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.
