Non-invasive glucose monitoring for diabetics
Diabetes is a major global health concern, falling in the top 10 causes of death around the world. According to the IDF Diabetes Atlas, one in 10 adults have diabetes, while over a third are at a high risk of developing it in the future. Diagnosed diabetics must monitor their blood glucose levels consistently and accurately: in an ‘early’ phase of diabetes, periodically; at later – and more serious – stages, daily. Ideally, it should include multiple readings throughout the day. There are currently two methods: finger pricking, which is cumbersome and uncomfortable; or the use of continuous glucose monitors (CGMs), which are expensive and require a needle to be constantly inserted into the body of the user. As a result, most diabetics – and others who would benefit from glucose monitoring – don’t monitor their glucose levels as much as they should. As part of the EU-funded PREVENTDIABETES project, researchers developed a revolutionary technology able to detect glucose molecules through the skin. Diabetics can monitor their blood glucose levels in a non-invasive and comfortable manner, which could dramatically lift the levels of monitoring in the global population – and even prevent diabetes onset altogether. “A winning glucose monitor needs to be accurate, easy to use, small, affordable and needle-free,” says Jokke Mäki, managing director at GlucoModicum and PREVENTDIABETES project coordinator. “During the project, we optimised all these elements to create a small-size wearable device which is accurate, easy to use, small in size and manufacturable in very big volumes cost-effectively. This has not been trivial.”
Development of the non-invasive technology
Through the PREVENTDIABETES project, the GlucoModicum team further developed their patented medical device – the Talisman – to improve and enhance its capabilities. The Talisman uses proprietary magnetohydrodynamic (MHD) technology, which transports interstitial fluid (fluid in spaces around cells) to the surface of the skin. “By using this method, it is possible to get a high-quality sample non-invasively,” adds Mäki. “This is the foundation of all needle-free diagnostics, and has been the missing link in the diagnostics industry.” The Talisman CGM system includes two main elements: a durable device (transmitter) which can be used for two years and a consumable (daily) biosensor which reacts to the glucose molecules in interstitial fluid for testing. The team also developed electronics and algorithms needed to operate the system. The Talisman system can be worn on the arm, to constantly monitor blood glucose levels. A mobile app connects the device to the user’s phone, allowing data and insights to be uploaded securely into the cloud.
Testing the device in clinical studies
Mäki highlights that his team’s single biggest achievement from the project is the development of a device which showed, non-invasively, high correlation to blood glucose values in a broad clinical pilot study. The team plans to run further clinical studies to optimise the device performance, while at the same time preparing regulatory filings in the United States and Europe and developing high-volume manufacturing lines with capacity for tens of millions of units. They expect the first units to be shipped from these mass manufacturing lines within the next 12-15 months. “This is the first time in more than 25 years that a new platform technology has been introduced in this industry,” notes Mäki.
Keywords
PREVENTDIABETES, diabetes, monitoring, glucose, blood, non-invasive, clinical studies, prevent
