Periodic Reporting for period 1 - FAIRGLUCOSE (Affordable and sustainable self-powered GLUCOSE sensing system for a global FAIR diabetes management)
Reporting period: 2022-05-01 to 2023-10-31
An estimated 463 million people already live with Diabetes. It is considered as a silent epidemic that claims 4.2 million lives worldwide every year. Fortunately, if self-monitoring of blood glucose levels is provided, patients enjoy a good quality of life. While technologies for disease management have evolved significantly (e.g. continuous glucose monitoring devices (CGM), insulin pumps) diabetes screening appears to be today an important hurdle. Almost one in two adults with diabetes are unaware of their condition (240 million). Its symptoms (frequent urination, thirst, weight loss, vision changes and fatigue) appear progressively and are often neglected. As a result, the disease may be diagnosed several years after its onset, once complications - like kidney and eye damage or an increased risk for heart disease or stroke - have arisen. For these reasons, some diabetes associations recommend screening people at risk of developing T2DM at least every third year and yearly after reaching 45 years. The availability of suitable tools in the primary health care (PHC) for early identification is one of the biggest challenges in promoting health and disease prevention. Generally, diabetes screening is prescribed by practitioners when patients visit primary care for other health issues. In these cases, fasting blood sugar and/or glycosylate haemoglobin (HbA1C) is checked. Alternatively, regular screening campaigns are organized at local pharmacies or primary care centres. In these campaigns, people get a capillary blood analysis and under an abnormal glucose level, are advised to look for confirmatory laboratory testing and given some guidance about health habits. However, these campaigns have very limited turnover, always limited to the number of available testing sites, glucometers and trained staff, that have no tools to follow-up or engage individuals under high-risk.
FAIRGLUCOSE presents a low cost and single use glucose sensing system to enable massive and ubiquitous diabetes screening. The key component consists of an enzymatic fuel cell that generates electrical power that is proportional to the glucose content of a sample. The self-powered sensor signal is managed with a proprietary minimalistic circuit and can be integrated in a card with near field communication that transfers glucose result to a cell phone. The device has several features that make it a promising candidate to enable distributed glucose testing: (1) It is affordable and has a minimal environmental impact due to its reduced electronic content and lack of battery. (2) Its card format together with its battery-less conditions enables massive distribution by regular mail to people’s homes for self-testing (3) test result is read in the cell phone, that becomes and IoT node with dual use: it provides glucose result and risk score to the individual under test but also stablishes connection with a healthcare provider. This connection with the patient cell phone can be used to inform the healthcare system and to enable patient’s follow-up by encouraging him/her to take a subsequent blood test, to reach a clinic for further assessment or to follow recommendations for a healthier lifestyle.
FAIRGLUCOSE presents a low cost and single use glucose sensing system to enable massive and ubiquitous diabetes screening. The key component consists of an enzymatic fuel cell that generates electrical power that is proportional to the glucose content of a sample. The self-powered sensor signal is managed with a proprietary minimalistic circuit and can be integrated in a card with near field communication that transfers glucose result to a cell phone. The device has several features that make it a promising candidate to enable distributed glucose testing: (1) It is affordable and has a minimal environmental impact due to its reduced electronic content and lack of battery. (2) Its card format together with its battery-less conditions enables massive distribution by regular mail to people’s homes for self-testing (3) test result is read in the cell phone, that becomes and IoT node with dual use: it provides glucose result and risk score to the individual under test but also stablishes connection with a healthcare provider. This connection with the patient cell phone can be used to inform the healthcare system and to enable patient’s follow-up by encouraging him/her to take a subsequent blood test, to reach a clinic for further assessment or to follow recommendations for a healthier lifestyle.
During the SUPERCELL ERC Consolidator Grant, the potential of the approach was demonstrated by building-up a proof-of-concept prototype with NFC communication capabilities using a commercial chip solution. Method correlation with a laboratory reference method with 5µl of serum samples with a manually manufactured fuel cell was proven. After that, FAIRGLUCOSE project has focused in overcoming the engineering challenges associated to reduce the glucose fuel cell to match the footprint of commercial glucose electrodes, to reformulate the enzymatic cocktail of the anode as well as the cathode ink – that until then had been manually deposited with a spatula – so they could be integrated in a future scalable process (screen printing or micro dropping) without a loss in performance in terms of voltage and current density. At the end of the project, we have achieved the downsizing of the overall electrode size and proved method correlation of the screen-printed fuel cell with plasma samples from a local Biobank A WEEE assessment comparing traditional glucometers with the proposed GLUCOCELL solution estimates that the carbon footprint of our device is 11 times lower than the regular solution, being the elements with larger impact the LCD displays and the coin cell batteries.
The most relevant milestones achieved in the path of validating the technology are: the obtaining of an enzyme-mediator with a low oxidation voltage that is compatible with the glucose strip manufacturing processes, the in-house formulation at laboratory level of anode and cathode printable inks, the obtaining of an operative fuel cell with similar footprint to a glucose test strip, and a successful method correlation validation with 30 doped-plasma samples in the range of 70 to 360 mg/dL. Estimated BOM for the self-powered glucose measuring unit has been set to 0.25€ which is also within the price initially targeted in the project proposal.
The most relevant milestones achieved in the path of validating the technology are: the obtaining of an enzyme-mediator with a low oxidation voltage that is compatible with the glucose strip manufacturing processes, the in-house formulation at laboratory level of anode and cathode printable inks, the obtaining of an operative fuel cell with similar footprint to a glucose test strip, and a successful method correlation validation with 30 doped-plasma samples in the range of 70 to 360 mg/dL. Estimated BOM for the self-powered glucose measuring unit has been set to 0.25€ which is also within the price initially targeted in the project proposal.
FAIRGLUCOSE project has achieved its planned goals.In order to evolve the technology towards the market the next technological steps will entail showing the feasibility and usability of a self-powered sensor card technology for glucose self-testing. These goals will require the consecution of objectives that are technical, regulatory and business-oriented. The technical objectives are (1) Proof device feasibility in card format by integrating the self-powered technology within a NFC card and running a clinical pilot with 500 patients that yield sensitivity and specificity values over 95% versus commercial fingerpick glucometer. (2) Demonstrate device usability as self-test. This objective is focused on proving usability in simulated operational environment with selected volunteers following ISO 15197 with a user acceptance over 90%. The future business-oriented objectives are (1) Seek for synergies with a glucose strip industrial partner (2) Understand how screening is performed in the different HI and LMIC regions and identify device specific requirements to address every application in terms of design features (single or multiple measurements, app incorporating risk surveys or symptoms) and minimum accepted price and quantify the addressable market for the two applications of the glucose sensing card in those territories to reach at least a TAM of least 10M units/year. When the previous tasks are ready, we will deliver a business plan ready for investors.