Innovative sensors to monitor body fluids
Fluids make up over half the human body. The exact amount varies between people, but each of us needs to maintain the right balance of fluids for our bodies to work properly. Taking in more than we can get rid of can lead to severe problems, especially for those at risk of dehydration or overhydration. Patients can suffer from comorbidities, such as injuries to kidneys, and at times fluid imbalances can be fatal. Yet the current methods for monitoring fluids are time-consuming and often inaccurate. “Assessing patient hydration accurately and reliably remains challenging due to the absence of a gold-standard method,” explains Martin Engebretsen, co-founder and chief marketing officer at Mode Sensors and ReBalans project coordinator. In clinical practice, healthcare providers often rely on a combination of methodologies, including blood tests, fluid balance charts (which track fluid intake and output), assessments of clinical symptoms (such as skin turgor), and weight monitoring. “These approaches, while comprehensive, are time-consuming and often fail to provide timely information,” says Engebretsen. “This delay in detecting changes in hydration status can prevent prompt intervention, leading to potentially avoidable health complications.” In the EU-funded ReBalans project, a team of researchers and developers at Mode Sensors have created the Re:Balans patch sensor, a wearable test for body hydration. The sensor is non-invasive and continuously monitors fluid levels, while automatically delivering patient data.
A wearable sensor for fluid monitoring
The Re:Balans system is a Bluetooth-connected sensor patch, which when placed on a patient’s skin gathers data from multiple integrated sensors. These include: a multi-frequency bioimpedance sensor, which picks up electrical activity in body tissue; an accelerometer, which measures movement and vibration; and thermistors, which detect temperature. “The patch is also equipped with proprietary, patent-protected algorithms,” adds Engebretsen. “These process the data from all these sensors to provide accurate and reliable hydration information.” An internet of things gateway hub is responsible for retrieving data from the sensor patch and securely transmitting it to patient monitoring systems, ensuring seamless and real-time data flow. Finally, an application is used to give a comprehensive and detailed overview of hydration status and other biomarkers for multiple patients, aggregating data to facilitate efficient and informed clinical decision-making.
Developing the technology and clinical testing
During the ReBalans project, the team made significant advancements in technology, enhancing the reliability of raw data collection, data processing and manufacturability. The project also conducted extensive clinical, safety and performance testing, both internally and with the assistance of clinical trial partners and accredited testing facilities. “All tests were successfully completed, and comprehensive documentation has been prepared to support regulatory approval submissions in both the United States and the EU,” notes Engebretsen.
Progressing towards a product launch
The project successfully created a mature product with demonstrated hydration monitoring performance, achieving ISO 13485 certification for safety and quality in the field of medical devices. The team have new patents pending protecting the technology, and have secured three commercial partnership agreements. A new pilot trial is planned for the last quarter of 2024, which aims to demonstrate the value and usability of Re:Balans in elderly care rehabilitation units. “If all goes to plan, the aim is to launch the product together with commercial partners in Europe and the United States during 2025,” says Engebretsen.
Keywords
ReBalans, body fluid, imbalance, elderly, care, wearable, sensor
