Status:

COMPLETED

Using SCOUT Noninvasive AGE Measurements to Forecast Diabetes Complications

Lead Sponsor:

VeraLight, Inc.

Collaborating Sponsors:

Medstar Health Research Institute

Conditions:

Type 1 Diabetes

Type 2 Diabetes

Eligibility:

All Genders

18+ years

Brief Summary

The trial is designed as a feasibility study to determine the correlation of noninvasive measurements of AGE with the SCOUT device to diabetes complications.

Detailed Description

Diabetes mellitus is a major health problem in the United States and throughout the world's developed and developing nations. In 2002, the American Diabetes Association (ADA) has estimated that 12.1 m...

Eligibility Criteria

Inclusion

  • Potential subjects for the study will have type 1 or type 2 diabetes. Patients presenting for their periodic examinations at his practice will be given the opportunity to participate. Enrollment will conclude when the target of 250 subjects have been examined.

Exclusion

  • Wounds or injuries on the volar forearm in the field of view of SCOUT including blisters, cuts, scabs, cracked skin, tattoos and bleeding or oozing skin
  • Rash on forearm in field of SCOUT scan including eczema, psoriasis, shingles, rosacea, swimmer's itch, Christmas tree rash, lichen planus, contact dermatitus, ringworm, heat rash or drug rash
  • Receiving other investigational treatments
  • Receiving medications that may alter skin fluorescence/photosensitivity, including Doxorubicin, Daunomycin, Camptothecin, Protoporphyrin, Fluoroquinolones, Tetracycline and/or Quinidine
  • Known to be pregnant
  • Prisoner, mentally incompetent or unable to follow study procedures

Key Trial Info

Start Date :

March 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 1 2011

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT01415115

Start Date

March 1 2007

End Date

August 1 2011

Last Update

August 11 2011

Active Locations (1)

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Medstar Health Research Institute

Hyattsville, Maryland, United States, 20783