Evaluation of SCOUT DS Device in the Diagnosis of Diabetes

An Evaluation of the SCOUT DS Device. Random Capillary Glucose and Leicester Diabetes Risk Score for Screening Subjects at Risk for Type 2 Diabetes

The primary objective is to identify compare SCOUT DS to random capillary glucose for identification of at-risk subjects with dysglycemia defined by hemoglobin A1c ≥ 6.0%.

The study will complete up to 330 subjects at the clinical site to evaluate the accuracy of SCOUT DS, random capillary glucose (RCG) and the Leicester diabetes risk questionnaire for detecting prediabetes and undiagnosed type 2 diabetes in subjects at risk, but not having a pre-exiting diagnosis of type 2 diabetes. A point of care A1c measurement (Siemens DCA Vantage or Axis-Shield Afinion) will serve as the reference method for defining a positive screen (A1c ≥ 6.0%).

Inclusion Criteria:

• Age greater than or equal to 45 years

OR

Age 18 to 44 years and 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
• 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
  • Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)