Therapeutic Monitoring System (TMS)

治疗监测系统（TMS）

• 批准号: 10786206
• 负责人: Patrik Schmidle
• 金额: $ 31.83万
• 依托单位: CARI HEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10786206
• 关键词: Achievement; Adherence; Adhesives; Appointment; Artificial skin; Behavior Therapy; Biological Assay; COVID-19 pandemic; Caring; Client satisfaction; Clinic; Clinic Visits; Clinical Research; Clinical Trials; Clothing; Commercial grade; Communities; Computer software; Continuous Glucose Monitor; Country; Custom; Data; Development; Devices; Dose; Dropout; Drops; Drug Prescriptions; Electronics; Emergency department visit; Feedback; Financial Hardship; Fright; Goals; Health; Health Personnel; Health Services Accessibility; Healthcare; Home; Human; Intercellular Fluid; Intervention; Interview; Low income; Marketing; Measures; Methadone; Methods; Modeling; Monitor; Needles; Occupations; Opioid; Overdose; Painless; Patients; Persons; Pharmaceutical Preparations; Phase; Physiologic pulse; Policies; Procedures; Process; Provider; Readiness; Relaxation; Reporting; Rural Population; Safety; Services; Signal Transduction; Small Business Innovation Research Grant; System; Technology; Testing; Therapeutic; Time; Transportation; United States Substance Abuse and Mental Health Services Administration; Update; Work; application programming interface; biomaterial compatibility; care providers; clinical practice; commercialization; data pipeline; drug misuse; experience; federal policy; flexibility; glucose monitor; improved; individualized medicine; innovation; manufacture; manufacturing process; manufacturing process development; medication compliance; medication for opioid use disorder; meetings; methadone treatment; miniaturized device; mobile application; mortality; opioid treatment program; opioid use disorder; power consumption; programs; prototype; remote monitoring; safety testing; sensor; sensor technology; skin organogenesis; social stigma; sterility testing; trustworthiness; usability; wearable device; wearable sensor technology

ABSTRACT More than half a million patients receive treatment at opioid treatment programs (OTPs) around the country, 95% of whom receive methadone as a medication for opioid use disorder (OUD), which is the gold standard for treating OUD. Current clinical practice for methadone medication treatment of OUD follows long-established federal and state regulatory policies that are highly restrictive and require patients to present in-person to a registered OTP every day to receive their prescribed methadone dose, creating an enormous obstacle to treatment that disproportionately impacts rural populations and low-income communities where lack of clinics, limited transportation, and/or inflexible jobs can make daily appointments difficult to sustain. This compliance burden contributes to program drop-out rates and adds to the public stigma surrounding OUD. States, OTPs, and other stakeholders have reported that a relaxation of federal policy during the COVID-19 pandemic, which allowed OTPs to prescribe longer take-home doses of medication to stable patients, had positive impact, resulting in increased treatment engagement, improved patient satisfaction with care, and few incidents of medication misuse. As a result, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) has proposed making the changes permanent. However, many care providers remain reluctant to prescribe the full amount of allowable take-home doses due, in part, to ingrained stigmas and fears regarding overdoses and diversion of medication. To help overcome provider reluctance and increase confidence in take-home medication compliance, this Fast-Track project proposes the development of an unobtrusive wearable biosensor device capable of detecting and remotely monitoring a patient’s taken doses of methadone to enable trustworthy take-home methadone treatment options that can expand access to OUD healthcare. The core of CARI Health’s remote medication monitoring (RMM) system is an electrochemical sensor that can detect and quantitate methadone and its metabolite EDDP in human interstitial fluid (ISF) using differential pulse voltammetry and a custom microneedle array. To date, CARI has successfully created and tested prototypes of the proposed sensor, microneedle array, and assay. This project proposes to integrate these components into a prototype device and develop an accompanying device data pipeline in Phase I (Aims 1-3), then develop a commercial grade product (Aim 4), at-scale manufacturing processes (Aim 5), and clear the CARI RMM for human wearable use (Aim 6) during Phase II to prepare for testing the CARI RMM in clinical studies (Aims 7, 8) It is expected that successful achievement of the above aims will facilitate FDA clearance of a de novo class II device and begin the commercialization process of the CARI Health monitoring system, a timely innovation that will help maximize the impact of SAMHSA’s efforts to update regulatory policies to meet the recognized needs of OUD patients.

摘要 全国超过50万的患者在阿片类药物治疗计划(OTP)中接受治疗，95%的患者接受治疗 其中接受美沙酮治疗阿片类药物使用障碍(OUD)的人，这是治疗 尽情款待。目前美沙酮治疗慢性阻塞性肺疾病的临床实践由来已久 联邦和州的监管政策具有高度的限制性，要求患者当面向 注册的OTP每天都要接受他们开出的美沙酮剂量，这给 对农村人口和缺乏诊所的低收入社区造成不成比例的影响的治疗， 有限的交通和/或缺乏弹性的工作可能会使日常约会难以维持。这一合规性 负担导致了课程辍学率，并增加了围绕大学的公众污名。州、OTP、 和其他利益攸关方报告称，新冠肺炎大流行期间联邦政策的放松， 允许OTP为病情稳定的患者开出更长的实得剂量的药物，产生了积极的影响， 结果增加了治疗参与度，提高了患者对护理的满意度，并减少了 滥用药物。因此，美国药物滥用和精神健康服务管理局 (SAMHSA)已提议将这些变化永久化。然而，许多护理提供者仍然不愿 开出允许带回家的全部剂量，部分原因是根深蒂固的耻辱和对 过量用药和转移用药。 为了帮助克服提供者的不情愿并增加对带回家的药物依从性的信心， 这个快速通道项目建议开发一种非侵入性的可穿戴生物传感器设备，能够 检测和远程监控患者服用的美沙酮剂量，以实现可靠的带回家 美沙酮治疗选择，可以扩大获得OUD医疗保健的机会。CAI Health遥控器的核心 药物监测系统(RMM)是一种检测和定量美沙酮的电化学传感器 差示脉冲伏安法测定人组织液中EDDP及其代谢物EDDP 微针阵列。到目前为止，CAI已经成功地创建并测试了拟议传感器的原型， 微针阵列和检测。该项目计划将这些组件集成到一个原型设备中，并 在第一阶段(目标1-3)开发配套的设备数据管道，然后开发商业级产品 (目标4)、规模化制造工艺(目标5)，并清除CAI RMM供人类穿戴(目标6) 在第二阶段，准备在临床研究中测试CAI RMM(AIMS 7，8) 预期上述目标的成功实现将有助于fda批准从头开始。 二类设备并开始CARI健康监测系统的商业化进程，适时 创新将有助于最大限度地发挥SAMHSA更新监管政策以满足 OUD患者认可的需求。