The results of the study confirm the accuracy and precision of DiaMonTech's patented diagnostic technology.
Within the clinical study, the blood glucose of 100 volunteers was measured with the laser-based, non-invasive technology and compared in parallel with an invasive reference method. The non-invasive method of DiaMonTech achieved measurement results with a mean absolute relative deviation of only 11.1% and is therefore on an accuracy level with (minimal-)invasive devices already on the market.
To the knowledge of the company, no other non-invasive measurement method globally has been so far able to provide such comparable good results.
"The publication of our clinical study in a world-leading peer-reviewed diabetes journal is a special recognition of our work. According to the highest scientific standards, we have achieved results with our non-invasive measurement method for blood glucose that can compete with invasive and minimally invasive devices.
This is a milestone on the way to theintroduction of our portable product "D-Pocket", which is intended to become a constant companion for diabetes patients and prediabetics. For the first time they can choose an accurate, precise and painless alternative", says Thorsten Lubinski, co-author of the study, co-founder, and CEO of DiaMonTechAG.
A total of 59 healthy persons and 41 diabetics aged 18 to over 70 took part in the study. The participants were asked to take the measurement on an empty stomach with a low blood sugar level. Over a period of two hours, a measurement was taken every five minutes. During the test phase, blood sugar levels in healthy volunteers were increased with a glucose-containing fluid. In diabetics, the usual increase in blood sugar after a meal was used instead. This ensured that measurement results were available for both low and high blood sugar levels. DiaMonTech's non-invasive measurement method provides accurate results over the entire measurement range from about 50 mg/dL to over350 mg/dL.
In the study, DiaMonTech's non-invasive method of measuring bloodglucose achieved 99.1%* accurate results. The method achieved accuratemeasurement results for both men and women - both healthy and diabetics -between 18 and over 70 years of age.
Professor Dr. Werner Mäntele, co-author of the study and co-founder of DiaMonTech AG, says: "The excellent results of our so-called "Study100" show in an impressive way the breakthrough in non-invasive blood glucose measurement. Behind this are more than 20 years of intensive research and development at the Institute of Biophysics at the Goethe University in Frankfurt and at DiaMonTech AG".
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.