Noninvasive Screening for Early Evidence of Diabetes With SCOUT DS (NSEEDS)
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.
Type 2 Diabetes
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Noninvasive Screening for Early Evidence of Diabetes With SCOUT DS|
- 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.
|Study Start Date:||June 2011|
|Study Completion Date:||October 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375686
|United States, Colorado|
|Denver, Colorado, United States, 80239|
|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|