Continuous analyte monitoring to aid clinical practice

• Considerable progress has been made in the development of practical glucose sensors for in vivo use. In some designs, the sensor can be replaced by the patient, who "injects" a new sensor into a fresh site using a hypodermic needle. An open-loop hypoglycaemia sensor providing an alarm signal could be available soon, and it would be very useful in the management of diabetes. The sensor for this application would need to function for a minimum period of about 12 hours. Further developments in the glucose sensor area are expected to lead to a comfortable implantable sensor/pump device, which would provide closed loop control for a prolonged period. An acceptable system would be a sensor replaced every 2 to 3 days, coupled with a microprocessor-controlled pump replaced after 2 to 3 years. Further engineering input is needed to design the monitoring and control unit containing the alarm and pump systems. The world market in clinical analysis is about US $6 billion, and covers about 10% of the total expenses for health care. It is in the field of continuous microsensors that future competition for the clinical diagnostic market will take place. Funding in vivo projects is less attractive to industry than the more proven and well-established area of in vitro diagnostics. However, the benefits of in vivo monitoring to the health of the community, and the financial rewards to manufacturers are ultimately great. It is clearly of interest for industry to invest in the development and commercialisation of this high added-value technology.

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