy or topical steroids applied to the left forearm; inhaled steroid therapy is not excluded Current chemotherapy, or chemotherapy within the past 12 months
- Receiving medications that fluoresce
- Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
- Prior bariatric surgery
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, 87108
Radiant Research, Inc. - Chicago
Chicago, Illinois, 60654
Radiant Research, Inc. - Cincinnati
Cincinnati, Ohio, 45249
Juno Research, LLC
Houston, Texas, 77036
Dynamed Clinical Research, LP
Houston, Texas, 77375
Accelovance - Huntsville
Huntsville, Alabama, 35802
Radiant Research, Inc. - Kansas City
Kansas City, Kansas, 66202
Radiant Research, Inc. - Minneapolis
Minneapolis, Minnesota, 55345
Accelovance - Peoria, IL
Peoria, Illinois, 61602
Accelovance - Rockville, MD
Rockville, Maryland
Radiant Research, Inc. - San Antonio
San Antonio, Texas, 78229
Accelovance - San Diego, CA
San Diego, California, 92108
About this study
Official title: An Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes
The purpose of this research study is to test the safety and effectiveness of the SCOUT DS in measuring the concentration of substances (advanced glycation endproducts) in the skin. These substances have been found to be in higher concentrations in people with diabetes and high blood sugar. The SCOUT DS is being developed to help doctors measure these substances in skin and possibly help doctors diagnose diabetes.
Read the detailed description
The trial will be a prospective, multi-center, paired data, cohort screening trial. Up to 960 subjects will complete the study to determine the relative accuracy of SCOUT DS compared to the FPG and HbA1c tests in screening for abnormal glucose tolerance. All methods will be compared to the 2 hour value of the OGTT. An algorithm utilizes skin optical modeling as well as the spectral and blood assay data accumulated from the initial phase of the study to produce a risk score for abnormal glucose tolerance. This algorithm and the calculation of the score will be integrated into the SCOUT DS for prospective testing. The design requires three patient visits to the clinical site and up to a total of seven measurements on the SCOUT device.
- Conditions
- Diabetes
- Being tested
- SCOUT DS measurement
- Keywords
- Diabetes, Diabetes Screening, Experimental Medical Device
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCOUT DS measurementDevice
Non-invasive 3-5 volar forearm scan
| Study group | Role | What they receive |
|---|---|---|
| Volunteers 18+, at risk for diabetes | Not described Receives: Device: SCOUT DS measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of SCOUT DS algorithm, ROC performance equivalency to FPG and A1c for detection of abnormal glucose tolerance.
The relative true positive and relative true negative fractions between the SCOUT DS and FPG tests for detecting abnormal glucose tolerance (2 hr OGTT value ≥ 140 mg/dL)
Measured: Outcome measure is determined 2-3 months after completion of Visit 3
Secondary outcomes (1)
Receiver operator characteristic area under the curve, sensitivity, specificity, and postive & negative predictive values of the SCOUT DS, FPG, and A1C tests for detection of abnormal glucose tolerance, and the intra- & inter-day SCOUT DS test
Measured: Outcome measure is determined 2-3 months after completion of Visit 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMar 2010
- 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 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
- Prospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- VeraLight, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Maynard, MS, Study director, VeraLight, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080157
- Sponsor's protocol ID
- VL-2712
- Acronym
- ENGINE
- Status last verified
- Dec 2012
- First submitted
- 1 Mar 2010
- 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 Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes
- ClinicalTrials.gov ID
- NCT01080157
- Acronym / sponsor ID
- ENGINE / VL-2712
- Conditions
- Diabetes
- Keywords
- Diabetes, Diabetes Screening, Experimental Medical Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- VeraLight, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Mar 2010 (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 purpose of this research study is to test the safety and effectiveness of the SCOUT DS in measuring the concentration of substances (advanced glycation endproducts) in the skin. These substances have been found to be in higher concentrations in people with diabetes and high blood sugar. The SCOUT DS is being developed to help doctors measure these substances in skin and possibly help doctors diagnose diabetes.
Detailed description
The trial will be a prospective, multi-center, paired data, cohort screening trial. Up to 960 subjects will complete the study to determine the relative accuracy of SCOUT DS compared to the FPG and HbA1c tests in screening for abnormal glucose tolerance. All methods will be compared to the 2 hour value of the OGTT. An algorithm utilizes skin optical modeling as well as the spectral and blood assay data accumulated from the initial phase of the study to produce a risk score for abnormal glucose tolerance. This algorithm and the calculation of the score will be integrated into the SCOUT DS for prospective testing. The design requires three patient visits to the clinical site and up to a total of seven measurements on the SCOUT device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers 18+, at risk for diabetes | – | Device: SCOUT DS measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers age 18 and above, of either sex and of any ethnic background, will be recruited at up to 12 clinical sites. All subjects will be at risk for diabetes based on the American Diabetes Association Standard of Care Guidelines. Those in the 18-44 age group will have an additional risk factor, and the addition of the waist circumference and hypertension thresholds from the National Cholesterol Education Program Adult Treatment Panel III Guidelines for metablolic syndrome
Key inclusion criteria (13 listed)
- Age greater than or equal to 45 years; OR
- Age 18 to 44 years and a BMI > 25 kg/m² with one or more of the following risk factors:
Key exclusion criteria (13 listed)
- Prior participation in VL-2701
- Receiving investigational treatments in the past 14 days
- Psychosocial issues that interfere with an ability to follow study procedures
- Conditions that cause secondary diabetes including Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis
- Diagnosed with any type of diabetes, including type 1 or 2
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 |
|---|---|---|
| SCOUT DS measurementNon-invasive 3-5 volar forearm scan | Device | Volunteers 18+, at risk for diabetes |
Primary outcome
Validation of SCOUT DS algorithm, ROC performance equivalency to FPG and A1c for detection of abnormal glucose tolerance.
Time frame: Outcome measure is determined 2-3 months after completion of Visit 3
The relative true positive and relative true negative fractions between the SCOUT DS and FPG tests for detecting abnormal glucose tolerance (2 hr OGTT value ≥ 140 mg/dL)
1 secondary outcome
Receiver operator characteristic area under the curve, sensitivity, specificity, and postive & negative predictive values of the SCOUT DS, FPG, and A1C tests for detection of abnormal glucose tolerance, and the intra- & inter-day SCOUT DS test
Time frame: Outcome measure is determined 2-3 months after completion of Visit 3
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
VeraLight, Inc.
12 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, run by VeraLight, Inc. at 12 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 13 inclusion and 13 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 12 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?
Validation of SCOUT DS algorithm, ROC performance equivalency to FPG and A1c for detection of abnormal glucose tolerance. (time frame: Outcome measure is determined 2-3 months after completion of Visit 3). 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.