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NCT01375686 · ClinicalTrials.gov registry record
Noninvasive Screening for Early Evidence of Diabetes With SCOUT DS
A clinical trial, sponsored by VeraLight.
- Completed
- Registry status
- 486
- Enrollment target
NCT01375686: Completed study, sponsored by VeraLight.
NCT01375686 is a clinical trial that has completed, run by VeraLight. The registered enrollment target is 486 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01375686 has completed, sponsored by VeraLight.
- COMPLETED
- Registry status
- 486 participants
- Enrollment target
Study 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.
Primary Outcome
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 confide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 486 participants |
| Start Date | 2011-06 |
| Est. Completion | 2011-10 |
What the finished NCT01375686 record still lists
NCT01375686 is an observational study that tracks outcomes without assigning an intervention. The registered 486 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01375686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01375686 about?
NCT01375686 is a clinical study titled "Noninvasive Screening for Early Evidence of Diabetes With SCOUT DS". 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 (...
What is the current status of trial NCT01375686?
This trial is currently completed. The enrollment target is 486 participants. The study started on 2011-06. Estimated completion is 2011-10.
Who is sponsoring clinical trial NCT01375686?
This trial is sponsored by VeraLight, which has 10 total clinical trials registered on ClinicalTrials.gov.
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