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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes

• Study Type: Observational
• Enrollment (Actual): 486

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80239
      • Radiant Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of SCOUT DS algorithm, ROC performance equivalent to FPG, A1c for detection abnormal glucose tolerance.	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.	6 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 15, 2011
• First Submitted That Met QC Criteria: June 16, 2011
• First Posted (Estimate): June 17, 2011

Study Record Updates

• Last Update Posted (Estimate): December 4, 2012
• Last Update Submitted That Met QC Criteria: December 3, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: VL-2715