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

• 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
• 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

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.

摘要 不坚持药物治疗导致世界各地的发病率和死亡率显着。在 在美国，药物不依从导致每年5280亿美元的医疗保健成本 与不依从相关的后果，包括慢性疾病的进展。用药 艾滋病毒暴露前预防（PrEP）和抗逆转录病毒治疗（ART）等方案， 不依从包括获得和传播HIV、机会性感染和 慢性HIV相关合并症。为了了解依从性和减轻不依从性，新的直接 需要确认摄取事件的遵守工具。目前的间接措施检测替代品 坚持的指标，如自我报告，药丸计数，或电子坚持设备，检测开放的 药瓶这些方法存在回忆偏差，并且经常提供不完整的依从性测量。在 对比度、直接测量，例如利用临床医生或 医疗保健工作者视觉上确认药物摄取，可以验证药物摄取事件。然而这些 直接方法昂贵、需要人员，因此难以规模化。药物的直接确认 血清或毛发中的浓度可用作药物依从性的证据，但这些方法需要 专业的分析技术，并提供全面的遵守，这可能会忽略次优的时期 坚持。为了应对间接和直接测量依从性的局限性，数字药丸 可摄入的射频发射器和明胶胶囊，其包覆所需的药物， 代表一种工具，可以直接确认药物治疗，并创新地提供反馈， 用户和护理团队2019年，etectRx获得了ID-Cap的FDA 510 K许可，ID-Cap是一种数字药丸系统， 实时直接测量药物依从性。通过K23 DA 044874和独立研究者- 我们从吉利德科学公司获得了研究赠款，我们已经证明了使用ID-Cap的可行性 个人之间的系统，以衡量遵守PrEP和阿片类药物。在调查过程中，我们 通过开发一种腕戴式可穿戴设备， 阅读器从数字药丸中收集依从性信息。因此，第一阶段SBIR开发了下一个- 第二代ID帽系统与腕戴式可穿戴阅读器。在目标1中，我们将重新编译当前版本 并进行实验室测试，以确保所有组件功能正常并从 吃了数码药丸接下来，在目标2中，我们将进行一项开放标签试点示范试验，以了解 下一代ID-Cap系统在接受PrEP（N=15）和ART治疗的N=30名个体中的真实可用性 （N=15）。我们成功的基准，小型化腕戴式阅读器的开发和演示 在临床试验中的可用性，将使我们能够最佳地推进etectRx的商业化工作， 第二阶段SBIR的背景。