Evaluation of SCOUT DS in Subjects With Type 2 Diabetes (TCOYD)

VeraLight

Status: Completed

Conditions: Type 2 Diabetes

Study type: Observational

Funder types: Industry

Identifiers

NCT01346033

VL-2714

Details and patient eligibility

About

The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes.

Full description

Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm.

Enrollment: 270 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age greater than or equal to 18 years
2. Self-reported diagnosis of type 2 diabetes

Exclusion criteria

• Not diagnosed with type 2 diabetes

  • Diagnosed with type 1 diabetes
  • 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.
  • Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

Trial design

270 participants in 1 patient group

Those with Type 2 diabetes

Description:

All subjects have been diagnosed with type 2 diabetes.