Evaluation of Low Source of Signal in SCOUT DS

Inclusion criteria

• Dark Skin Tone (Von Luschan chromatic skin color > 35)
• Age greater than or equal to 45 years;

OR

• Age 18 to 44 years and a BMI > 25 kg/m² 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 under VeraLight protocols: VL-2710, VL-2711 or VL-2712
• Under 18 years of age
• 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)
• Known to have, or at risk for, sensitivity to skin lotions or shaving (creams, lotions, soap, shaving cream)
• Prior bariatric surgery