Screening for Early Evidence of Diabetes

Study Overview
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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.

Official Title
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A Prospective, Multi-Center, Paired Data, Cohort Screening Trial Comparing SCOUT to the Fasting Plasma Glucose Test in Subjects at Risk for Diabetes

Conditions
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Diabetes Mellitus, Type 2

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Produced SCOUT DS measurement algorithm. | Relative true positive and false positive fractions between Scout (Visit 2, nonfasting) and FPG (Visit 1, fasting) for detecting abnormal glucose tolerance, using the 2 hr OGTT ≥ 140 mg/dL as the threshold for a positive result. | At completion of second visit which occurs within 1 to 14 days after the first visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoints include the sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values of the Scout (Visit 2, nonfasting), FPG, and A1c tests for detection of abnormal glucose tolerance. |  | End of study | 
| Intra- and inter-day Scout test reproducibility. |  | End of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening