Evaluation of a Novel Self-Sampling Earwax Tool for Chronic Disease Biomarkers [TREARS STUDIES II]

Plain-language summary

Trears Biomarkers: A New Way to Manage Chronic Diseases Trears Biomarkers are changing how we care for chronic diseases by focusing on patients' needs. People with chronic conditions often experience long-lasting changes in their bodies that typical tests do not accurately capture because they mostly measure short-term levels. These tests can be inconvenient, as patients frequently must travel to clinics, and some methods, like using needles, can be painful. The Trears device, on the other hand, is easy and safe for people to use at home. It lets patients take their earwax samples, which they can send to the lab by regular mail, avoiding the hassle of mailing blood samples. This device could even make diagnosing diabetes more accurate. Trears Biomarkers also investigates whether measuring sodium (salt) levels in earwax may be more reliable than a single blood pressure check and more straightforward than using a 24-hour blood pressure monitor. The aim is to enhance the diagnosis of all primary chronic conditions associated with Metabolic Syndrome (MetS), including diabetes, high cholesterol, obesity, and high blood pressure. These conditions are increasingly prevalent and already impact many people worldwide. With just one use, the Trears "multiplex" device could confirm a diagnosis typically requiring multiple tests. Long-term lifestyle changes, like a healthy diet and regular exercise, work better than many drugs for treating MetS. Since the Trears device measures levels that change over time, it can give doctors a better picture of what's happening in a patient's body, allowing for more personalised recommendations. For instance, providing specific dietary advice could be more effective than simply prescribing medication, as it may lead to more lasting improvements in weight and blood pressure. The device's design makes it accessible for home use, including by post, as earwax's natural bacteriostatic properties help preserve sample quality during mailing. In this study, we will test how effectively the Trears device works for diagnosing different types of diabetes and whether it can accurately track long-term levels of MetS markers. The device's new "multiplex" version might also support future point-of-care (POC) testing, allowing for the quick and convenient measurement of all MetS markers. We will consider how lifestyle factors - such as regular earplug use - might affect sample quality, ensuring the technology remains accurate and inclusive across diverse users. If necessary, we will introduce any potential changes in the Trears device design and/or marketing strategy after carefully considering feedback from our patients and their families, as outlined in Trears's mandate. Additionally, we will conduct an economic analysis to determine whether introducing the Trears device to a broader audience is financially sensible and essential. This will strengthen our position when launching our revolutionary technology in a conservative market.

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