Evaluation of SCOUT DS Device in the Diagnosis of Diabetes Mellitus

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: Completed
• Conditions: Type 2 Diabetes

Detailed Description

The study will complete up to 400 subjects at the clinical site to evaluate the precision and accuracy of SCOUT DS and random capillary glucose for detecting pre-diabetes and undiagnosed type 2 diabetes in subjects at risk but not having a pre-existing diagnosis of type 2 diabetes. 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 for comprises persons at risk for pre-diabetes and/or type 2 diabetes.

• Study Type: Observational
• Enrollment (Actual): 409

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • Greece National Social Insurance Institute (IKA)

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 greater.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of SCOUT DS to Random Capillary Glucose	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 for comprises persons at risk for pre-diabetes and/or type 2 diabetes.	Up to 6 months

Collaborators and Investigators

• Sponsor: VeraLight, Inc.
• Collaborators: Laikο General Hospital, Athens; Greece National Social Insurance Institute
• Investigators: Principal Investigator: Nicholas Tentolouris, MD, LAIKO General Hospital/University of Athens

Publications and helpful links

General Publications

• Tentolouris N, Lathouris P, Lontou S, Tzemos K, Maynard J. Screening for HbA1c-defined prediabetes and diabetes in an at-risk greek population: performance comparison of random capillary glucose, the ADA diabetes risk test and skin fluorescence spectroscopy. Diabetes Res Clin Pract. 2013 Apr;100(1):39-45. doi: 10.1016/j.diabres.2013.01.002. Epub 2013 Jan 28.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: April 3, 2012
• First Submitted That Met QC Criteria: April 5, 2012
• First Posted (Estimate): April 6, 2012

Study Record Updates

• Last Update Posted (Estimate): December 5, 2012
• Last Update Submitted That Met QC Criteria: December 3, 2012
• Last Verified: December 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: VL-MK01