A Sensor Patch for Continuous Monitoring of Sodium, Glucose, and Ketones Concurrently and in Real-Time

用于同时实时连续监测钠、葡萄糖和酮的传感器贴片

• 批准号: 10761499
• 负责人: Farshad Tehrani
• 金额: $ 24.28万
• 依托单位: ACTIOX LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10761499
• 关键词: Acceleration; Architecture; Biochemical; Biological Markers; Bluetooth; Chemicals; Chemistry; Chronic Disease; Clinic; Clinical; Clinical Research; Complex; Consumption; Continuous Glucose Monitor; Custom; Data; Data Collection; Detection; Development; Devices; Diet; Diet and Nutrition; Dietary intake; Disease Management; Electronics; Engineering; Environment; Enzymes; FDA approved; Feasibility Studies; Feedback; Glucose; Goals; Health; Health Status; Hormones; Human; Immobilization; In Vitro; Individual; Individuality; Intercellular Fluid; Intervention; Ionophores; Ketone Bodies; Ketones; Marketing; Measurable; Measurement; Measures; Metabolic; Metabolism; Methods; Microelectrodes; Modification; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Needles; Noise; Nutrient; Nutritional; Oxidoreductase; Pain Free; Performance; Phase; Physiological; Physiology; Potentiometry; Predisposition; Process; Recommendation; Reproducibility; Research; Signal Transduction; Skin; Small Business Innovation Research Grant; Sodium; System; Technology; Time; Variant; Visualization; Work; beta-Hydroxybutyrate; biomaterial compatibility; cross reactivity; design; dietary; disorder prevention; fabrication; feasibility testing; fitness; glucose oxidase; handheld mobile device; human subject; improved; innovation; innovative technologies; insight; interest; interstitial; miniaturize; miniaturized device; minimally invasive; mobile application; monitoring device; multimodality; novel; operation; performance tests; power consumption; precision medicine; precision nutrition; printed circuit board; programs; prototype; risk mitigation; sensor; skin patch; smartphone application; tool; transmission process; wearable device; wearable platform; wearable sensor technology; wireless; wireless transmission

Precision nutrition is an emerging field that recognizes human physiological individuality and exploits it to procure dietary recommendations and/or interventions to improve one’s health and aid in disease prevention, and management. Metabolic profiling, which involves quantifying biochemical changes caused by dietary intake, is essential in deciphering the complex connection between diet and health status, and therefore is a critical tool to enable precision nutrition. Recently, wearable biochemical sensing devices have emerged as convenient method to monitor these chemical changes continuously and in real-time, and they are thus poised to significantly progress the field. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) seeks a smart wearable device for continuous monitoring of circulating or interstitial nutrients, metabolites, or hormones relevant to diet and nutrition. Accordingly, the goal of our proposed project is to develop a wearable device capable of continuously and simultaneously measuring, storing, and displaying interstitial levels of multiple nutritionally relevant analytes, including sodium, glucose, and ketone, in real time. Sodium, glucose, and ketone bodies are all essential indicators for overall health and bodily function, and the continuous and simultaneous monitoring of their levels within the body could offer invaluable clinically- and nutritionally- relevant information. To date, no FDA-cleared, commercially available device exists for the continuous monitoring of multiple analytes. In this context, ActioX LLC. has developed an integrated wirelessly operated wearable sensor platform, based on a biocompatible array of microneedles, to enable pain-free continuous analysis of biochemicals via interstitial fluid (ISF) just few hundred microns under the skin. This SBIR Phase I project will leverage this innovative technology to create a multiplexed and multimodal wearable device that can monitor a panel of putative nutrients for one week of continuous operation. To achieve this, readjustments will be performed at sensor, electronics, and smart phone app levels. Aim 1 constitutes in-vitro feasibility studies to find the best chemical modification strategy with optimal sensitivity, selectivity, reproducibility, and extended 7-days stability while minimizing cross- reactivity among different sensors. Aim 2 will involve electronic hardware design and development to enable concurrent amperometry and potentiometry measurements to expand the detection capabilities of the wearable platform. Upon successful completion of Phase I, Phase II will focus on demonstrating the utility and establishing reliability of the multiplexed sensor via extensive clinical studies in human subjects. By enabling real-time data collection of sodium, glucose, and ketone concurrently, the proposed wearable device will serve various environments, including research programs, clinics, and consumer use to promote general health and wellness. The foundational insights from this work will set the stage for accomplishing our long-term vision – a “lab-under- the-skin,” wherein a wide panel of nutrients and metabolites can be monitored using a miniaturized skin patch, thereby becoming a cornerstone of Precision Nutrition.

精准营养是一个新兴的领域，它认识到人类的生理个性，并利用它来获得 饮食建议和/或干预措施，以改善一个人的健康和帮助预防疾病，以及 管理代谢谱，包括量化饮食摄入引起的生化变化， 必不可少 破译饮食和健康状况之间的复杂联系，因此是一个重要的工具， 以实现精准营养。最近，可穿戴生化传感设备已经出现， 一种连续实时监测这些化学变化的方法，因此，它们有望显著提高 推进领域。国家糖尿病、消化和肾脏疾病研究所（NIDDK）寻求一种智能的 用于连续监测循环或间质营养物、代谢物或激素的可穿戴装置 与饮食和营养有关。因此，我们提出的项目的目标是开发一种可穿戴设备， 能够连续地和同时地测量、存储和显示多个 营养相关的分析物，包括钠、葡萄糖和酮，在真实的时间。钠、葡萄糖和酮 身体是整体健康和身体功能的重要指标， 监测它们在体内的水平可以提供宝贵的临床和营养相关信息。 到目前为止，还没有FDA批准的市售器械可用于连续监测多种分析物。 在这种情况下，ActioX LLC.开发了一个集成的无线操作的可穿戴传感器平台， 在生物相容性微针阵列上，通过组织间质内注射， 液体（ISF）在皮肤下只有几百微米。该SBIR第一阶段项目将利用这一创新 技术，以创建一个多路复用和多模式的可穿戴设备，可以监测一组假定的营养素 连续运行一周。为了实现这一点，将在传感器、电子设备、 和智能手机应用程序级别。目的1构成体外可行性研究，以找到最佳的化学修饰 具有最佳灵敏度、选择性、重现性和延长的7天稳定性，同时最大限度地减少交叉 不同传感器之间的反应。目标2将涉及电子硬件设计和开发， 同时进行电流分析和电位分析测量，以扩展可穿戴设备的检测能力。 平台在第一阶段成功完成后，第二阶段将重点展示实用程序，并建立 通过在人类受试者中进行的广泛临床研究，证实了多路复用传感器的可靠性。通过启用实时数据 同时收集钠、葡萄糖和酮，所提出的可穿戴设备将服务于各种 环境，包括研究计划，诊所和消费者使用，以促进一般健康和健康。 这项工作的基本见解将为实现我们的长期愿景奠定基础-一个“实验室下， “皮肤”，其中可以使用小型化皮肤贴片监测广泛的营养物质和代谢物， 从而成为精准营养的基石