Evaluation of SCOUT DS Device in the Diagnosis of Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborators:
Greece National Social Insurance Institute
Laiko General Hospital of Athens
Information provided by (Responsible Party):
VeraLight, Inc.
ClinicalTrials.gov Identifier:
NCT01572415
First received: April 3, 2012
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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%.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of SCOUT DS Device in the Diagnosis of Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by VeraLight, Inc.:

Primary Outcome Measures:
  • Comparison of SCOUT DS to Random Capillary Glucose [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 409
Study Start Date: September 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects must be 18 years of age or greater.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572415

Locations
Greece
Greece National Social Insurance Institute (IKA)
Athens, Greece
Sponsors and Collaborators
VeraLight, Inc.
Greece National Social Insurance Institute
Laiko General Hospital of Athens
Investigators
Principal Investigator: Nicholas Tentolouris, MD LAIKO General Hospital/University of Athens
  More Information

No publications provided by VeraLight, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VeraLight, Inc.
ClinicalTrials.gov Identifier: NCT01572415     History of Changes
Other Study ID Numbers: VL-MK01
Study First Received: April 3, 2012
Last Updated: December 3, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by VeraLight, Inc.:
Screening for Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014