The number of global diabetes sufferers is expected to grow from 151m in 2000 to 221m by 2010 to 300m by 2025. In Western Europe, North America and Japan, there were 32m people with type 2 diabetes in 2000 and this is predicted to grow to 41m in 2010 and up to half of these will remain undiagnosed for several years. The latter are conservative estimates and several sources suggest the true figures may be at least 25% higher, with some suggesting that as many as 20% of adults may have diabetes today.
The chart opposite shows the global incidence of type 2 diabetes. Details of the global threat of diabetes can be found at www.idf.org/home/index.cfm?node=204
Diabetes is a costly disease, which often accounts for over 10% of national healthcare expenditure in the developed world. In the US , total cost of diabetes is estimated at between $100bn and $140bn. The cost to the NHS of diabetes care in the UK was $7.5bn in 2000 and this could reach $15bn by 2010. Diabetes could grow to consume 30% of Western healthcare budgets.
In 2000, the global market for diabetes drugs was $8.1bn and this could grow to $20bn by 2006 and $30bn by 2010, with most of the growth coming from oral antidiabetic drugs for the management of type 2 diabetes.
The chart opposite shows the growing market for oral antidiabetic drugs, which is fueled largely by type 2 diabetes.
Type 2 accounts for 90% of all diabetes cases and it is estimated that currently only half of those who have the disease have been diagnosed. Diabetes UK estimates that the average time from onset to diagnosis of type 2 is currently 9 to 12 years, and up to 50% of newly diagnosed patients already show signs of severe complications of the disease on diagnosis.
Late diagnosis of type 2 diabetes carries a major health risk; untreated diabetes often leads to blindness, kidney disease, amputation and other serious conditions. To delay or avoid the onset of diabetes complications and the related additional costs, it is essential that diagnosis is made as early as possible and that glucose levels are reduced to safe levels in diabetic patients.
The American Diabetes Association recommends that people over 50 years are screened every year for diabetes, while Diabetes UK recommends screening every 3 years for those at risk of the disease. The American College of Endocrinology recommends screening adults periodically from age 30 years. The UK government has placed early detection of type 2 diabetes at the heart of its strategy for diabetes care.
Monitoring of glucose in diabetes
Daily monitoring of Type 1 diabetes
Although some 90% of diabetes is type 2, diagnostic monitoring in diabetes has focused almost exclusively on type 1, in which daily use of blood glucose strips and meters is required for self-management of insulin therapy. Glucose meters are uniquely suited to monitoring of insulin injecting diabetes, as the patient requires quantitative test results several times each day.
Infrequent monitoring of type 2 diabetes
Most type 2 diabetics do not use insulin and therefore require only infrequent testing. These patients are not usually provided with glucose strips and meters, as they are expensive and not suited for infrequent testing. SSt is developing glucose biosensor products screening and infrequent monitoring in type 2 diabetes.
Glucose testing in type 2 diabetes
Laboratory, clinic and in-pharmacy tests are limited in application to testing in type 2 diabetes. Glycated haemoglobin (HbA1c) tests, which are used for long term monitoring, are not suitable for screening, as they show poor sensitivity.
Low cost urine dipstick tests have been widely piloted as a screening test for diabetes and are also used as an alternative to glucose meters for type 2 monitoring. These products have been found to suffer from a high rate of false negative results and therefore urine dipsticks are generally not recommended for screening.
The best test for screening and infrequent monitoring of type 2 diabetes measures early morning fasting glucose, however this test suffers from poor patient compliance, due to problems of patient access and clinic logistics.
Recent clinical studies have shown that afternoon fasting glucose tests may detect only half of type 2 diabetics compared to early morning fasting tests. Random blood glucose testing, where the patient has not fasted, can be performed at any time, but can be misleading and routine use of this test would result in a large number of erroneous results.
The early morning fasting glucose test is the test most recommended for screening for type 2 diabetes.
SSt products for type 2 diabetes
The SSt glucose biosensor smartcard test
SSt's low cost, low usage approach to quantitative testing is ideally suited for screening and monitoring in type 2 diabetes, as patients can test themselves at home shortly after arising from bed in the morning. SSt's first products will incorporate a glucose biosensor and will be ideally suited for performing an early morning fasting glucose test at home.
SSt and type 2 screening
SSt will enable accurate periodic screening for type 2 diabetes.
SSt diabetes products will be quantitative and yet will be simple to use and require no instrumentation. Test results will be automatically stored in an electronic record, allowing trends in fasting glucose levels to be compared over time and test results to be transferred to a patient's electronic record held by a healthcare provider.
SSt and type 2 monitoring
SSt type 2 monitoring tests will allow periodic checking of fasting glucose levels in patients with type 2 and will be used to provide patient assistance and compliance monitoring. Patients following a diet and exercise programme will use SSt products for periodic feedback on progress linked to assistance from healthcare professionals.
Users of the SSt system will be able to choose how they conveniently collect their test information and how they obtain professional advice, using services based around email, web site access, telephone, digital TV and regular postal mail or personal contact provided by a community pharmacist or a nurse.