Screening for Early Evidence of Diabetes - Full Text View

Sponsored by:	VeraLight, Inc.
Information provided by:	VeraLight, Inc.
ClinicalTrials.gov Identifier:	NCT00614783

Purpose

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.

Condition
Diabetes Mellitus, Type 2

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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

Further study details as provided by VeraLight, Inc.:

Primary Outcome Measures:

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. [ Time Frame: At completion of second visit which occurs within 1 to 14 days after the first visit. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: End of study ] [ Designated as safety issue: No ]
Intra- and inter-day Scout test reproducibility. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	9000
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Detailed 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.

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

General population who are 'at risk' for pre-diabetes or diabetes.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614783

Locations

United States, Alabama
Accelovance	Recruiting
Huntsville, Alabama, United States, 35802
Contact: Sudi Rasooli 256-883-5635 srasooli@accelovance.com
Principal Investigator: Randle Middleton, MD
United States, California
Veteran's Administration Hospital	Recruiting
San Diego, California, United States, 92161
Contact: Catherine Delue 858-552-8585 ext 6740 catherine.delue@va.gov
Principal Investigator: Edward Chao, DO
Accelovance	Recruiting
San Diego, California, United States, 92108
Contact: Violeta Matsuda, CCRC 619-291-2802
Principal Investigator: Martin Kabongo, MD
United States, District of Columbia
MedStar Research Institute	Recruiting
Washington, DC, District of Columbia, United States, 20003
Contact: Recruiting Number 202-787-5373
Principal Investigator: Vanita Aroda, MD
United States, Hawaii
Kaiser Permanente-Center for Health Research	Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Cyndee Yonehara 808-423-4759
Principal Investigator: Teresa Hillier, MD
United States, Illinois
Accelovance	Recruiting
Peoria, Illinois, United States, 61602
Contact: Maggie Larson 309-672-1910 ext 104 mlarson@accelovance.com
Principal Investigator: Daniel H Brune, MD
Radiant Research	Recruiting
Chicago, Illinois, United States, 60610
Contact: Call Center 800-494-2227
Principal Investigator: Jeffrey Geohas, MD
United States, Kansas
Radiant Research	Recruiting
Overland Park, Kansas, United States, 66202
Contact: Call Center 913-599-5656
Principal Investigator: Carlos Petit, MD
United States, Minnesota
Radiant Research	Recruiting
Edina, Minnesota, United States, 55435
Contact: Call Center 952-848-2065
Principal Investigator: Sheila Rodstein, MD
United States, New Mexico
Lovelace Scientific Resources	Recruiting
Albuquerque, New Mexico, United States, 87108
Contact: Jeanie Tovrea, MSN, RN, CCRC 505-348-8546
Principal Investigator: Martin Conway, MD
United States, New York
New York Hospital Queens-Lang Research Center	Recruiting
Flushing, New York, United States, 11355
Contact: Susan Ingenito, CMA 718-661-7859
Principal Investigator: Daniel Lorber, MD
United States, Ohio
Radiant Research	Recruiting
Cincinnati, Ohio, United States, 45249
Contact: Call Center 800-949-8295
Principal Investigator: Michael Noss, MD
United States, Oklahoma
Oklahoma Diabetes Center, University of Oklahoma	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Sean G Duguay, BS 405-271-3369 Sean-duguay@ouhsc.edu
Contact: Sharon Buckley, RN, CDE 405-271-3369
Principal Investigator: Timothy J Lyons, MD
United States, Pennsylvania
Diabetes and Lipid Research, University of Pittsburgh	Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Georgia Pambianco 412-383-1275 glp@pitt.edu
Contact: Nancy Silvers 412-383-1049 nsedic@pitt.edu
Principal Investigator: Trevor Orchard, MD
United States, Texas
Radiant Research	Recruiting
San Antonio, Texas, United States, 78229
Contact: Call Center 210-616-0735
Principal Investigator: William Jennings, MD

Sponsors and Collaborators

VeraLight, Inc.

Investigators

Study Director:

John Maynard, MS

Sr. Vice President, Product Development, VeraLight Inc.

More Information

Responsible Party:	VeraLight, Inc. ( Richard G. Hunter, Director, Clinical and Regulatory Affairs )
Study ID Numbers:	VL-2701
Study First Received:	January 30, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00614783
Health Authority:	United States: Institutional Review Board

Keywords provided by VeraLight, Inc.:

Screening

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009