Precision nutrition is an emerging field that recognizes human physiological individuality and exploits it to procure dietary recommendations and/or interventions to improve oneâs 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 â a âlab-under- the-skin,â wherein a wide panel of nutrients and metabolites can be monitored using a miniaturized skin patch, thereby becoming a cornerstone of Precision Nutrition.
Public Health Relevance Statement: Precision nutrition offers a tremendous potential to enhance human health by providing dietary recommendations and/or interventions based on to individual-specific physiology. Wearable, continuous biochemical monitoring is poised to significantly progress the field of precision nutrition, which has been seen with recent studies utilizing commercially available CGM wearable devices. To further the filed, this SBIR Phase I proposal seeks to develop an integrated, miniaturized wearable device that can continuously and concurrently monitor a wider gamut of nutrients and/or metabolites via multiplexing.
Project Terms: Acceleration; Architecture; Engineering / Architecture; Chemistry; Chronic Disease; Chronic Illness; chronic disorder; Clinical Research; Clinical Study; Data Collection; Diet; diets; Electronics; electronic; electronic device; Engineering; Environment; Enzymes; Enzyme Gene; Feasibility Studies; Feedback; Glucose; D-Glucose; Dextrose; glucose oxidase; Microcid; Goals; Health; Health Status; Level of Health; Hormones; Endocrine Gland Secretion; Therapeutic Hormone; Human; Modern Man; Immobilization; orthopedic freezing; In Vitro; Individuality; Ionophores; Ketone Bodies; Ketones; Marketing; Metabolism; Intermediary Metabolism; Metabolic Processes; Methods; Microelectrodes; Miniaturized Electrodes; Needles; Noise; Oxidoreductase; Dehydrogenases; Oxidoreductase Gene; Reductases; Physiology; Potentiometry; Recommendation; Research; Signal Transduction; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Sodium; Na element; Technology; Time; Work; Measures; 3 Hydroxybutyrate; β-Hydroxybutyrate; beta-Hydroxybutyrate; customs; Custom; Interstitial Fluids; Intercellular Fluid; human subject; sensor; improved; Clinical; Phase; Variation; Variant; Physiologic; Physiological; Biochemical; Chemicals; Susceptibility; Predisposition; insight; Individual; Measurement; Metabolic; tool; Disease Management; Disorder Management; programs; Complex; Clinic; System; interest; innovative technologies; biomaterial compatibility; biocompatibility; interstitial; monitoring device; Performance; Nutrient; skin patch; novel; disorder prevention; disease prevention; Devices; performance tests; cross reactivity; miniaturize; miniaturized; Intervention; Intervention Strategies; interventional strategy; Pain Free; Skin; Dietary intake; fitness; Data; Detection; Diet and Nutrition; Measurable; National Institute of Diabetes and Digestive and Kidney Diseases; NIDDK; Reproducibility; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Nutritional; nutritious; Monitor; transmission process; Transmission; Process; Modification; Development; developmental; designing; design; Consumption; innovate; innovative; innovation; mobile device; handheld mobile device; prototype; multi-modality; multimodality; FDA approved; minimally invasive; bio-markers; biologic marker; biomarker; Biological Markers; risk mitigation; operations; operation; mobile app; mobile device application; mobile application; precision-based medicine; precision medicine; Android App; Android Application; Cell Phone Application; Cell phone App; Cellular Phone App; Cellular Phone Application; Smart Phone App; Smart Phone Application; Smartphone App; cell phone based app; iOS app; iOS application; iPhone App; iPhone Application; mobile phone app; smartphone based app; smartphone based application; smartphone application; Bluetooth; body sensor; body worn sensor; wearable biosensor; wearable sensor; wearable sensor technology; wearable electronics; wearable system; wearable technology; wearable tool; wearables; wearable device; Visualization; printed circuit board; dietary; individualized nutrition; precision nutrition; feasibility testing; wireless; wearable platform; miniaturized device; device miniaturization; miniaturized electronics; miniaturized technologies; wireless transmission; fabrication; Continuous Glucose Monitor; power con
