Most of the non-invasive methods under development are continuous glucose monitoring methods and offer the advantage of providing additional information to the subject between the conventional finger stick, blood glucose measurements and over time periods where no finger stick measurements are available (i.e. while the subject is sleeping).
Investigations on the use of test strips have shown that the required self-injury acts as a psychological barrier restraining the patients from sufficient glucose control. As a result, secondary diseases are caused by excessive glucose levels. A significant improvement of diabetes therapy might be achieved with an implantable sensor that would continuously monitor blood sugar levels within the body and transmit the measured data outside. The burden of regular blood testing would be taken from the patient, who would instead follow the course of their glucose levels on an intelligent device like a laptop or a smart phone.
Glucose concentrations do not necessarily have to be measured in blood vessels, but may also be determined in the interstitial fluid, where the same levels prevail – with a time lag of a few minutes – due to its connection with the capillary system. However, the enzymatic glucose detection scheme used in single-use test strips is not directly suitable for implants. One main problem is caused by the varying supply of oxygen, by which glucose is converted to glucono lactone and H2O2 by glucose oxidase. Since the implantation of a sensor into the body is accompanied by growth of encapsulation tissue, the diffusion of oxygen to the reaction zone is continuously diminished. This decreasing oxygen availability causes the sensor reading to drift, requiring frequent re-calibration using finger-sticks and test strips.
One approach to achieving long-term glucose sensing is to measure and compensate for the changing local oxygen concentration. Other approaches replace the troublesome glucose oxidase reaction with a reversible sensing reaction, known as an affinity assay. This scheme was originally put forward by Schultz & Sims in 1978.A number of different affinity assays have been investigated,with fluorescent assays proving most common.MEMS technology has recently allowed for smaller and more convenient alternatives to fluorescent detection, via measurement of viscosity.Investigation of affinity-based sensors has shown that encapsulation by body tissue does not cause a drift of the sensor signal, but only a time lag of the signal compared to the direct measurement in blood