Using SCOUT Noninvasive AGE Measurements to Forecast Diabetes Complications
Using SCOUT Noninvasive AGE Measurements to Forecast Diabetes Complications
The trial is designed as a feasibility study to determine the correlation of noninvasive
 measurements of AGE with the SCOUT device to diabetes complications.
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 million Americans (4.2%) had been diagnosed with some form of diabetes
 [1], and the World Health Organization (WHO) assessed the global diabetes caseload at 173
 million in the year 2000 [2]. While type 1 patients comprise approximately 5 -10% of the US
 cases [3], the severe morbidity in those patients including renal failure, blindness,
 neuropathy and micro- and macro-vascular disease motivate the search for improved techniques
 for monitoring disease status.

 Diabetes is devastating to individual health and has a significant impact on the national
 economy. In 2002, US economic impact related to diabetes exceeded $132 billion. Due to the
 numerous complications that result from chronic hyperglycemia a wide array of health services
 are involved. For example, between 5 and 20 percent of all US services in the areas of
 cardiovascular disease, kidney disease, endocrine and metabolic complications, and ophthalmic
 disorders are attributable to diabetes.

 Landmark clinical trials in the US and UK have established that tight glucose control via a
 regimen of glucose monitoring, insulin and/or sulfonylurea or other drug therapy, exercise,
 and proper diet significantly reduces the progression of, and risk for, developing diabetic
 complications [4, 5]. Long-term, chronic hyperglycemia is recognized as the initiator of
 debilitating diabetes-related complications such as blindness, kidney failure and nerve
 damage [6]. Hence, an effective monitor for overall glycemic control should reflect the
 long-term, integrated glycemic insult to the body.

 One concept of a monitor for long-term glycemic control involves the measurement of an
 analyte whose concentration monotonically increases over the course of disease progression.
 Such a chemical marker would not vary with the state in which the patient presented on the
 day of the test. The process of protein glycation (or 'browning'), governed by the Maillard
 reaction, produces several advanced glycation endproducts that are attractive candidates for
 such a 'diabetes meter.' These compounds are currently assayed by invasive procedures,
 requiring a biopsy specimen, but, based upon initial results with the VeraLight SCOUT, they
 are also accessible by noninvasive monitoring.
Inclusion Criteria:

 -  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 Criteria:

 -  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