Evaluation of SCOUT DS in Subjects With Type 2 Diabetes #2

NCT ID: NCT01346046

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

264 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Non-Insulin Dependent

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Those with Type 2 diabetes

270 subjects with Type 2 diabetes

No interventions assigned to this group

Non diabetic

30 healthy subjects

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VeraLight, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Walter Forman, MD

Role: PRINCIPAL_INVESTIGATOR

Lovelace Scientific Resources

Locations

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Albuquerque Convention Center

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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VL-2717

Identifier Type: -

Identifier Source: org_study_id