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Noninvasive Screening for Early Evidence of Diabetes With SCOUT DS (NSEEDS)

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ClinicalTrials.gov Identifier: NCT01375686
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
VeraLight, Inc.

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The study will complete up to 500 subjects across 9 clinical sites to evaluate the precision and accuracy of SCOUT DS (Diabetes Screening) subjects at risk for type 2 diabetes. The study will involve up to two unique Scout devices at each clinical site. Each site will initially contain only a CS-1 (Commercial SCOUT 1) "A" for collection of data. As they become available, CS-1 "B"s operating with latest version of SCOUT software will be shipped to each site.

The NSEEDS study will enroll patients at-risk for type 2 diabetes who meet the study inclusion criteria (and do not meet one or more of the exclusion criteria) at approximately 9 clinical sites distributed across the United States. Eligible subjects must be at least 18 years old, not have an existing diagnosis of diabetes and, if less than 45 years old, must have a body mass index (BMI) ≥ 25 and at least one other risk factor for type 2 diabetes.

The data will be collected and a partial area under the receiver operator curve (pAUC) will be computed via the method of moments between the 20% and 50% false positive rates based on the first valid Scout "A" measurement for each patient. The impaired glucose tolerance status will be determined by the average of the two hour, post challenge plasma glucose samples measured at the central laboratory. This will be compared to 1000 bootstrap re-samplings of the calibration data pulling a cohort that matches that collected during this study. A test will be conducted to assure that the SCOUT performance lies within a 95% empirical confidence interval based on the bootstrap re-sampling.


Condition or disease
Type 2 Diabetes

Study Design
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Study Type : Observational
Actual Enrollment : 486 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Screening for Early Evidence of Diabetes With SCOUT DS
Study Start Date : June 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Those at Risk for Type 2 diabetes
All subjects will be at risk for diabetes based on the American Diabetes Association (ADA) Standard of Care Guidelines.


Outcome Measures
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Primary Outcome Measures :
  1. Validation of SCOUT DS algorithm, ROC performance equivalent to FPG, A1c for detection abnormal glucose tolerance. [ Time Frame: 6 months ]
    The data will be collected and a partial area under the receiver operator curve (pAUC) will be computed via the method of moments between the 20% and 50% false positive rates based on the first valid Scout "A" measurement for each patient. The impaired glucose tolerance status will be determined by the average of the two hour, post challenge plasma glucose samples measured at the central laboratory. A test will be conducted to assure that the SCOUT performance lies within a 95% empirical confidence interval based on the bootstrap re-sampling.


Biospecimen Retention:   Samples Without DNA
Serum will be stored to later analyze lipids and insulin. This will be useful in understanding metabolic disorders experienced by the patients measured. These measurements can be used directly, or combined in a manner similar to the McAuley index to understand the risk of insulin insensitivity.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
In the study, volunteers age 18 and above, of either sex and of any ethnic background, will be recruited at up to 9 clinical sites. The number of sites may be decreased as the sponsor has the right to close a site due to protocol compliance or enrollment issues during the course of the study. All subjects will be at risk for diabetes based on the American Diabetes Association Standard of Care Guidelines. Subjects in the 18-44 age range must have a BMI > 25 plus an additional risk factor for type 2 diabetes.
Criteria

Inclusion Criteria:

  1. Age greater than or equal to 45 years;

    OR

  2. Age 18 to 44 years and a BMI > 25 with one or more of the following diabetes risk factors:

    • Habitually physically inactive (less than 30 minutes of moderate physical activity most, if not all, days of the week)
    • Has a first-degree relative with type 2 diabetes
    • African American, Latino, Native American, Asian American, Pacific Islander
    • Has delivered a baby weighing > 9 lb or previously diagnosed with gestational diabetes
    • Hypertension (≥140/≥ 90 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 years
    • Conditions associated with insulin resistance such as severe obesity or acanthosis nigricans
    • History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease

Exclusion Criteria:

  • Prior participation in VeraLight studies: VL-2701, VL-2710, VL-2711, VL-2712 , or VL-2718
  • Diagnosed with any type of diabetes, including type 1 or 2
  • Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
  • Receiving any investigational treatment 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
  • Taking glucose lowering medications*
  • 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.
  • 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 *
  • Prior bariatric surgery
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375686


Locations
United States, Colorado
Radiant Denver
Denver, Colorado, United States, 80239
Sponsors and Collaborators
VeraLight, Inc.
Investigators
Principal Investigator: Michael Kyle, MD Radiant Chicago
Principal Investigator: Tami Helmer, MD Radiant Minneapolis
Principal Investigator: Michael Noss, MD Radiant Cincinnati
Principal Investigator: William Jennings, MD Radiant San Antonio
Principal Investigator: Daniel Brune, MD Accelovance Peoria
Principal Investigator: Martin L Kabongo, MD Accelovance San Diego
Principal Investigator: Earl Martin, MD DM Clinical
Principal Investigator: Audrey Lacour, MD JUNO Research
Principal Investigator: David Bolshoun, MD Radiant Denver
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT01375686     History of Changes
Other Study ID Numbers: VL-2715
First Posted: June 17, 2011    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: December 2012

Keywords provided by VeraLight, Inc.:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases