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: 10786387
• 负责人: Farshad Tehrani
• 金额: $ 99.74万
• 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 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10786387
• 关键词: Discreet; Wearable; device; Continuous; Real

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.

抽象的 过量饮酒仍然是美国死亡和残疾的一个可预防的主要原因。 根据美国疾病控制与预防中心 (CDC) 的数据，平均 95,158 例酒精中毒 仅美国报告了死亡人数（每天 261 人死亡），相关年度费用为 2,490 亿美元。 该项目的目标是开发一款能够连续测量、记录、 实时存储 ISF 酒精浓度，无需进行外部校准。 酒精滥用和酒精中毒 (NIAAA) 正在寻求一种可连续监测的可穿戴酒精监测设备 测量血液或间质液（ISF）中的实时酒精含量，该提案与 NIAAA 的使命是准确的可穿戴酒精传感器将在不同的环境中发挥作用，包括 研究项目、诊所、法医应用和消费者使用，以促进负责任的饮酒 现有的透皮酒精监测设备依靠汗液或酒精检测。 汗水蒸气，面临重大问题，例如较长的滞后时间（长达几个小时）并且往往很麻烦。 在此背景下，ActioX, LLC 开发了一种非侵入式可穿戴传感器平台，以实现无痛分析 皮下几百微米，直接在 ISF 中，这种新颖的传感技术依赖于生物相容性。 微针阵列，针对无痛皮肤穿透进行了优化，从而提供持续的访问 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，以及定制的成功演示 我们使用原型设备设计了用于数据捕获和可视化的应用程序。 成功实时跟踪 ISF 酒精情况，以应对多个人类受试者的饮酒事件， 其结果与呼气分析仪的结果密切相关，该 SBIR 快速通道项目将利用这一点。 创新技术开发谨慎、实时、连续且免校准的连续酒精 长时间在体操作的监测设备，使临床更全面、更准确 研究并允许有效控制和管理与酒精相关的问题，包括酒精使用障碍。 第一阶段包括体外可行性研究，以找到具有最佳化学修饰策略的最佳化学修饰策略。 我们的目标是在第二阶段执行一系列的灵敏度、选择性、重现性和延长 3 天的稳定性。 临床研究开发一种前瞻性校准算法，可以实时转换原始数据 通过这项工作收集的电化学传感器信号将支持 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 可靠、准确的设备可供最终用户使用，包括医院、戒毒中心、戒毒所 测试实验室、政府部门等。