Periodic Reporting for period 1 - KERMIT (Kidney Disease Sweat sensor patch for Early diagnosis and Remote MonIToring)
Okres sprawozdawczy: 2023-07-01 do 2024-06-30
Chronic kidney disease (CKD) and acute kidney injury (AKI) are significant global health concerns, affecting millions of people worldwide. These conditions are often diagnosed late, resulting in high morbidity and mortality rates, as well as placing a substantial burden on healthcare systems. Traditional methods for monitoring kidney function rely on invasive blood tests and urine analysis, which are not only uncomfortable for patients but also require frequent hospital visits, making continuous monitoring challenging. There is an urgent need for innovative solutions that enable non-invasive, real-time monitoring of kidney health, particularly for high-risk populations such as the elderly, diabetics, and those with cardiovascular conditions.
The KERMIT project aims to address these challenges by developing a fully integrated, non-invasive point-of-care (PoC) device capable of continuously monitoring key kidney function biomarkers—urea, creatinine, and cystatin C—in sweat. By leveraging advances in microfluidics, printed electronics, and wireless communication, the project seeks to create a wearable patch that can provide real-time data on kidney health, thereby enabling early diagnosis, proactive treatment, and better disease management. This approach has the potential to significantly reduce the burden on healthcare systems, lower treatment costs, and improve the quality of life for patients by minimizing the need for hospital visits and invasive tests.
The project’s main objectives are to:
1. Create a reference base for remote diagnosis by correlating sweat biomarkers with those in blood, enabling accurate, non-invasive monitoring of CKD and AKI.
2. Develop reliable electrochemical sensing mechanisms for detecting kidney disease biomarkers with high sensitivity and specificity, minimizing false positives through multi-analyte detection.
3. Produce a versatile, wireless skin patch that integrates sensors, a low-power analysis chip, and wireless data transmission to enable seamless integration into patients' daily lives.
The KERMIT patch will integrate sensing, energy storage, communication, and microfluidic modules on biocompatible substrates, ensuring reliable operation under real-world conditions. The project also aims to involve patients and healthcare professionals throughout the development process to ensure the device meets practical needs and user expectations. The expected impacts include not only improved patient outcomes and reduced healthcare costs but also contributions to a more sustainable healthcare model by minimizing medical waste and the carbon footprint associated with traditional diagnostic methods.
The KERMIT project aims to address these challenges by developing a fully integrated, non-invasive point-of-care (PoC) device capable of continuously monitoring key kidney function biomarkers—urea, creatinine, and cystatin C—in sweat. By leveraging advances in microfluidics, printed electronics, and wireless communication, the project seeks to create a wearable patch that can provide real-time data on kidney health, thereby enabling early diagnosis, proactive treatment, and better disease management. This approach has the potential to significantly reduce the burden on healthcare systems, lower treatment costs, and improve the quality of life for patients by minimizing the need for hospital visits and invasive tests.
The project’s main objectives are to:
1. Create a reference base for remote diagnosis by correlating sweat biomarkers with those in blood, enabling accurate, non-invasive monitoring of CKD and AKI.
2. Develop reliable electrochemical sensing mechanisms for detecting kidney disease biomarkers with high sensitivity and specificity, minimizing false positives through multi-analyte detection.
3. Produce a versatile, wireless skin patch that integrates sensors, a low-power analysis chip, and wireless data transmission to enable seamless integration into patients' daily lives.
The KERMIT patch will integrate sensing, energy storage, communication, and microfluidic modules on biocompatible substrates, ensuring reliable operation under real-world conditions. The project also aims to involve patients and healthcare professionals throughout the development process to ensure the device meets practical needs and user expectations. The expected impacts include not only improved patient outcomes and reduced healthcare costs but also contributions to a more sustainable healthcare model by minimizing medical waste and the carbon footprint associated with traditional diagnostic methods.
During this reporting period, the KERMIT project achieved significant milestones across several key areas, advancing its goal of developing a non-invasive monitoring solution for kidney health.
In sensor development, we refined the functionalization layers for detecting critical kidney biomarkers: cystatin-C, creatinine, and urea. We made progress in detecting cystatin-C using 2D materials and in non-enzymatic detection of urea, improving sensor stability and reliability. An analytical protocol for determining CKD biomarkers was developed, addressing sampling, storage, and biomarker analysis. This work established a foundation for correlating blood and sweat biomarkers.
The microchip development high-frequency electrochemical impedance spectroscopy (EIS). This capability allows the chip to perform precise and sequential measurements of up to six biomarkers, using different electrochemical techniques.
Additionally, the fabrication parameters for printing different functional inks were optimized to produce the layers of the sensors, battery, and the electrodes that are embedded in the microfluidic system. By performing ink formulation with advanced materials like conductive polymers and flakes of 2D materials, we seek to replicate the response of gold-based sensors. Efforts in the microfluidic device fabrication has focused on optimizing the patterning parameters and the material selection to improve the scalability and enhance the compatibility to reduce molecular absorption, while the solid-state electrolytes of Zinc based batteries were optimized to meet the energy demand of the chip and the iontophoresis system.
