Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes

Diabetes Clinical Trial

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Official title:

An Evaluation of a Noninvasive Diabetes Screening Device in Subjects at Risk for Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080157
• Other study ID #: VL-2712
• Status: Completed
• Phase: N/A
• First received: March 1, 2010
• Last updated: December 3, 2012
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2012
• Source: VeraLight, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. The SCOUT DS is being developed to help doctors measure these substances in skin and possibly help doctors diagnose diabetes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age greater than or equal to 45 years; OR

2. 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

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Device:
• SCOUT DS measurement
Non-invasive 3-5 volar forearm scan

Locations

Country	Name	City	State
United States	Lovelace Scientific Resources, Inc.	Albuquerque	New Mexico
United States	Radiant Research, Inc. - Chicago	Chicago	Illinois
United States	Radiant Research, Inc. - Cincinnati	Cincinnati	Ohio
United States	Dynamed Clinical Research, LP	Houston	Texas
United States	Juno Research, LLC	Houston	Texas
United States	Accelovance - Huntsville	Huntsville	Alabama
United States	Radiant Research, Inc. - Kansas City	Kansas City	Kansas
United States	Radiant Research, Inc. - Minneapolis	Minneapolis	Minnesota
United States	Accelovance - Peoria, IL	Peoria	Illinois
United States	Accelovance - Rockville, MD	Rockville	Maryland
United States	Radiant Research, Inc. - San Antonio	San Antonio	Texas
United States	Accelovance - San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VeraLight, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Outcome measure is determined 2-3 months after completion of Visit 3	No
Secondary	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		Outcome measure is determined 2-3 months after completion of Visit 3	No