Screening for Early Evidence of Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— SEED  

Official title:

A Prospective, Multi-Center, Paired Data, Cohort Screening Trial Comparing SCOUT to the Fasting Plasma Glucose Test in Subjects at Risk for Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00614783
• Other study ID #: VL-2701
• Status: Completed
• Phase: N/A
• First received: January 30, 2008
• Last updated: December 3, 2012
• Start date: May 2007
• Est. completion date: December 2010

Study information

• Verified date: December 2012
• Source: VeraLight, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This is a pivotal study to determine the accuracy of a new device (SCOUT) in screening persons for pre-diabetes or diabetes. SCOUT will be compared to the standard screening test (Fasting Plasma Glucose), using the Oral Glucose Tolerance Test as the reference standard.

SCOUT uses a rapid, noninvasive, light-based technology to measure the concentration of chemicals in the skin called advanced glycation endproducts (AGEs). Several studies have demonstrated that AGEs accumulate in skin faster in individuals with poor control of blood sugar.

Persons will be eligible for the study if they are 'at risk' for diabetes based on their age and other risk factors as defined by the American Diabetes Association.

Description:

Current methods for detecting pre-diabetes and diabetes are inconvenient and inaccurate. The most widely used screening test, Fasting Plasma Glucose (FPG), requires an overnight fast and a blood draw. FPG also has poor sensitivity contributing to late diagnoses. A more accurate and convenient screening method, like SCOUT, will improve early detection and allow the physician to begin a treatment regimen to prevent or delay the development of the disease and its serious complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3478
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• 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, with two or more of the following risk factors:

• Overweight (BMI = 25 kg/m2)

• Elevated waist circumference, >35 inches for women and >40 inches for men

• Habitually physically inactive

• Has a first-degree relative with diabetes

• African American, Latino, Native American, Asian American, Pacific Islander

• Delivered a baby weighing >9 lb or diagnosed with gestational diabetes

• Hypertension (>130/>85 mm Hg) or being treated for hypertension

• HDL cholesterol <35 mg/dL and/or triglycerides >250 mg/dL or being treated for dyslipidemia with medication

• Previously diagnosed with Polycystic Ovary Syndrome (PCOS)

• Abnormal Glucose Tolerance on previous testing within the last 3 years

• Has a condition associated with insulin resistance (e.g., acanthosis nigricans)

• History of vascular disease (e.g., heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure, or peripheral arterial disease)

Exclusion Criteria:

• Prior bariatric surgery

• Diagnosed with type 1 or 2 diabetes

• Taking glucose lowering medications

• Receiving dialysis or having known renal compromise

• Receiving investigational treatments

• Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm

• Recent or current oral steroid therapy or topical steroids applied to the left forearm

• Current chemotherapy, or chemotherapy within the past 12 months

• Conditions that cause secondary diabetes (e.g., Cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis)

• Receiving other investigational treatments

• Receiving drugs that fluoresce (e.g., Doxorubicin, Daunomycin, Camptothecin, Protoporphyrin, Fluoroquinolones, Tetracycline, Hydroxychloroquine or Quinidine)

• Known to be pregnant

• Psychosocial issues that interfere with an ability to follow study procedures

• 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, Type 2

Locations

Country	Name	City	State
United States	Lovelace Scientific Resources	Albuquerque	New Mexico
United States	Radiant Research	Chicago	Illinois
United States	Radiant Research	Cincinnati	Ohio
United States	Radiant Research	Edina	Minnesota
United States	New York Hospital Queens-Lang Research Center	Flushing	New York
United States	Kaiser Permanente-Center for Health Research	Honolulu	Hawaii
United States	Accelovance	Huntsville	Alabama
United States	Oklahoma Diabetes Center, University of Oklahoma	Oklahoma City	Oklahoma
United States	Radiant Research	Overland Park	Kansas
United States	Accelovance	Peoria	Illinois
United States	Diabetes and Lipid Research, University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Radiant Research	San Antonio	Texas
United States	Accelovance	San Diego	California
United States	Veteran's Administration Hospital	San Diego	California
United States	MedStar Research Institute	Washington, DC	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
VeraLight, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Produced SCOUT DS measurement algorithm.	Relative true positive and false positive fractions between Scout (Visit 2, nonfasting) and FPG (Visit 1, fasting) for detecting abnormal glucose tolerance, using the 2 hr OGTT = 140 mg/dL as the threshold for a positive result.	At completion of second visit which occurs within 1 to 14 days after the first visit.	No
Secondary	Secondary endpoints include the sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values of the Scout (Visit 2, nonfasting), FPG, and A1c tests for detection of abnormal glucose tolerance.		End of study	No
Secondary	Intra- and inter-day Scout test reproducibility.		End of study	No