Diabetes, its treatment, incidence and impact on global health systems is, it seems, continually in the public eye, writes John Pritchard.
The cost of diabetes to healthcare systems continues to grow – it’s currently estimated at $245bn in the US alone – with the obesity epidemic driving type 2 diabetic incidence rates. So what can technology do to address the situation?
The Diabetes Control and Complications Trial study (1993) in the US and the UK Prospective Trial (1999) demonstrated that better control of blood glucose levels leads to reduced incidence of diabetes complications. Measuring blood glucose levels frequently is one element of that better control. The test strip systems used to carry out that testing have been developed over the years since those studies – to use smaller volumes of blood, provide results in shorter periods of time, and give the ability to test from alternative sites (eg arm, thigh) – with the aim of reducing the impact of testing on patients in terms of pain or ease of testing. Other ease-of-testing developments have been integrated systems (lancets and test strip together).
However, patients have been demanding more accurate testing which has driven manufacturers to improve their strips or manufacturing process to meet the new requirements of the FDA and ISO 15197 standards. Coupled with reduced reimbursement rates, the test strip market has seen lower growth and, as a result, a number of the major players are rumoured to be up for sale.
Despite that, new products from strip suppliers have focused on providing tools to help patients manage their disease. Software programmes that provide enhanced feedback, insulin bolus calculations and better graphical means of patients visualising their results have all been developed and launched. Demonstrating improved patient compliance by better (lower/reduced) HbA1c values is how strip suppliers are looking to provide value to healthcare systems.
This approach is reliant on the developments in connectivity that we have seen over the last 10 years. This digital health ‘movement’ is looking to provide the means for a diabetic and their doctor to manage their disease better, integrating not only testing but also treatment. Automatically recording insulin injections, blood glucose results, carbohydrate intake and exercise, distilling that to an individualised treatment regime based around insulin dose suggestions, with all that data available via the ‘cloud’, is close to being available. Demonstrating that this approach does indeed manage patients’ disease better and so reduces the cost of diabetes to healthcare systems will be key to its adoption. The fact that a lot of these approaches rely on the use of smartphones will require acceptance by the regulatory bodies – and the Foods and Drugs Administration has laid out guidelines on the use of ‘apps’ as medical devices.
The last two years have seen major advances in the development of ‘closed loop’ or artificial pancreas systems. Long the dream of researchers, this does appear closer than ever. Improved performance of continuous glucose monitors (CGMs), insulin pumps with Bluetooth capability, and the development and refinement of the algorithms that adjust the insulin delivery have been shown to control patients’ diabetes more tightly with a lower incidence of hypoglycemic episodes. When the first such system will be sent for regulatory approval is as yet not clear, but the response from type 1 diabetics who have trialled such devices has been enthusiastic.
The challenge once that hurdle is overcome will be how will these systems be reimbursed? What will the uptake be outside the US? While insulin pump therapy has been shown to be beneficial in disease control, its uptake in the UK, for example, is very low (less than 5% compared with over 40% in the US) – the cost to the national Health Service being the issue rather than patient acceptance. How will healthcare systems approach these ‘closed loop’ systems? Type 1 diabetes charity JDRF estimates that an artificial pancreas could save $1.9bn over 25 years in the US.
While the advances above will help type 1 diabetics manage their disease better, as well as those type 2 patients being treated with insulin, what can technology do for the type 2 patients? Estimates in the US suggest the average lifetime cost of treating a type 2 diabetic is $85,000. That would suggest that preventative action or approaches to delay complications will reduce the impact on healthcare systems.
Studies of reduced-calorie diets – such as those from Newcastle in the UK – have shown that the dependence on drugs to treat diabetes can be reduced by substantial weight loss. The UK’s National Institute for Health and Care Excellence (NICE) has just changed its guidelines as to which patients would be appropriate for bariatric surgery – to include those diagnosed with diabetes. The number of patients who would qualify for this approach would cost the NHS millions. How will that be paid for?
What other options are there that would cost less than surgery? Could a combination of CGM technology, activity monitors and cloud-based coaching teach patients at risk of, or with, type 2 diabetes better lifestyles that will delay the disease complications – and would that be a better use of resources than surgery? This is an area where we are seeing developments from many different companies all over the world with a ‘crossover’ of consumer products that were originally targeted at sports people into medical devices. Those of us working in the field and patients look forward to technology providing further advances to manage the disease and ultimately reduce the burden on healthcare systems.
John Pritchard is Head of Diagnostics at Cambridge Consultants