Being able to measure blood glucose levels without pricking a finger would improve the lives of millions of diabetic patients around the world. Not only would the pain go away, but patients would be more willing to check their sugar levels regularly, leading to better management of diabetes.
A group of Italian researchers based in Japan have been working on a device that uses light to estimate blood glucose concentration. They claim to have achieved a proof-of-concept that is accurate enough to continue toward product development. We’re naturally skeptical, so we spoke with Stefano Valenzi, the project leader, to find out more about how the Glucoscanner works, and what needs to be done before it turns into a product.
Medgadget: Non-invasive blood glucose measurement is one of the holy grails of medicine, frequently touted by researchers but that’s yet to come to market. Why is it so difficult to measure blood glucose without taking a blood sample?
Stefano Valenzi: Besides some general improvements that we brought to the optical method previously used by others, we are building on our research experience in acquisition and evaluation of bio-signals.
Medgadget: Please tell us some details about your technology and what led you to be able to measure glucose non-invasively that has alluded so many previous researchers?
Valenzi: This started as any other research project, we collected as much as we could about existing approaches, selected and tested anything we could. We have built a number of prototypes and used our experiences in designing data collection experiments. We also test extensively on ourselves or whoever wants to lend a hand.
We employ many light frequencies that are not standard, for instance near-infrared (NIR) LEDs. Therefore we had to patent our new technology and our new sensor module packages (and we are currently working with a big Japanese company to create these custom made module packages). Besides new and exclusive hardware, we have developed a new way to evaluate the tissue light absorption data. Further, another novelty is in the information used to estimate the glucose levels: we combine lights absorption info with other physiological and individual physical data. Our approach relies also on individual information, indeed; that helped us to solve some of the well known problem linked to optical technology, like differences in skin pigmentations.
To be successful our process requires a fast calibration and also the finger chosen for the calibration matters: e.g. once you calibrate the machine on your left hand thumb you have to keep using that finger.
However, it will be possible to repeat the calibration process in case it will be needed. A simple automated calibration procedure has been developed and the device will guide the user through the calibration process. For instance, Glucoscanner will evaluate which set of fingers the user should use to optimize the device performances.
Medgadget: Tell us about the accuracy of your technology? What have you done to verify it?
Valenzi: We have been conducting many studies during our Glucoscanner development. Data was analyzed between and within subject, and in many cases we collected thousands of measures. Eventually we started to employ external companies to recruit the necessary number of volunteers needed for our tests. However, to be able to provide final numbers we have to wait for a manufactured device. So far our tests have been conducted with prototypes assembled in our laboratories. The results are more than promising and very close, if not already overlapping, with over the counter glucometers used as reference. Further, we are confident that a manufactured device will perform even better than our current prototypes.
Medgadget: Do you have plans for full scale clinical studies?
Valenzi: Yes, we are currently planning and scheduling clinical trials in different hospitals around the world (so far in more than 10 countries). Our project has been welcomed by many medical doctors who share our common cause: help people to improve their glucose management and assist them in leading a healthier life.
We need hundreds devices with consistent performances to conduct the intended trials with standard clinical methods. This is the main reason to use manufacture devices: to get reliable data.
Fortunately that process is already on its way, and it will be soon achieved.
In the meantime, we are also planning to test our technology in application for the life quality improvements. We will package our sensor in a consumer device which will allow us to test our devices with as many people as possible.
Medgadget: Do you see specific use cases of your technology besides replacing to-go glucometers?
Valenzi: For sure it can be used for general lifestyle improvement purposes such as fitness, and diet. It cannot be excluded that integrating the glucose data with other information we will be able to provide other services.
Medgadget: Your organization seems to be mostly made of Italians living in Japan. What brought you together to push forward your technology?
Valenzi: The number of expats living in Tokyo is growing, but there is still a great chance for any two people with similar cultural or professional background will eventually meet. Some of us got connected because of common work or business interests. Three of us happened to have settled in Japan, have been living here for a decade or more. Pushing limits of technology and research was what two of us did for living and the reason why I and Peter came to and stayed in Japan. We aim to do this as long as possible, and having our own lab was one way to enable such a future. Knowing some people with experience in building businesses, our two other
core partners, made the switch from a research institute environment easier. Glucoscanner is just one of our projects, we hope to translate much more from our professional research experience into products in near
future. All of the partners are interested in building product which revolve around understanding of health, emotions or general well being of people and improving their lives.
Link: Glucoscanner info page…