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

精确营养是一个识别人类生理个性并利用它来获得 饮食建议和/或干预措施，以改善健康和帮助预防疾病，以及 管理层。代谢谱，包括量化饮食摄入引起的生化变化，是 基本来电 破译饮食和健康状况之间的复杂联系，因此是一个关键的工具 以实现精准营养。最近，可穿戴式生化传感设备以方便的方式出现 方法连续和实时地监测这些化学变化，因此它们将显著 在这一领域取得进展。国家糖尿病、消化和肾脏疾病研究所(NIDDK)寻求一种SMART 可穿戴设备，用于持续监测循环或间质营养物质、代谢物或激素 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 能够连续和同时测量、存储和显示多个 与营养相关的分析物，包括钠、葡萄糖和酮，实时。钠、葡萄糖和酮 身体是整体健康和身体机能的基本指标，而连续和同时的 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、可用于连续监测多种分析物的商用设备。 在此背景下，ActioX LLC。开发了集成的无线操作可穿戴式传感器平台，基于 在生物兼容的微针阵列上，通过间质实现无痛连续分析生物化学物质 皮肤下只有几百微米的液体(ISF)。该SBIR第一阶段项目将利用这一创新技术 创造一种多路多模式可穿戴设备的技术，可以监测一组假定的营养物质 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。目标1建立体外可行性研究，以寻找最佳的化学修饰 具有最佳灵敏度、选择性、重复性和延长7天稳定性的策略，同时最大限度地减少交叉 不同传感器之间的反应性。AIM 2将涉及电子硬件设计和开发，以实现 同时进行安培和电位测量，以扩展可穿戴设备的检测能力 站台。在第一阶段成功完成后，第二阶段将专注于演示实用程序并建立 通过在人类受试者中进行广泛的临床研究，该多路传感器的可靠性。通过启用实时数据 同时收集钠、葡萄糖和酮，建议的可穿戴设备将服务于各种 环境，包括研究项目、诊所和消费者使用，以促进一般健康和健康。 从这项工作中获得的基础性见解将为实现我们的长期愿景-奠定基础 -皮肤，其中广泛的营养物质和代谢物可以使用微型皮肤贴片进行监测， 从而成为精准营养的基石。

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.