Periodic Reporting for period 2 - PREVENTDIABETES (The world’s first needle-free continuous glucose monitor to prevent and manage diabetes at scale)
Okres sprawozdawczy: 2023-02-01 do 2024-01-31
Diabetes is one of the biggest health concerns globally: 6% of the world’s population already lives with diabetes, and another 35% is at a high risk of developing it. Proper management of diabetes starts with consistent and accurate monitoring of glucose levels. Yet, most diagnosed diabetics do not monitor their blood sugar as often as prescribed, because it is painful and inconvenient to do so.
We have invented, patented and productized a new technology category for extracting and analyzing blood sugar levels in a completely non-invasive way. The project’s objective objective of the project is to further miniaturize, optimize, and clinically prove this technology on a wider scale. The financing will turn our break-through scientific discovery into an end user device that can potentially impact over 2 billion people by helping them prevent diabetes onset altogether.
We have invented, patented and productized a new technology category for extracting and analyzing blood sugar levels in a completely non-invasive way. The project’s objective objective of the project is to further miniaturize, optimize, and clinically prove this technology on a wider scale. The financing will turn our break-through scientific discovery into an end user device that can potentially impact over 2 billion people by helping them prevent diabetes onset altogether.
By the end of the project, we have:
completed POC 1 and 2 with TALISMAN;
clinical performance studies with Flint and TALISMAN have shown good results and are continuing;
achieved desired results in software development for TALISMAN device;
focused on the size and weight reduction of the device;
confirmed the sensor performance to deliver the needed analytical performance.
Overall, we have reached the desired outcomes of the PREVENTDIABETES project.
completed POC 1 and 2 with TALISMAN;
clinical performance studies with Flint and TALISMAN have shown good results and are continuing;
achieved desired results in software development for TALISMAN device;
focused on the size and weight reduction of the device;
confirmed the sensor performance to deliver the needed analytical performance.
Overall, we have reached the desired outcomes of the PREVENTDIABETES project.
A market winning glucose monitoring system (medical device) needs to be accurate, small size, affordable and easy to use. These requirements are fundamentally important, yet at the same time very difficult to achieve. It takes a lot of time and iterations to address these topics. During this project GM has taken clear steps to address these elements in a very credible way. At the same time the scientific foundation of the technology has been peer-reviewed by the global scientific community.
To our understanding, not many companies have been able to make this type of progress. Hence, this could be considered as high impact and GM has been able to push forward the state of art concerning produtization of a new platform technology.
Clinical performance and validation:
We conducted 10 glucose tolerance tests on 5 healthy volunteers and obtained a significant correlation between the concentration of glucose in ISF samples extracted with MHD and capillary blood glucose samples. Upon calibration and time lag removal, the data indicate a Mean Absolute Relative Difference (MARD) of 12.9% and Precision Absolute Relative Difference of 13.1%. In view of these results, we published results that discuss the potential value and limitations of MHD in needle-free glucose monitoring beyond the state of the art (https://doi.org/10.1038/s41598-022-21424-9).
Integration of the key technology components.
We demonstrated that an integrated magnetohydrodynamic fluid extractor and an amperometric glucose biosensor can be used to develop a wearable device for non-invasive glucose monitoring. We optimized the enzyme immobilization and the interface layer between the sensing device and the skin. The monitoring device was evaluated by extracting fluid through porcine skin followed by glucose detection at the biosensor. The results are published (https://doi.org/10.1016/j.bios.2022.114123).
To our understanding, not many companies have been able to make this type of progress. Hence, this could be considered as high impact and GM has been able to push forward the state of art concerning produtization of a new platform technology.
Clinical performance and validation:
We conducted 10 glucose tolerance tests on 5 healthy volunteers and obtained a significant correlation between the concentration of glucose in ISF samples extracted with MHD and capillary blood glucose samples. Upon calibration and time lag removal, the data indicate a Mean Absolute Relative Difference (MARD) of 12.9% and Precision Absolute Relative Difference of 13.1%. In view of these results, we published results that discuss the potential value and limitations of MHD in needle-free glucose monitoring beyond the state of the art (https://doi.org/10.1038/s41598-022-21424-9).
Integration of the key technology components.
We demonstrated that an integrated magnetohydrodynamic fluid extractor and an amperometric glucose biosensor can be used to develop a wearable device for non-invasive glucose monitoring. We optimized the enzyme immobilization and the interface layer between the sensing device and the skin. The monitoring device was evaluated by extracting fluid through porcine skin followed by glucose detection at the biosensor. The results are published (https://doi.org/10.1016/j.bios.2022.114123).