Evaluation of SCOUT DS in Subjects With Type 2 Diabetes

An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01346033

Acronym

TCOYD

Enrollment

270

Registered

2011-05-02

Start date

2010-10-31

Completion date

2010-10-31

Last updated

2012-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes, Adults 18 years and older, Taking Control of Your Diabetes Health Fair

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Validation of SCOUT DS algorithm for detecting known type 2 diabetes	1 day	Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes

Countries

United States

Outcome results