Evaluation of SCOUT DS Device in the Diagnosis of Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:

Evaluation of SCOUT DS Device in the Diagnosis of Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572415
• Other study ID #: VL-MK01
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: December 3, 2012
• Start date: September 2011
• Est. completion date: March 2012

Study information

• Verified date: December 2012
• Source: VeraLight, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

Country	Name	City	State
Greece	Greece National Social Insurance Institute (IKA)	Athens

Sponsors (3)

Lead Sponsor	Collaborator
VeraLight, Inc.	Greece National Social Insurance Institute, Laiko General Hospital of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No