Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Validation of SCOUT DS algorithm, ROC performance equivalent to FPG, A1c for detection abnormal glucose tolerance. | 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. | 6 months |
Not provided
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Denver | Denver | Colorado | 80239 | United States |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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.