(Applicant?s abstract): RGMT?s long-term objective is to develop a low-cost, handheld, rugged, field-deployable noninvasive alcohol measurement system for law enforcement, workplace, research, and clinical settings. The system will optimize, for EtOH, an optical spectroscopy technology platform developed to non-invasively measure glucose levels. Initial experiments measuring alcohol demonstrate accuracy levels that exceed breathalyzers in blood alcohol content correlations. This Phase I study has three, field-relevant research objectives: prove the system can distinguish topical interferents from ingested EtOH; demonstrate the correlation between capillary blood alcohol and tissue compartment kinetics; and, demonstrate system accuracy better than a BAC of 0.01. This document details the research program, the role and care of human subjects participating in the study, and briefly describes the Phase II field study, and the Phase III commercialization strategy. Included in the documentation is a commercialization commitment contingent on Phase I and II success. A simple method to measure alcohol levels non-invasively would minimize healthcare practitioner and law enforcement personnel exposure to breath and body fluids. Optional identity verification capability may ensure that the person tested is the same person participating in a treatment program, is the person enrolled in a punitive program, or was the same person tested at an earlier date.
