Noninvasive Screening for Early Evidence of Diabetes With SCOUT DS - Full Text View

Purpose

The study will complete up to 500 subjects across 9 clinical sites to evaluate the precision and accuracy of SCOUT DS (Diabetes Screening) subjects at risk for type 2 diabetes. The study will involve up to two unique Scout devices at each clinical site. Each site will initially contain only a CS-1 (Commercial SCOUT 1) "A" for collection of data. As they become available, CS-1 "B"s operating with latest version of SCOUT software will be shipped to each site.

The NSEEDS study will enroll patients at-risk for type 2 diabetes who meet the study inclusion criteria (and do not meet one or more of the exclusion criteria) at approximately 9 clinical sites distributed across the United States. Eligible subjects must be at least 18 years old, not have an existing diagnosis of diabetes and, if less than 45 years old, must have a body mass index (BMI) ≥ 25 and at least one other risk factor for type 2 diabetes.

The data will be collected and a partial area under the receiver operator curve (pAUC) will be computed via the method of moments between the 20% and 50% false positive rates based on the first valid Scout "A" measurement for each patient. The impaired glucose tolerance status will be determined by the average of the two hour, post challenge plasma glucose samples measured at the central laboratory. This will be compared to 1000 bootstrap re-samplings of the calibration data pulling a cohort that matches that collected during this study. A test will be conducted to assure that the SCOUT performance lies within a 95% empirical confidence interval based on the bootstrap re-sampling.

Condition
Type 2 Diabetes


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Noninvasive Screening for Early Evidence of Diabetes With SCOUT DS

Further study details as provided by VeraLight, Inc.:

Primary Outcome Measures:

Validation of SCOUT DS algorithm, ROC performance equivalent to FPG, A1c for detection abnormal glucose tolerance. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The data will be collected and a partial area under the receiver operator curve (pAUC) will be computed via the method of moments between the 20% and 50% false positive rates based on the first valid Scout "A" measurement for each patient. The impaired glucose tolerance status will be determined by the average of the two hour, post challenge plasma glucose samples measured at the central laboratory. A test will be conducted to assure that the SCOUT performance lies within a 95% empirical confidence interval based on the bootstrap re-sampling.

Biospecimen Retention: Samples Without DNA

Serum will be stored to later analyze lipids and insulin. This will be useful in understanding metabolic disorders experienced by the patients measured. These measurements can be used directly, or combined in a manner similar to the McAuley index to understand the risk of insulin insensitivity.


Enrollment:	486
Study Start Date:	June 2011
Study Completion Date:	October 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
Those at Risk for Type 2 diabetes All subjects will be at risk for diabetes based on the American Diabetes Association (ADA) Standard of Care Guidelines.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

In the study, volunteers age 18 and above, of either sex and of any ethnic background, will be recruited at up to 9 clinical sites. The number of sites may be decreased as the sponsor has the right to close a site due to protocol compliance or enrollment issues during the course of the study. All subjects will be at risk for diabetes based on the American Diabetes Association Standard of Care Guidelines. Subjects in the 18-44 age range must have a BMI > 25 plus an additional risk factor for type 2 diabetes.

Criteria

Inclusion Criteria:

Age greater than or equal to 45 years;

OR
Age 18 to 44 years and a BMI > 25 with one or more of the following diabetes risk factors:
- Habitually physically inactive (less than 30 minutes of moderate physical activity most, if not all, days of the week)
- Has a first-degree relative with type 2 diabetes
- African American, Latino, Native American, Asian American, Pacific Islander
- Has delivered a baby weighing > 9 lb or previously diagnosed with gestational diabetes
- Hypertension (≥140/≥ 90 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 years
- Conditions associated with insulin resistance such as severe obesity or acanthosis nigricans
- History of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease

Exclusion Criteria:

Prior participation in VeraLight studies: VL-2701, VL-2710, VL-2711, VL-2712 , or VL-2718
Diagnosed with any type of diabetes, including type 1 or 2
Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
Receiving any investigational treatment 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
Taking glucose lowering medications*
Known to be pregnant (self reported)
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 *
Prior bariatric surgery

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: NCT01375686

Locations


United States, Colorado
Radiant Denver
Denver, Colorado, United States, 80239

Sponsors and Collaborators

VeraLight, Inc.

Investigators


Principal Investigator:	Michael Kyle, MD	Radiant Chicago
Principal Investigator:	Tami Helmer, MD	Radiant Minneapolis
Principal Investigator:	Michael Noss, MD	Radiant Cincinnati
Principal Investigator:	William Jennings, MD	Radiant San Antonio
Principal Investigator:	Daniel Brune, MD	Accelovance Peoria
Principal Investigator:	Martin L Kabongo, MD	Accelovance San Diego
Principal Investigator:	Earl Martin, MD	DM Clinical
Principal Investigator:	Audrey Lacour, MD	JUNO Research
Principal Investigator:	David Bolshoun, MD	Radiant Denver

More Information


Responsible Party:	VeraLight, Inc.
ClinicalTrials.gov Identifier:	NCT01375686 History of Changes
Other Study ID Numbers:	VL-2715
Study First Received:	June 15, 2011
Last Updated:	December 3, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by VeraLight, Inc.:


Diabetes

Additional relevant MeSH terms:


Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

ClinicalTrials.gov processed this record on September 27, 2016

Noninvasive Screening for Early Evidence of Diabetes With SCOUT DS (NSEEDS)