Evaluation of SCOUT DS in Subjects With Type 2 Diabetes #2 (TCOYD2)

VeraLight

Status: Completed

Conditions: Diabetes Mellitus, Non-Insulin Dependent

Study type: Observational

Funder types: Industry

Identifiers

NCT01346046

VL-2717

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: 264 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age greater than or equal to 18 years Self-reported diagnosis of type 2 diabetes No Self-reported diagnosis of type 2 diabetes

Exclusion criteria

• Less than 18 years of age

  • 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

264 participants in 2 patient groups

Those with Type 2 diabetes

Description:

270 subjects with Type 2 diabetes

Non diabetic

Description:

30 healthy subjects