Untitled Document

Technology Overview

The Need for an Implantable Glucose Sensor

Approximately 5% of the population are diabetic. This is a chronic condition without a means of permanent cure. Depending upon its severity, it is controlled by daily insulin injections, drugs or, in mild cases, diet. Early-onset (Type 1) diabetics, in particular, suffer a substantial reduction in average life expectancy. (Diabetes is the fourth leading cause of death). This is due to long-term deleterious physiological effects, especially on the circulatory system, and to sudden death due to loss of glucose control during sleep. Many clinical studies have indicated that the more blood glucose concentrations are carefully controlled within normal limits, the less likely is the patient to suffer serious secondary consequences of the disease. In order to achieve such control, it is necessary to monitor blood glucose concentrations frequently in order to determine appropriate insulin doses and dietary responses.

Currently, the only well-proven, reliable means to determine blood glucose levels is by acquiring a small blood sample by pricking the finger and making a measurement with one of a range of commercially available sensing devices. There is an existing market for instruments and test strips of approaching $3billion per annum worldwide. Yet even in the USA where there is relatively good medical education, only 56% of diabetic patients monitor blood glucose at all (source, Gallup survey sponsored by Lifescan Inc, 1998). In addition, the average testing frequency is 1.2 times per day compared to American Diabetes Association recommendations of 3-4 times per day for Type 1 and 1-2 times per day for Type 2 (non-insulin-dependent). One significant reason for this is the negative effects of long-term, frequent finger pricking for the patient. In addition, even such regular monitoring does not protect the least well controlled patients (brittle diabetics) from the possibility of passing into coma and possibly dying during sleep.

The Cybersensors solution is radically different and arises from a combination of technologies from widely different fields. Each technology is well proven and documented within its existing field of application. Thus the development of the Cybersensors glucose product is a true, relatively predictable development program, not a speculative R & D project. The product concept is a small (about 1cc volume), malleable flexible biocompatible sensor for insertion subdermally through a small incision. There are no permanent connections, communication being by wireless means i.e. radio. There are no unstable components and the detection mechanism is physical.A use life of at least two years is envisaged and it can be recalibrated remotely.

A variety of devices have been developed that can supply insulin to the body, some of which are implantable. If a reliable glucose monitor was available, this could be used to control such devices via a feedback loop, enabling an 'artificial pancreas'. Such a sensor would also offer the possibility of an alarm to prevent the possibility of drifting into coma during sleep. However, in spite of much effort over a period of about 20 years, no such reliable device has been forthcoming. The best that has been achieved is a few days of carefully controlled use using a hard-wired, invasive sensor. The reason for this is that these biosensors are based on relatively unstable enzyme components when used within the body and inherent biocompatibility problems for such structures.

It is based upon the amalgamation of three technologies: battery-less RF microchips, polymeric systems developed for drug delivery and micro-sensors of rheological changes. A recognized leader in diagnostics and joint inventor of one of the leading glucose diagnostic products and an internationally recognized expert in microelectronics and radio communications have conceived the product concept

The product offers a relatively low cost, patient- friendly method to test glucose levels at any time and a unique capability of safeguarding against the dangers of diabetic coma.