ID-Cap System: Next generation ingestible sensors for medication adherence measurement

ID-Cap 系统：用于药物依从性测量的下一代可摄入传感器

基本信息

批准号：
10475453
负责人：
Tony Chris Carnes
金额：
$ 25.93万
依托单位：
ETECTRX, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-05-04 至 2024-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10475453
关键词：
Adherence Award Behavior Therapy Benchmarking Blood Caring Characteristics Chronic Chronic Disease Clinical Trials Collection Conduct Clinical Trials Data Development Devices Directly Observed Therapy Disease Dose Encapsulated Ensure Epidemic Event Feedback Funding Gelatin Gold Grant HIV HIV Infections HIV antiretroviral Hair Health Expenditures Health Personnel Healthcare Human Resources Individual Ingestion Investigation Investigator-Initiated Research Laboratories Link Measurement Measures Methods Miniaturization Monitor Morbidity - disease rate Opioid Opportunistic Infections Organizational Objectives Patient Self-Report Patients Pattern Performance Pharmaceutical Preparations Phase Pilot Projects Positioning Attribute Preparation Reader Records Regimen Research Research Project Grants Respondent Science Serum Signal Transduction Small Business Innovation Research Grant System Techniques Testing Time United States United States Food and Drug Administration United States National Institutes of Health Wrist acceptability and feasibility antiretroviral therapy base capsule cloud based commercialization comorbidity cost data ingestion design digital drug testing experience health organization improved innovation interest intervention delivery medication compliance medication nonadherence microchip miniaturize mortality next generation novel open label pill pilot trial pre-exposure prophylaxis prevent prototype radio frequency recruit response sensor smartphone Application success telepresence tool transmission process uptake usability wearable device

项目摘要

ABSTRACT Nonadherence to medication therapy results in significant morbidity and mortality across the world. In the United States, medication nonadherence results in $528 billion of annual costs to healthcare to manage consequences associated with nonadherence including progression of chronic disease. For medication regimens like HIV pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART), morbidity associated with nonadherence includes acquisition and transmission of HIV, opportunistic infections, and exacerbation of chronic HIV related comorbidities. In order to understand adherence and mitigate nonadherence, new direct adherence tools that confirm ingestion events are needed. Current indirect measures detect surrogate indicators of adherence like self-report, pill counting, or electronic adherence devices that detect the opening of pill bottles. These methods suffer from recall bias and often provide an incomplete measure of adherence. In contrast, direct measures, such as directly observed or video observed therapy that utilizes a clinician or healthcare worker to visually confirm medication ingestion, can verify medication ingestion events. Yet, these direct methods are expensive, require personnel, and are therefore difficult to scale. Direct confirmation of drug concentration in serum or hair may be used as evidence of medication adherence, but these methods require specialized analysis techniques and provide overall adherence which may overlook periods of suboptimal adherence. In response to the limitations of both indirect and direct measures of adherence, digital pills—an ingestible radiofrequency emitter and gelatin capsule which over encapsulates the desired medication— represent a tool that can directly confirm medication ingestions and innovatively provide feedback to both the user and care team. In 2019, etectRx received FDA 510K clearance for the ID-Cap, a digital pill system that directly measures medication adherence in real-time. Through K23DA044874 and independent investigator- initiated research grants from Gilead Sciences, we have demonstrated the feasibility of using the ID-Cap System among individuals to measure adherence to PrEP and opioids. During these investigations, we discovered widespread interest among patients in optimizing the system by developing a wrist-borne wearable Reader to collection adherence information from the digital pill. This Phase I SBIR therefore develops the next- generation ID-Cap System with a wrist-borne wearable reader. In Aim 1, we will miniaturize the current version of the Reader and conduct laboratory testing to ensure all components are functional and acquire signal from ingested digital pills. Next, in Aim 2, we will conduct an open-label pilot demonstration trial to understand the real-world usability of the next generation ID-Cap System among N=30 individuals on PrEP (N=15) and ART (N=15). Our benchmarks for success, the development of a miniaturized wrist-worn reader and demonstration of usability in a clinical trial, will optimally position us to advance commercialization efforts at etectRx in the context of a Phase II SBIR.

抽象的对药物治疗的不遵守会导致全世界的重要死亡率美国，医疗不遵守导致医疗保健的年度为5280亿美元与不依从性有关的后果，包括慢性疾病的进展与HIV预防前预防（PREP）和抗逆转录治疗（ART）等方案，与之相关的病态。不遵守包括艾滋病毒的收购和传播，机会性感染以及加剧慢性艾滋病毒相关的合并症。需要确认摄入事件的依从性工具。依从性的指标，例如自我报告，药丸计数或电子依从设备，以检测开口这些方法遭受了召回偏见，并且经常提供依从性对比，直接观察到的直接措施或使用临床医生或医疗保健工作者可以在视觉上确认药物摄入，可以验证药物摄入事件直接方法很昂贵，需要人员，因此很难直接确认药物。血清或头发的浓度可以用作鼻食药物的证据，但这些方法需要专业分析技术并提供总体依从性，这可能会忽略次优时期依从性。可摄入的射频发音仪和明胶胶囊，这些囊封装了所需的药物 - 代表一个直接确认药物摄入的药物，并创新地将其反馈给两者用户和护理团队在2019年。直接测量通过K23DA044874和独立研究者的药物依从性。我们从吉利德科学（Gilead Science）发起了研究赠款，我们已经证明了使用ID-CAP的备受推验个体之间的系统，以衡量对Pro PrEP和阿片类药物的依从性。通过开发腕带可穿戴状读者从数字药中收集依从性信息。带有腕带式读取器的ID-CAP系统。读取器和塑性测试的测试，以确保所有组件都具有功能并从中获取信号摄入的数字药。 N = 30个人在Prep（n = 15）和ART上的N = 30个人中的下一代ID-ap系统的现实世界可用性（n = 15）。在临床试验中的可用性，将最佳地定位我们在Etectrx上推进通讯范围 II期SBIR的上下文。