Smart solution for personalised health monitoring
While wearable fitness monitoring devices have become increasingly popular, these are typically unable to directly assess health status at the biomolecular level. The EU-funded ELSAH project wanted to address this, through developing a wearable ‘smart patch’. “The idea was that this ELSAH-patch would combine a microneedle-based biosensor with electronics, including a microchip, battery and antennas,” explains project coordinator Giorgio Mutinati from the AIT Austrian Institute of Technology. “This would enable the continuous monitoring of biomarkers such as glucose and lactate directly in intercellular dermal fluid.”
Expertise across several disciplines
To achieve these objectives, the ELSAH consortium brought together six research institutes, three SMEs and two large industry partners. “In this project, we had expertise in biosensing, chemistry, medical device design and manufacturing, electronics and medicine,” says Mutinati. “Our plan was to realise three generations of the ELSAH-patch system, with consecutively increasing integration levels.” The concept was to develop microneedles less than 1 mm in length, which would be painless to apply. Electronics would then deliver wireless data transmission to the user’s mobile phone. The first generation was a platform system assembled from interchangeable standard components. A key aim was to choose components that would be cheap to manufacture. In the second-generation system, these components were integrated, while the last generation delivered the final modular solution.
Successful biosensor demonstrations
Through this process, two ELSAH-patch demonstrators were developed and evaluated. The first was a technology demonstrator – code name Vienna – which integrated all components into a functional, non-clinical device, evaluated in the lab. Successful measurements of glucose and lactate were carried out on the sensor interface, and the measured data transferred to a laptop or mobile phone. The upload of the measured data was successfully tested. The second demonstrator – code name Graz – was a biosensor patch, used for first-in-human trials. “The Medical University of Graz in Austria performed the clinical study,” adds Mutinati. “This involved 30 healthy volunteers.” These trials demonstrated the system’s ability to record glucose and lactate values. In addition, feedback from study participants was consistently positive, particularly in terms of comfort and ease-of-use.
Supporting health and well-being
A number of important findings were made. For example, the project was able to confirm that lactazyme – a novel enzyme – is effective in lactate detection. The technology has since been protected by a patent application, and is currently being commercialised. Platinum was used instead of gold for the microneedles in order to reduce the environmental impact of the patch, while a highly versatile microchip was designed, fabricated and integrated. A software app for operating the patch was successfully developed. “Further technical development is still necessary to bring the ELSAH-patch to a higher technology readiness level,” notes Mutinati. “This includes a clinical study to validate and certify the patch as a medical device.” Once ready for market, Mutinati believes that this novel sensor will benefit numerous groups. These include individuals with chronic diseases undergoing physiotherapy, physiotherapists and doctors, athletes, and individuals looking to monitor their glucose levels. “It will be great when this painless smart patch becomes commercially available,” says Mutinati. “Our aim is that this product is affordable to everyone, to support health and well-being.”
Keywords
ELSAH, health, patch, monitoring, biomarker, biosensor, glucose, fitness
