ENLISENSE LIMITED LIABILITY COMPANY — Department of Health and Human Services SBIR Phase I: 450

Description

Project Summary 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 EnLiSenseandapos 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 L of perspired sweat EtG is a stable metabolite of alcohol and are well expressed in body fluids including sweat SAMHSA guidelines state EtG ng mL is indicative of heavy drinking on the same day or previous and light drinking the same day SMA Correlation studies have been done for Ethanol in blood to EtG in blood and urine Hoiseth et al 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 hour continuous use period at relevant BAC levels varying from representing abstinence to fatality The prototype st 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 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 st 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 Project Narrative Alcohol abuse affects over million adults in the U S costing society over $ billion annually in lost productivity health care expenses motor vehicle accidents crime and domestic violence Alcohol related diseases contribute to more than percent of all hospital admissions and approximate 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