E! 114396 KWatch MULTI - Continuous biomarkers monitoring platform for efficient treatment of diabetes and other diseases

Smartwatches are going to revolutionise how diabetes and other patients are living with their disease. Going from painful, cumbersome, and expensive blood tests performed a few times a day, to painless and discrete continuous monitoring using a low-cost system, managing diabetes becomes safer, easier, cheaper, and less painful. Recent developments brought to the market novel Continuous Glucose Monitoring (CMG) devices, used by around 3% of diabetes patients under insulin, that can measure blood sugar levels from the fluid right under the skin (interstitial fluid). However, these devices have failed to achieve a fully non-invasive, trusted technique and hence result in low adherence among diabetes patients. To solve this, PKvitality has developed and marketed the K?Watch Glucose, a smart watch combined with a patch of minimally invasive and painless microneedles that provide diabetes patients with continuous measurement of glucose levels from the interstitial fluid. However, no solution today can measure several biomarkers that are important for diabetes monitoring, such as glucose + ketone, simultaneously.

We have demonstrated a ketone micro-needle sensor that can measure hydroxybutyrate (ketones) continuously in the physiologically relevant range for up to 12 days in vitro. We have proven continuous operation under simulated in vivo conditions, including artificial interstitial fluid, phantom skin, body temperature and interstitial fluid flow conditions. We have successfully integrated ketone in tandem with glucose on the same microneedle chip. The micro-needle platform has been demonstrated to work on a smart watch, reporting live to a smartphone app. We have filed a patent application for the fabrication method selectively depositing ketone recognition formula onto electrodes, thereamong micro-needles.

The goal of K'Watch MULTI is the development of a multianalyte platform in a smartwatch that integrates efficient and low cost measurement of different biomarkers combinations. The project is based on the already existing well-advanced technology of PKvitality’s first product: K’Watch Glucose. This product is composed of a watch and a patch, and continuously measures glucose level from the interstitial fluid using minimally invasive and painless microneedles ( <1mm). The main result of the K'WATCH MULTI project will be the development of a multianalyte monitoring solution in the form of a platform that will significantly reduce production costs of multianalytes. The project will keep the same product concept (K'Watch + patch), the same hardware and the same sensing architecture that makes the industrial and regulatory process easier and faster. During the project, the partners will adapt and improve the ketone detection technology, integrating it into K'Watch and collecting real-world data during clinical trials to achieve CE marking and FDA approval. In parallel with the market research work, they will identify other biomarker combinations that would be economically profitable and could provide related business models.