DiaMonTech GmbH, a young and innovative medical technology company based in Berlin, published remarkable results of a clinical study, confirming the accuracy of its non-invasive blood glucose-monitoring technology. In the clinical study, the blood glucose of 100 volunteers was measured using DiaMonTech's laser-based, non-invasive technology and compared to a clinically established invasive reference measurement method. The non-invasive method achieved measurement results with a mean error of only 11 percent, which is otherwise only achieved with (minimally-) invasive devices. The convincing results confirm DiaMonTech's plans to launch a product for diabetics for the non-invasive measurement of blood glucose on the market as early as next year.
"The successful completion of the clinical 'Study 100' is a decisive milestone on the way to the introduction of our portable product 'D-Pocket', which is to become a constant companion for diabetes patients. We achieved results on par with invasive devices. To our knowledge, there is no other non-invasive measurement method in the world that delivers comparable results. This puts us in competition with established blood glucose meters. For the first time the more than seven million diabetics in Germany can opt for a precise and completely pain-free alternative," says Thorsten Lubinski, Co-founder and CEO of DiaMonTech GmbH.
Professor Dr. Werner Mäntele, who has done research on infrared-based sensors for biotechnology and medical use for more than 20 years, is also one of the founders. The result of Professor Dr. Werner Mäntele's research is the patented, laser-based measurement method utilized successfully in DiaMonTech's products. With this, blood glucose can be measured precisely and painlessly without any stitching.
Prof. Dr. Werner Mäntele elaborates on the relevance of the study results: "In the study, blood glucose was measured every five minutes in each volunteer for two hours - both, with our technology and with an established invasive clinical reference measurement method."
A total of 59 healthy persons and 41 diabetics between the age of 18 to over 70 years participated in the study. The participants were asked to attend the measurement fasting, with a low blood glucose level. During the test period, blood glucose was increased with a glucose-containing drink for healthy volunteers. For diabetes patients, the usual increase in blood glucose after a meal was used. This ensured that measurement results were available for both, low and high blood glucose levels. DiaMonTech's non-invasive measurement delivered accurate measurements over the entire measuring range from about 50 mg/dL to over 350 mg/dL.
In the study, DiaMonTech's non-invasive glucose measurement yielded 99.1%* precise measurement results, demonstrating accuracy for men and women - both, healthy and diabetic - between 18 and over 70 years of age.
* The values result from a so-called "Consensus Error Grid Analysis", in which the measurement results of the DiaMonTech technology are compared with those of the simultaneously performed invasive measurement and divided into different zones (A-E). All measurement results in zones A and B meet the high accuracy requirements.
Founded in Berlin, Germany, in 2015, DiaMonTech is a medical technology company committed to improving health outcomes for people with diabetes and empowering them to take control of their lifelong health. Its pioneered and patented non-invasive “no prick” photothermal detection technology is fast and painless and doesn’t require needles or test strips. An industry first, DiaMonTech monitors the actual glucose molecules in skin, providing users with a more comprehensive and accurate reading comparable to invasive commercial devices. DiaMonTech achieved 99.1% accuracy in a test study with 100 people studied, received the CE mark as a medical device in April 2019 and is currently under FDA review. To support its mission, DiaMonTech is led by a world-class team of scientists, researchers and healthcare experts.
More information about DiaMonTech can be found at www.diamontech.de.