Evaluation of SCOUT DS Device in the Diagnosis of Diabetes Mellitus

NCT01572415 | Completed

• 1 other identifier: VL-MK01
• Study Type: observational
• Target: 409
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Type 2 Diabetes

Keywords

Screening for Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects must be 18 years of age or greater.

You may qualify if:

• Age greater than or equal to 45 years
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VeraLight, Inc.: lead
• Greece National Social Insurance Institute: collaborator
• Laikο General Hospital, Athens: collaborator

Study Sites (1)

Greece National Social Insurance Institute (IKA)

Athens, Greece

Location

Related Publications (1)

• 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.

  PMID: 23369230 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nicholas Tentolouris, MD

  LAIKO General Hospital/University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 6, 2012
• Study Start: September 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 5, 2012

Record last verified: 2012-12

Locations

GR (1)