Clinical trial NCT01375686: Noninvasive Screening for Early Evidence of Diabetes With SCOUT DS
Official title: Noninvasive Screening for Early Evidence of Diabetes With SCOUT DS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Diabetes
Lead sponsor: VeraLight, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-17
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 45 years;

   OR
2. 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

Primary outcomes:
measure: Validation of SCOUT DS algorithm, ROC performance equivalent to FPG, A1c for detection abnormal glucose tolerance.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Radiant Denver
state: Colorado
Study officials:
affiliation: Radiant Chicago
name: Michael Kyle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Minneapolis
name: Tami Helmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Cincinnati
name: Michael Noss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant San Antonio
name: William Jennings, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Accelovance Peoria
name: Daniel Brune, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Accelovance San Diego
name: Martin L Kabongo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DM Clinical
name: Earl Martin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: JUNO Research
name: Audrey Lacour, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Denver
name: David Bolshoun, MD
role: PRINCIPAL_INVESTIGATOR
References: