The goal of this SBIR Phase I collaboration between EnLiSense LLC and UT Dallas is the development of a battery powered, wearable multiplexed alcohol biosensor platform (AWARE) for personal and lifestyle monitoring of alcohol consumption. The approach is to integrate EnLiSense's patent pending low power, high performance, impedance based flexible bioelectronics with Ethanol and Ethyl Glucuronide (EtG) sensors (i.e. CAIS) in ultra-low volumes (1?5 L) of perspired sweat. EtG is a stable metabolite of alcohol and are well expressed in body fluids including sweat. SAMHSA guidelines state EtG ? 1,000 ng/mL is indicative of heavy drinking on the same day or previous; and light drinking the same day [SMA12-4686]. Correlation studies have been done for Ethanol in blood to EtG in blood and urine [Hoiseth et al, 2007] and pharmacokinetics well established. Hence we will use a combinatorial approach for detecting in real-time and simultaneously Ethanol and EtG levels in perspired sweat towards quantitating blood alcohol levels. This SBIR Phase I project addresses the NIAAA mission to promote, direct, and support biomedical and behavioral research on the causes, consequences, treatment, and prevention of alcoholism and alcohol-related problems using a biosensor in the form of a refreshable strip (CAIS) on a wearable electronic bracelet that performs real-time continuous monitoring of alcohol consumption of the wearer towards making conscientious lifestyle decisions. This lightweight, unisex, and designer friendly wearable electronic bracelet will unobtrusively house the CAIS strips for real-time, multiplexed, and simultaneous monitoring of Ethanol and paired EtG levels in perspired sweat and also the components for data processing, storage, and wireless data transmission to a handheld device while operating on Li-ion batteries. Such trends in biomarker expressions in real-time will be used to quantitate against blood alcohol levels from standardized testing with our clinical consultants to establish behavioral patterns in alcohol consumption and lifestyle monitoring. Phase I will demonstrate simultaneous detection and quantification of paired Ethanol and EtG levels in real-time over a 24?96 hour continuous use period at relevant BAC levels varying from 0-0.5% representing abstinence to fatality. The prototype 1st generation AWARE platform with refreshable CAIS strips will have the ability to verify standardization at regular intervals and to indicate loss of functionality. The biosensors for specific detection of Ethanol and EtG will be integrated onto a refreshable patch and in direct contact with the skin sampling small volumes (1?5 L) of perspired sweat and reported wirelessly to a smartphone. Correlation and regression studies of sensor analytical performance using Passing?Bablok analysis and Brand?Altman analysis of the measurements from 1st generation AWARE sensor platform with the measurements from the lab instruments. Additional metabolite biomarkers, hydration, and heart rate sensors will be included following Phase I results and with the guidance from the clinical consultants to develop a robust, non-invasive, TAC paired with alcohol biomarkers analyzer that will be tested on clinical cohorts in Phase II.

Public Health Relevance

Alcohol abuse affects over 18.5 million adults in the U.S., costing society over $200 billion annually in lost productivity, health care expenses, motor vehicle accidents, crime and domestic violence. Alcohol related diseases contribute to more than 20 percent of all hospital admissions and approximate 100,000 deaths annually. It is envisioned that wearable alcohol consumption monitors will serve useful purposes in research, clinical, and treatment settings, play a role in public safety, and be of interest to individuals interested in keeping track of personal health parameters.

National Institute of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1)
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Dunty, Jr, William
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Enlisense, LLC
United States
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