he Macedonian company Innovation has created a wireless device ECG Alert which, in addition to monitoring the work of the heart, also measures the level of blood sugar. The innovation, which is the only one of its kind in the world, has already been protected by two new patents filed with the World Intellectual Property Organization WIPO, and has been published in several scientific journals.
For the invention, which was developed with the support of the Fund for Innovation and Technological Development in the past two years, we talk with prof. Dr. Marjan Gushev, CEO of Innovation. He explained how this modern and non-invasive method will be of great benefit to both patients and medical systems.
Professor Gushev, explain to us what the Gluko project is and for whom it is intended?
Gluko is a project aimed at creating a medical device – a device that measures blood glucose levels with a wireless ECG sensor. It is worn on the body through patches and is a non-invasive method, which will replace glucose measurement methods with finger pricking, in which patients pay for each blood sugar measurement with a drop of blood. The device can be used by any patient at home, without the need to disrupt their daily activities. The same device measures the work of the heart and the level of glucose in the blood.
For the Gluko project, Innovation has partnered with the Innovation and Technological Development Fund as part of an instrument to improve innovation. The realization of Gluko started in October 2018 and ended at the end of last year.
How exactly does this non-invasive method of measuring blood sugar work?
The measurement is performed in such a way that the wireless sensor is attached to the body through two patches – electrodes and is worn for long-term measurement. The device sends a signal to the smartphone via a bluetooth connection, which shows the measurements and the results. The data is also sent to a cloud server on the Internet, where it is processed. That way, doctors or caregivers who carry the device and whose measurements need to be read can access the results very easily and at any time. They can use multiple tools for monitoring and reporting, and measurement results are widely available online.
The innovative method of measuring blood sugar follows another project of yours, the ECG Alert device. How did these two innovative projects connect?
In the period from 2017 to 2018, we realized a successful project with the Fund for Innovation and Technological Development in which we created a device for monitoring the work of the heart. During the preparation of that project, we came to several scientific findings, according to which we concluded that through the work of the heart we can monitor how the autonomic nervous system works, which is responsible for the regulation of blood glucose. In the process, we used new methods to calculate heart rate variability and several methods of artificial intelligence including machine learning and deep learning.
As a result, for the first time in the world, we created a prototype device for wireless measurement of glucose levels by measuring the work of the heart. The results of our research are protected by two new patents filed with the World Intellectual Property Organization WIPO, and six articles have been published in scientific journals with an impact factor and 16 articles in proceedings of international conferences.
What are your future plans related to the Gluko project?
Our goal is to finalize and commercialize the product, which requires large-scale demonstration and improvement according to user recommendations. The product will also need to be certified as a medical device in Europe and receive an appropriate quality and safety mark (CE Mark). Before we go on sale, it will have to be licensed in every European country.
It is certain that this process will take from one to two years, and additional funds are also needed. We believe that the business potential of Gluco is huge, given the large number of potential customers, which amounts to 5% of the general population, as well as the huge turnover of finances in the field of medical measuring instruments for measuring glucose and monitoring the work of the heart.