09.11.2022
News

GlucoModicum publishes first-in-human data assessing the safety and effectiveness of its MHD technology for accurate needle-free glucose monitoring

– Human data shows high correlation between concentration of glucose in samples extracted with MHD technology against capillary blood glucose samples with MARD of 12.9%

– Subsequent improvements post-trial have resulted in MARD of <9%
– Results further validate MHD for accurate needle-free continuous glucose monitoring
– Significant progress made in product development of Talisman with Philips-Medisize, a world leader in MedTech design and development

Helsinki, Finland, 09 November 2022 – GlucoModicum, a company transforming glucose monitoring with precise, needle-free magnetohydrodynamic (MHD) technology, announces that peer-reviewed data from the first-in-human study assessing the safety and effectiveness of its proprietary MHD technology for needle-free measuring of glucose levels has been published in Scientific Reports, part of the Nature Research portfolio.

Data drawn from glucose tolerance tests on healthy volunteers obtained a strong correlation between the concentration of glucose in interstitial fluid (ISF) samples extracted with GlucoModicum’s MHD technology against capillary blood glucose (CBG) samples.

The data obtained with MHD technology demonstrate a 12.9% MARD (Mean Absolute Relative Difference), a measure of the agreement between a glucose sensor reading and a reference blood glucose reading. This value lies within the range of 10-15% typically reported by commercially available CGM devices. Furthermore, no evidence of long-lasting effects on the skin were observed.

The results further validate data published in the journal Biosensors and Bioelectronics in April this year, which demonstrated that MHD integrated with a biosensor is a highly effective method for accurate determination of glucose concentrations. Additionally, GlucoModicum published data in Scientific Reports in 2021 showing that MHD extracts ISF from the skin 13x more effectively than other needle-free approaches. Taken in combination, these datasets validate the key building blocks of GlucoModicum’s technology offering: efficient extraction of ISF, strong correlation to blood glucose levels, and the integration of MHD with a biosensor in a small device. This provides a strong evidence base supporting the development of a non-invasive glucose monitor using GlucoModicum’s MHD platform technology.

Alejandro García, Chief Technology Officer of GlucoModicum, commented: “The benefits of continuous glucose monitoring in diabetes management are well documented, but broader adoption of CGM systems is limited by their cost and invasiveness. These results, the first from research conducted in humans, highlight the efficacy of our proprietary MHD technology in extracting interstitial fluid through the skin, along with demonstrating the accuracy of our approach. Recent improvements in our technology have enabled us to obtain MARD values of <9%, demonstrating an accuracy beyond many commercial, invasive CGMs.”

GlucoModicum is pleased to provide an update on the product development of the Talisman, the Company’s proprietary non-invasive CGM which uses MHD technology. In close collaboration with Philips-Medisize, GlucoModicum’s design and development partner, the Talisman continues to be developed to ensure usability and manufacturability of the final prototype.

The publication is available online on Scientific Reports here: https://www.nature.com/articles/s41598-022-21424-9

Image: Prototype of the Talisman, a non-invasive continuous glucose monitor