Next generation in-blood glucose monitoring using non-invasive optoacoustic sensing

Project Information

GLUMON

Grant agreement ID: 101058111

DOI

10.3030/101058111

Project closed

EC signature date 21 March 2022

Start date 1 May 2022

End date 30 April 2026

Funded under

• The European Innovation Council (EIC)

Total cost

€ 2 344 210,50

EU contribution

€ 2 194 210,00

Coordinated by

HELMHOLTZ ZENTRUM MUENCHEN DEUTSCHES FORSCHUNGSZENTRUM FUER GESUNDHEIT UND UMWELT GMBH
Germany

Periodic Reporting for period 2 - GLUMON (Next generation in-blood glucose monitoring using non-invasive optoacoustic sensing)

Reporting period: 2023-05-01 to 2024-10-31

Summary of the context and overall objectives of the project

Diseases falling within the metabolic syndrome are increasing in prevalence throughout the global population. Diabetes is a growing problem that affected 50 million people in the US, UK, and EU alone in 2021. This number is projected to grow to 54 million by 2025. Worldwide, it affects almost half a billion people. Type-2 diabetes represents more than 90% of all cases and is predicted to grow at a slightly faster rate than type-1.
Measurement of glucose levels in the bloodstream remains fundamental in diabetes management, yet current technology for glucose measurements in diabetic patients are either invasive and obtain blood samples through a finger prick, or use non-invasive glucose monitoring devices, which nevertheless require frequent calibration based on finger prick measurements.
GLUMON aims to leverage progress in optoacoustic detection, developed under the FET project RSENSE (GA #862811), to offer the next generation of quantitative non-invasive biochemical sensing in-vivo, with technology that addresses the limitations of existing biomedical sensors. A driving innovation is the ability to offer accurate glucose measurements in a portable way that would offer superior performance to transdermal sensors in a completely non-invasive fashion, i.e. without the need for penetrating the skin barrier.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

1) HMGU team has demonstrated position and depth-selective glucose sensing in mice in vivo by combining visible optoacoustic microscopy with mid-IR optoacoustic microscopy/spectroscopy for direct glucose-in-blood sensing (open-access publication available).
2) First preliminary sensor design
3) Validation studies with phantoms, mice, and a pilot study with humans (ongoing)
4) Clinical partners (TUM-MED and MUG), together with HMGU team, have acquired various feedback regarding ethics and MDR
5) Based on preliminary results from the pilot study, TUM and MUG are working on their study protocols for submission to ethics committee
6) Updated business plan and business model, as well as preliminary FTO analysis carried out

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The glucose monitoring market includes all the different devices and drugs used across the patient journey. To deliver appropriate insulin dosing, glucose monitoring is crucial. While new solutions such as non-invasive glucose monitoring are emerging, blood glucose monitoring (BGM) and continuous glucose monitoring (CGM) still dominate the market. CGMs emerged as a response to this demand, providing continuous, or near continuous glucose measurements in non-blood samples. However, this often translates into inaccuracies given the time lag between glucose concentrations in blood and the intersticial fluid, requiring calibration with a BGM. Despite being painless, using a CGM requires wearing a disposable sensor attached to the patient's skin, which is deemed a source of inconvenience by some prescribers and patients. Additionally, these devices are significantly more expensive than traditional options.

GLUMON is a glucose-monitoring device currently under development that performs non-invasive measurements of glucose with improved accuracy and reproducibility. In addition, it avoids any skin damage thanks to its novel optothermal technology, based on layer selection. Moreover, no consumables are needed to operate, reducing the high environmental and economic impact of conventional solutions while simplifying the measurement process.

Key needs for further uptake and success:
a) demonstration and validation studies
b) miniaturization
c) further market research
d) additional investment
e) IP management
f) regulatory and compliance framework