Excessive alcohol use remains a leading preventable cause of death and disability in the United States. According to the Centers for Disease Control and Prevention (CDC), an average of 95,158 alcohol-attributable deaths (261 deaths per day) is reported only in the United States, with associated annual costs of $249 billion. The goal of this project is to develop a wearable integrated device capable of continuously measuring, recording, and storing ISF alcohol levels in real-time without the need for external calibrations. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks a wearable alcohol monitoring device that can continuously measure real-time alcohol levels in the blood or interstitial fluid (ISF), and this proposal is highly aligned with the NIAAA's mission. An accurate wearable alcohol sensor will serve useful purposes in different settings, including research programs, clinics, forensic applications, and consumer use to promote responsible alcohol consumption. The available transdermal alcohol monitoring devices, relying on alcohol detection in sweat or sweat vapor, face significant problems such as long lag times (up to several hours) and tend to be cumbersome. In this context, ActioX, LLC has developed a non-obtrusive wearable sensor platform to enable pain-free analysis few hundred microns under the skin, directly in the ISF. The novel sensing technology relies on a biocompatible array of microneedles, optimized for painless skin penetration, and thus to provide continuous access to constantly revitalizing ISF. This fully integrated wirelessly operated device is composed of two components of a reusable electronics and a disposable microneedle array, along with a successful demonstration of a custom- designed app for data capture and visualization. Our preliminary data using the prototype device showed successful real-time tracking of ISF alcohol in response to alcohol drinking episodes in multiple human subjects, with the results well correlated to those from a breathalyzer. This SBIR Fast-Track project will leverage this innovative technology to develop a discreet, real-time, continuous, and calibration-free continuous alcohol monitoring device toward prolonged on-body operations to enable more comprehensive and accurate clinical studies and allow efficient control and management of alcohol-related problems, including alcohol use disorder. Phase I constitutes in-vitro feasibility studies to find the best chemical modification strategy with optimal sensitivity, selectivity, reproducibility, and extended 3-days stability. We aim in Phase II to execute a series of clinical studies to develop a prospective calibration algorithm that can convert, in real time, the raw electrochemical sensor signals to BAC. The data gathered through this work will support FDA clearance, and subsequently, the commercialization of our real-time, continuous alcohol monitoring wearable system as a reliable and accurate device ready to be used by end users, including hospitals, drug rehabilitation centers, drug testing laboratories, government departments, and others.
Public Health Relevance Statement: Public Health Relevance Excessive alcohol use is a leading preventable cause of death and disability, with an average of 95,158 alcohol- attributable deaths in the United States each year. Despite the high demands for a wearable sensor that can continuously monitor alcohol consumption in real-time, current devices lack the desired workability. In this SBIR Fast-Track application, we propose further development of ActioX, LLC biosensor system, a discreet, non- obtrusive, and calibration-free wearable integrated device capable of continuously measuring alcohol consumption in real-time.
Project Terms: Age; ages; Alcohol consumption; Alcohol Drinking; EtOH drinking; EtOH use; alcohol ingestion; alcohol intake; alcohol product use; alcohol use; alcoholic beverage consumption; alcoholic drink intake; ethanol consumption; ethanol drinking; ethanol ingestion; ethanol intake; ethanol product use; ethanol use; alcohol use disorder; ethanol use disorder; Alcohols; Alcohol Chemical Class; Algorithms; Anodes; Biological Assay; Assay; Bioassay; Biologic Assays; Biosensing Techniques; Biosensing Technics; biosensing; Blood; Blood Reticuloendothelial System; Calibration; Cause of Death; Centers for Disease Control and Prevention (U.S.); CDC; Centers for Disease Control; Centers for Disease Control and Prevention; United States Centers for Disease Control; United States Centers for Disease Control and Prevention; Chemistry; Clinical Research; Clinical Study; Data Display; Cessation of life; Death; Electronics; electronic device; Enzymes; Enzyme Gene; Ethnic group; Ethnic People; Ethnic Population; Ethnic individual; Ethnicity People; Ethnicity Population; ethnicity group; Face; faces; facial; Feasibility Studies; Forensic Medicine; Forensics; Goals; Government; Hospitals; Human; Modern Man; Hydrogen Peroxide; H2O2; Hydroperoxide; Immobilization; orthopedic freezing; In Vitro; Laboratories; Methods; Microinjections; Mission; Noise; oxidation; Polymers; Racial Group; Racial Stocks; Race; Research; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Signal Transduction; Testing; Time; United States; Work; World Health Organization; alcohol oxidase; Gender; Measures; Population Heterogeneity; diverse populations; heterogeneous population; population diversity; Custom; Intercellular Fluid; Interstitial Fluids; base; human subject; sensor; alcohol measurement; ETOH level; alcohol level; ethanol measurement; ethyl alcohol measurements; Body measure procedure; Body Measures; Clinical; Penetration; Phase; Variant; Variation; Series; Economic Factors; Economical Factors; Chemicals; disability; non-painful; nonpainful; not painful; Painless; Measurement; enzyme activity; Venous; Filamentous Fungi; Molds; Life; programs; mechanical; Mechanics; Hour; Clinic; System; Blood Alcohol Content; blood alcohol concentration; blood alcohol level; Blood alcohol level measurement; interest; innovative technologies; biocompatibility; biomaterial compatibility; Lytotoxicity; cytotoxicity; monitoring device; Performance; vapor; body sense; biological sensor; Biosensor; Structure; novel; drink heavily; excessive alcohol consumption; excessive alcohol ingestion; excessive alcohol intake; excessive drinking; excessive ethanol ingestion; extreme drinking; heavy alcohol use; Heavy Drinking; Devices; Reporting; response; miniaturize; BAC clone; BACs; Bacterial Artificial Chromosomes; Pain-Free; Skin; Thickness; Thick; Diameter; Caliber; Dose; Drug Abuse Treatment Centers; Drug Treatment Centers; Drug Rehabilitation Centers; Data; Detection; Reproducibility; research clinical testing; Clinical Evaluation; Clinical Testing; clinical test; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Validation; Modification; Development; developmental; attributable mortality; attributable death; cost; health economics; design; designing; alcohol related problem; prospective; National Institute on Alcohol Abuse and Alcoholism; NIAAA; Coupled; innovation; innovate; innovative; drug testing; drug detection; alcohol monitoring; alcohol response; ethanol response; response to alcohol; response to ethanol; prototype; commercialization; public health relevance; Sterilization; Secure; operation; mobile application; mobile app; mobile device application; trial design; sensor technology; sensing technology; wearable sensor technology; body sensor; body worn sensor; wearable biosensor; wearable sensor; wearable system; wearable device; wearable electronics; wearable technology; real time monitoring; realtime monitoring; Visualization; printed circuit board; feasibility testing; wireless; miniaturized device; device miniaturization; miniaturized electronics; miniaturized technologies
