The purpose of this study is to evaluate the feasibility, usability, and performance of a wearable sensor patch designed to continuously monitor levels of glucose, sodium, and ketones in the body. Participants will be healthy, non-diabetic adults. Glucose, sodium, and ketones are important biomarkers for many diseases. A biomarker is a biological molecule found in blood, other body fluids, or tissues that may be a sign of a condition or disease and can be used to predict someone’s response to a specific treatment. The experimental patch in this study uses a minimally invasive microneedle technology to collect information without the need for repeated blood draws. The goal is to determine whether the device can accurately measure these health markers in real time. The glucose, ketone, and sodium measurements that participants provide will serve as a reference to check the accuracy of the data collected by the patch to see how well it is working. Study procedures include wearing the microneedle sensor, taking body measurements, checking vital signs, glucose and ketone monitoring, meetings with a dietician for diet plans, keeping a food log, blood draws, questionnaires, and keeping to a low-carb diet, then sodium-controlled diet supplemented with sodium tablets. Results of the study may help advance new ways for people to monitor their nutrition and health more easily.
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What is the full name of this clinical trial?
A sensor patch for continuous monitoring of sodium, glucose, and ketones concurrently and in real-time