Evaluation of SCOUT DS Device in the Diagnosis of Diabetes Mellitus

Inclusion Criteria:

• Age greater than or equal to 45 years

OR

Age 18 to 44 years and with one or more of the following risk factors:

• BMI > 25 kg/m²
• 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
• Ethnicity with elevated risk for type 2 diabetes
• 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:

• • 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 with the exception of metformin
  • 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)