CGM for Diabetes
Diabetes is characterised by the body’s inability to regulate blood glucose levels. Consequently, accurately measuring blood glucose is critical to the management of this disease. The current practice for the self-monitoring of blood glucose (SMBG) requires testing freshly drawn blood, usually extracted from the fingertip with a lancet. In addition to the pain and inconvenience of the test, the readings can be dangerously inaccurate and provide limited information to the user. A major breakthrough in this area will be the widespread adoption of wearable Continuous Glucose Monitoring (CGM) devices. Such devices have the potential to develop patient tailored treatments, negate the need for finger-prick blood samples and provide crucial time-resolved blood glucose data. They can directly reduce the incidences of mortality and long-term complications of the disease and directly lead to better patient outcomes. Although there are several encouraging CGM devices already commercialised, all of these lack the consistent accuracy, stability and glucose specificity that is truly required for calibration-free, accurate CGM. CGM is also at the core of a technology that can offer a potential cure – the ‘artificial pancreas’.
Ziylo’s innovative solution for CGM based on a totally unique glucose-binding molecule that was invented and patented by us. It is engineered for the maximum possible accuracy in the very dangerous low blood glucose (hypoglycemic) range and does not suffer interferences caused by everyday substances (paracetamol, aspirin, Vitamin C and red wine) which are problematic for existing technology.
CGM for Biopharmaceutical Process Control
Biopharmaceuticals have already led to a large number of life-saving, multi-billion dollar therapies. Their production depends on cutting edge cell culture techniques that are critically reliant on precisely controlled glucose levels.
A major concern in this industry is batch spoilage due to improper growth medium support (poor glucose level control), which can be extremely costly. The contamination risk increases when samples are taken ‘off-line’ for testing (which is also time consuming). This is a key reason why the biopharmaceutical industry is moving towards smaller-scale, disposable and routinely sterilisable bag-lined reactors Our technology is perfectly suited to providing a patch-type or ‘printed’ sensor that does not compromise the sterility of the reactors and can work ‘in line’ (does not require sampling or filtering) as required by the industry.
Regulatory changes are also placing increasingly stringent demands on the consistency of the biopharmaceuticals produced. A key parameter under scrutiny is the ‘glycation profile’. This is the extent to which the biopharmaceutical surface is covered by glucose and a very precise control of glucose concentration is essential in obtaining the consistent glycation profile required to meet regulations. Incorrect glycation profiles can lead to batches being discarded at huge financial cost. The potential accuracy of our sensing platform is ideally suited to meet this need.
Current systems for CGM must continuously withdraw and filter a sample from bioreactors in an ‘on-line’ regime. Clogging of these ‘on-line’ systems is a major consumer concern. This industry requires ‘in-line’, easily sterilised sensors (using standard biological autoclave steam sterilisation) for CGM. Our sensor is ideally suited to ’in-line’ sensing technology. It is designed to reside inside the reactor, in continual contact with the medium and so does not require pumping or filtration of fluids.
 Fonseca, V. A.; et al. American Association of Clinical Endocrinologists consensus statement, Endocrine Practice, 2016, 22, 1008-1021.