Screening for Early Evidence of Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3478 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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

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Diabetes Mellitus, Type 2

Keywords

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Screening

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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
* 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)

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Maynard, MS

Role: STUDY_DIRECTOR

Executive Vice President, VeraLight Inc.

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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VL-2701

Identifier Type: -

Identifier Source: org_study_id

Screening for Early Evidence of Diabetes

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

VeraLight, Inc.

Responsible Party

Principal Investigators

John Maynard, MS

Locations

Accelovance

Accelovance

Veteran's Administration Hospital

MedStar Research Institute

Kaiser Permanente-Center for Health Research

Radiant Research

Accelovance

Radiant Research

Radiant Research

Lovelace Scientific Resources

New York Hospital Queens-Lang Research Center

Radiant Research

Oklahoma Diabetes Center, University of Oklahoma

Diabetes and Lipid Research, University of Pittsburgh

Radiant Research

Countries

Other Identifiers

VL-2701