Discreet Wearable device for Continuous Real-time Monitoring of Alcohol

用于连续实时监测酒精浓度的谨慎可穿戴设备

• 批准号: 10547664
• 负责人: Farshad Tehrani
• 金额: $ 38.43万
• 依托单位: ACTIOX LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10547664
• 关键词: Age; Alcohol consumption; Alcohols; Algorithms; Anodes; Bacterial Artificial Chromosomes; Biological Assay; Biosensing Techniques; Biosensor; Blood; Blood alcohol level measurement; Body measure procedure; Caliber; Calibration; Cause of Death; Centers for Disease Control and Prevention (U.S.); Cessation of life; Chemicals; Chemistry; Clinic; Clinical; Clinical Research; Coupled; Custom; Data; Data Display; Detection; Development; Devices; Dose; Drug Rehabilitation Centers; Economic Factors; Electronics; Enzymes; Ethnic group; Face; Feasibility Studies; Forensic Medicine; Gender; Goals; Government; Heavy Drinking; Hospitals; Hour; Human; Hydrogen Peroxide; Immobilization; In Vitro; Intercellular Fluid; Laboratories; Life; Measurement; Measures; Mechanics; Methods; Microinjections; Mission; Modification; Molds; National Institute on Alcohol Abuse and Alcoholism; Noise; Pain-Free; Painless; Penetration; Performance; Phase; Polymers; Population Heterogeneity; Race; Reporting; Reproducibility; Research; Secure; Series; Signal Transduction; Skin; Small Business Innovation Research Grant; Sterilization; Structure; System; Testing; Thick; Time; United States; Validation; Variant; Venous; Visualization; Work; World Health Organization; alcohol measurement; alcohol monitoring; alcohol oxidase; alcohol related problem; alcohol response; alcohol use disorder; attributable mortality; base; biomaterial compatibility; body sense; commercialization; cost; cytotoxicity; design; disability; drug testing; enzyme activity; feasibility testing; health economics; human subject; innovation; innovative technologies; interest; miniaturize; miniaturized device; mobile application; monitoring device; novel; operation; oxidation; printed circuit board; programs; prospective; prototype; public health relevance; real time monitoring; research clinical testing; response; sensor; sensor technology; trial design; vapor; wearable device; wearable sensor technology; wireless

Abstract 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.

摘要