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Completed

NCT Number: NCT01346033

Evaluation of SCOUT DS in Subjects With Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Diego Convention Center

San Diego, California, 92111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater than or equal to 18 years
  • 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)

Treatment and study plan

Primary outcomes

  1. Validation of SCOUT DS algorithm for detecting known type 2 diabetes

    Time frame: 1 day

    Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes

Sponsors and collaborators

Lead sponsor

VeraLight, Inc.

Industry

Registry information

Official study title

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

Acronym: TCOYD

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 2, 2011
Registry last updated
Dec 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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