Discreet Wearable device for Continuous Real-time Monitoring of Alcohol

摘要 在美国，过度饮酒仍然是可预防的死亡和残疾的主要原因。 根据疾病控制和预防中心(CDC)的数据，平均有95,158人可归因于酒精 死亡(每天261例)仅在美国报告，相关的年成本为2490亿美元。 本项目的目标是开发一种可穿戴式集成设备，能够连续测量、记录 以及实时存储ISF酒精水平，无需外部校准。美国国家科学技术研究所 酒精滥用和酒精中毒(NIAAA)寻求一种可穿戴的酒精监测设备，可以连续 实时测量血液或间质液体(ISF)中的酒精水平，这一建议与 国家航空航天局的使命。准确的可穿戴式酒精传感器将在不同的环境下提供有用的服务，包括 研究项目、诊所、法医应用和消费者使用，以促进负责任的酒精 消费。现有的透皮酒精监测设备，依赖于汗液中的酒精检测或 汗蒸气，面临着严重的问题，如较长的滞后时间(长达几个小时)，并往往是笨拙的。 在此背景下，ActioX，LLC开发了一种非侵入性可穿戴传感器平台，以实现无痛分析 在皮肤下几百微米，直接进入ISF。新的传感技术依赖于一种生物兼容的 微针阵列，针对无痛皮肤穿透进行了优化，从而提供持续的 不断振兴ISF。这种完全集成的无线操作设备由两个组件组成， 可重复使用的电子设备和一次性微针阵列，以及一个定制的成功演示- 设计用于数据捕获和可视化的应用程序。我们使用原型装置的初步数据显示 在多个人类受试者中成功地实时跟踪响应饮酒事件的ISF酒精， 结果与酒精测定仪的结果有很好的相关性。该SBIR快速通道项目将利用这一点 创新技术，开发一种谨慎、实时、连续、无校准的连续酒精 用于延长体内手术时间的监控装置，使临床更全面、更准确 研究并有效控制和管理与酒精有关的问题，包括酒精使用障碍。 第一阶段包括体外可行性研究，以寻找最佳的化学修饰策略 灵敏度、选择性、重现性和延长的3天稳定性。我们的目标是在第二阶段执行一系列 临床研究以开发一种前瞻性校准算法，该算法可以实时转换原始数据 电化学传感器向BAC发出信号。通过这项工作收集的数据将支持FDA的批准，以及 随后，我们的实时、连续酒精监测可穿戴系统作为一种 可靠和准确的设备，可供最终用户使用，包括医院、戒毒康复中心、毒品 检测实验室、政府部门和其他机构。

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.