Diabetes is a chronic disease which affects millions of persons worldwide. Many diabetic patients are Insulin Dependent Diabetes Mellitus (IDDM) who remain alive today thanks to insulin. Many insulin dependent diabetic patients are treated with human insulin however a significant percentage are immunogenic to this treatment and require treatment with animal insulin to remain alive. Many patients are undiagnosed leading to complications and healthcare disorders in later life.

Many patients, especially children, regularly have to undergo emergency hospitalisation to overcome hypoglycemia and hyperglycemia.

In 2000-2001 about 82,000 lower-limb amputations were performed annually in the USA among people with diabetes. Statistics show that every hour, nine people with diabetes must have a toe, foot or leg amputated to save their lives.

These are just some gruesome aspects of diabetes. Diabetes has not been cured and insulin is actually highly dangerous, so there is no shortage of motive in searching for a primal precipitating cause that might suggest more effective and safer treatment protocols.

Diabetes is the major cause of lower limb amputations, excluding trauma, and the leading cause of blindness caused by diabetic retinopathy in many countries.

The statistics of the diabetic population place a large burden on healthcare providers worldwide.

To set the clock back, on 11 January 1922 Banting and Best first injected animal insulin made from pancreatic extract into a diabetic patient in Toronto, Canada. The first injections were not successful however on 23 January 1922 a new series of injections on the boy patient resulted in a drop of the patients blood glucose levels to near normal. This medical scientific breakthrough marked the end of the sentence of death for diabetic patients who before 1922 were forced to eat sparingly as their bodies had lost the ability to metabolise food properly and at best their life expectancy was one to two years following diagnosis.

By the end of 1923 animal produced insulin was being used safely to treat diabetic patients in the Western world and purified versions of animal insulin were developed in forthcoming years.

In 1925 six year old Patricia Cheeseman was the first person to be treated successfully with insulin in the UK at Guy's Hospital, London.

understanding of DNA by Watson and Crick in the 1950's led to the development of genetic engineering techniques which led to the biosynthesis of what is now called genetically engineered or 'Human Insulin.'

The 1980's with the explosion of scientific technology clinicians became aware that many diabetic patients suffered from long term side effects of diabetes including diabetic retinopathy, neuropathy, nephropathy and other side effect disorders including hypoglycemia and hyperglycemia. It became noticeable that diabetic patients are more likely to suffer heart disease and stroke. It is now recognised that good glucose control within normal ranges can prevent many of these side and long term complications of diabetes.

Urine testing using visual urine test strips became widely available in the 1970's to diabetic patients and enabled a broad and general patient management of diabetic patients. Clinicians then recognised in the 1980's that blood glucose monitoring of diabetic patients could lead to a reduction in short and long term side effects and improve control.

In the last 20 years many self-monitoring blood glucose sensors have been developed and marketed which require a drop of blood to perform a blood test. Blood is drawn invasively by pricking the patient's finger with a needle. The blood sample is then placed on a specially treated paper strip and the colour change that takes place is correlated by visual observation, or by placing the strip in a glucose meter for analysis. The meter displays a readout of the blood glucose level expressed in mmol/l or mg/dL.

Today many meters are convenient and easy to use but can be prone to error caused by the patient's testing technique. Unusually high results (greater than 16.7 mmol/l, 300 mg/dL) or low results (less than 2.8 mmol/l, 50 mg/dL) may indicate hyperglycaemia and ketoacidosis (high) or hypoglycaemia (low) and require immediate remedial treatment action by the patient and carer with possible third party support and hospitalisation to stabilise the condition.

In order to prevent long term complications it is important to test blood glucose levels regularly throughout the day and many diabetics, especially children, hate having to perform this task due to the pain and inconvenience. Obtaining a blood sample (with a lancet or automatic figure puncture device) is the greatest barrier to measuring blood glucose and is more feared by the diabetic patient than injecting insulin. It is however essential to prevent long term complications and patient compliance is important.

Today diabetes therapy is geared towards controlling high blood glucose levels (hyperglycemia), preventing low blood glucose levels (hypoglycemia), and preventing diabetes complications. Type 1 IDDM treatment consists of a daily routine of insulin injections combined with diet and exercise therapy. Type 2 NIDDM treatment may include insulin injections or oral agents to lower blood glucose, as well as diet therapy and a weight reduction programme for overweight patients.

The monitoring of blood glucose in both Type 1 IDDM and Type 2 NIDDM is seen by physicians as being paramount to the care of both forms of diabetes. Tight glucose control leads to the risk of increase in hypoglycemia. Individual patients encounter low glucose levels and hypoglycemia at different glucose levels however a combination of sensible insulin intake, diet and exercise not only reduces the risk of hypoglycemia but also enhances the quality of life for diabetic patients, not only for themselves but also for their families and carers.

It is now generally accepted that animal insulin (porcine and beef insulin) yield physiological warning signs of hypoglycemia such as tremor, sweating and hunger, and in most patients will be experienced with blood glucose levels of 2 - 4 mmol/l. When treated with human or synthetic genetically engineered insulin an IDDM patient is likely to perceive the warning signs of hypoglycemia with blood glucose levels of 1.5 - 2.5 mmol/l and these warning signs are likely to be neurological such as confusion, sensory disturbance, behaviour change and seizure.

If not corrected hypoglycemia can lead to diabetic coma, hospitalisation and even death.