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GlucoBeam: A portable device for pain-free glucose self-monitoring in diabetic patients

Periodic Reporting for period 2 - GlucoBeam (GlucoBeam: A portable device for pain-free glucose self-monitoring in diabetic patients)

Periodo di rendicontazione: 2018-03-01 al 2020-11-30

Diabetes mellitus (DM) is one of the largest health challenges currently faced by modern society, affecting over 400 million people in the world. DM cannot be cured, but via well-controlled therapy, a high quality of life with diabetes can be obtained, with a minimum of short- and long-term complications. The key to a successful diabetes therapy is a well-controlled blood glucose level, which is obtained by carefully balancing insulin intake, diet, and exercise and with Self-Monitoring of Blood Glucose (SMBG) as a cornerstone. Conventional SMBG is an invasive test requiring the patient to prick his/her finger with a lancet to extract a blood droplet onto a disposable strip for electrochemical analysis of the glucose concentration. Repeating this uncomfortable and painful task 4-8 times per day leads to severe loss in life quality, often resulting in poor compliance leading to costly complications.

RSP’s proprietary non-invasive SMBG technology relies on the capabilities of Raman spectroscopy for directly detecting individual substances, refined by a unique critical depth optical scanning to collect glucose signals from the right tissue depth range, thus avoiding sources of errors during the measurement. Our device will enable DM patients to test their glucose levels in around 30 seconds and as often as desired – at no added cost or pain – thereby empowering them to better manage their treatment and minimizing the risk for acute complications.
The overall objective of the project is to undertake all required miniaturization activities to transform RSP System’s current tabletop prototype for non-invasive glucose monitoring into a lunchbox-sized system and demonstrate its performance in a large clinical trial to thoroughly document its performance. In addition, the project focus on preparing for commercial exploitation, which will enable RSP systems to penetrate the multi-billion diabetes glucose monitoring market.
The project started on 1 March 2017 and was supposed to continue until the end of August 2019. However, in this second reporting period, we have faced two suspensions periods which have extended the duration of the project which now will run until late 2021. During this reporting period covering 10 months of the project period the work carried out has concentrated on the safety of the lasers, miniaturization and productization activities as well as optimization of algorithms and calibration models. We are now progressing towards a market-ready device and its clinical validation. In this regard, we have worked on identifying suitable clinical partners for the new bigger pilot study

Main results include:
- Development of cost optimized product specifications and design plans for miniaturization
- Mobile app architecture lay-out and user-interface design with beta version ready for demo activities
- Optimized data analysis algorithms and improved calibration model
- Established strategic partnering with 3 leading hospitals for pilot trials in Denmark and Germany
- Implementation of quality management system and preparing for ISO 13485-certification
The project has the potential to impact health care systems by increasing patience compliance, thus lowering the costs of complications and reducing the loss of societal earnings. The direct impact counts both physical and physiological factors, for the patient and his/her surroundings. It goes from bettering the patients finger condition, to helping him/her achieving better metabolic control and increased compliance, to helping families take care of their children and elders through pain free measurements.
Our strategy to bring an adjunctive device to the market allows both to shorten time-to-market and to rapidly monetize our disruptive technology, empowering RSP to cover its medium term innovation strategy. In sum, our non-invasive device is targeted at a billion global market and its commercialization will represent an aggregate turnover of approx. €253 million over the 5 years post-project. It has the potential to reach double digit billion savings for EU healthcare system and will lead to significantly improved life quality for diabetes patients.
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