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%.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes

Detailed Description

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%).

• Study Type: Observational
• Enrollment (Anticipated): 330

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Keighley, West Yorkshire, United Kingdom, BD20 6TD
      • Recruiting
      • Airedale General Hospital
      • Contact: Richard Pope, MD; Phone Number: 01535292760

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects must be 18 years of age or older

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c	A point of care A1c measurement will serve as the reference method for defining pre-diabetes (6.0% ≤ A1c ≤6.4%) and diabetes (A1c ≥ 6.5%) The study will require one visit by each subject to the clinical site. The visit does not require fasting and can be done any time of day. The study (not including the IRB process and recruiting) is expected to last 6 months. The target cohort comprises persons at risk for pre-diabetes and/or type 2 diabetes.	Up to 6 months

Collaborators and Investigators

• Sponsor: VeraLight, Inc.
• Investigators: Principal Investigator: Richard Pope, MD, Airedale General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012

Study Registration Dates

• First Submitted: July 3, 2012
• First Submitted That Met QC Criteria: July 3, 2012
• First Posted (Estimate): July 6, 2012

Study Record Updates

• Last Update Posted (Estimate): July 6, 2012
• Last Update Submitted That Met QC Criteria: July 3, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Screening for Type 2 Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: VL2722