Lastly, Initial questionnaires were created to gather feedback from patients during the clinical trial phase, which will help refine the device to better meet user needs and expectations. This feedback will be crucial in shaping the design and user experience, ensuring that the final product is not only functional but also comfortable and easy to use for patients in their daily lives.
In sensor development, we refined the functionalization layers for detecting critical kidney biomarkers: cystatin-C, creatinine, and urea. We made progress in detecting cystatin-C using 2D materials and in non-enzymatic detection of urea, improving sensor stability and reliability. An analytical protocol for determining CKD biomarkers was developed, addressing sampling, storage, and biomarker analysis. This work established a foundation for correlating blood and sweat biomarkers.
The microchip development high-frequency electrochemical impedance spectroscopy (EIS). This capability allows the chip to perform precise and sequential measurements of up to six biomarkers, using different electrochemical techniques.
Additionally, the fabrication parameters for printing different functional inks were optimized to produce the layers of the sensors, battery, and the electrodes that are embedded in the microfluidic system. By performing ink formulation with advanced materials like conductive polymers and flakes of 2D materials, we seek to replicate the response of gold-based sensors. Efforts in the microfluidic device fabrication has focused on optimizing the patterning parameters and the material selection to improve the scalability and enhance the compatibility to reduce molecular absorption, while the solid-state electrolytes of Zinc based batteries were optimized to meet the energy demand of the chip and the iontophoresis system.
Lastly, Initial questionnaires were created to gather feedback from patients during the clinical trial phase, which will help refine the device to better meet user needs and expectations. This feedback will be crucial in shaping the design and user experience, ensuring that the final product is not only functional but also comfortable and easy to use for patients in their daily lives.
Sensor technologies: Detecting cystatin-C in sweat is groundbreaking, as no sensors for this biomarker currently exist. The KERMIT project is using conductive polymers, 2D nanomaterials, and functionalization techniques, to enhance sensor sensitivity and stability while enabling low-cost, flexible production for wearable devices.
Microchip Development: The KERMIT microchip integrates multiple electrochemical measurement techniques ( high-frequency EIS with voltammetry and amperometry) and features (NFC communication and energy harvesting) in a compact, low-power single device, eliminating the need for external electronic components.
Sustainable Microfluidics: The microfluidic system is designed to collect sweat and channel it to sensors for biomarker detection, using biodegradable, biocompatible materials to ensure sustainability.
Potential Impacts: The printed sensors developed by KERMIT could significantly improve CKD monitoring by offering a non-invasive, continuous tracking method directly from sweat, providing a more patient-friendly alternative to invasive blood tests. The microchip’s ability to perform multiplexed measurements in a compact, low-power device enhances diagnostic precision and patient convenience, with broader applications in wearable health technology. The sustainable microfluidic system addresses the environmental concerns associated with single-use medical devices, reducing their ecological footprint through the use of biodegradable materials.
Research needs: Refine sensor functionalization for longevity and stability, optimize microfluidic design, and validate technologies in clinical settings.
Market Access and Commercialization: Form partnerships with manufacturers and healthcare providers, and secure funding for large-scale production.
IP Protection and Regulatory Compliance: Protect intellectual property and navigate regulatory standards, especially for sustainable materials.
International Collaboration: Collaborate globally to adapt technologies to different markets and enhance credibility through sustainability initiatives.
Microchip Development: The KERMIT microchip integrates multiple electrochemical measurement techniques ( high-frequency EIS with voltammetry and amperometry) and features (NFC communication and energy harvesting) in a compact, low-power single device, eliminating the need for external electronic components.
Sustainable Microfluidics: The microfluidic system is designed to collect sweat and channel it to sensors for biomarker detection, using biodegradable, biocompatible materials to ensure sustainability.
Potential Impacts: The printed sensors developed by KERMIT could significantly improve CKD monitoring by offering a non-invasive, continuous tracking method directly from sweat, providing a more patient-friendly alternative to invasive blood tests. The microchip’s ability to perform multiplexed measurements in a compact, low-power device enhances diagnostic precision and patient convenience, with broader applications in wearable health technology. The sustainable microfluidic system addresses the environmental concerns associated with single-use medical devices, reducing their ecological footprint through the use of biodegradable materials.
Research needs: Refine sensor functionalization for longevity and stability, optimize microfluidic design, and validate technologies in clinical settings.
Market Access and Commercialization: Form partnerships with manufacturers and healthcare providers, and secure funding for large-scale production.
IP Protection and Regulatory Compliance: Protect intellectual property and navigate regulatory standards, especially for sustainable materials.
International Collaboration: Collaborate globally to adapt technologies to different markets and enhance credibility through sustainability initiatives.