In 2004, the World Health Organisation (WHO) and International Diabetes Federation (IDF) projected that the number of people living with diabetes in 2030 would more than double in the following 25 years to reach a total of 366 million1. This figure, taken from the joint publication Diabetes Action Now, cited an ageing population and increasing urbanisation as primary causes for the increase.
“If commitments are merely words on paper, diabetes will continue to cause 4.8 million deaths a year and result in avoidable disease, disability and suffering for millions more.” – Global Diabetes Scorecard, IDF 20136
Today, ten years on from this initial projection, there are approximately 382 million people currently diagnosed and living with diabetes worldwide, 16 million more than projected in 2004 for the year 2030, and we aren’t even halfway there2.
The latest estimates from the IDF’s Diabetes Atlas posit that by 2035 there will be 592 million people aged 20–79 years — one adult in ten — with the disease2.
Furthermore there are 316 million people currently at high risk of developing type 2 diabetes, which accounts for 85–95% of all diabetes, and this number is expected to increase to 500 million within a generation. Given these figures, and the massive underestimation in previous predictions, we could be faced with a total of 1 billion people of all ages living with diabetes in the year 2030.
Cost, and the need for action
Described as a ‘profound concern’ in the 2011 United Nations (UN) Political Declaration on Non-communicable Diseases (NCDs), diabetes is among the leading causes of preventable morbidity and related disability across the globe3. In 2013, 5.1 million people died as a result of the disease, and many more suffered associated complications such as blindness, renal failure and amputation. Significant action is therefore required to address the inconceivable yet preventable level of suffering due to diabetes projected for 2030 and beyond.
The human cost of the disease, to individuals and their families, is staggering enough but so is the impact on health economics. Type 2 diabetes is the most expensive disease in the United States, costing $245 billion in 20124. In the UK, current spending on direct patient care is an estimated £9.8 billion (£1 billion for type 1 diabetes and £8.8 billion for type 2 diabetes), or about 10% of the overall NHS budget5. Globally, diabetes accounts for $548 billion, which is 11% of total health spending on adults.
So how do we tackle this global problem?
Clearly, any solutions must cross industry sectors, with pharmaceutical companies and healthcare systems worldwide playing a significant role, but policy, education and public campaigns to disseminate vital information are equally important.
In September 2011 at the UN Summit on NCDs, governments across the globe pledged to improve diabetes prevention, treatment and management. As an output to the summit, the IDF developed a Global Diabetes Scorecard to track the progress for action across a number of areas and in anticipation of the scorecard’s publication later this year, we explore some of the latest developments with a particular focus on education, prevention and treatments.
Education and policy
The link between type 2 diabetes and lifestyle — particularly exercise and diet — is unequivocal, and leads directly to opportunities for prevention, with education on diabetes and its complications having a significant role to play, and from an early age. For example, in August 2014 a joint initiative between the IDF, the Juvenile Diabetes Association of Brazil (ADJ) and Sanofi Diabetes launched the KiDS (Kids and Diabetes in Schools) project which will run in 15 public and private schools across Sao Paulo and Ceara, and will explain the basics of diabetes and stress the importance of physical activity and diet7. The KiDS project is also being piloted in Delhi, India, and will be made available to download in eight different languages.
In the UK, the online ‘Diabetes Risk Test’, developed by Diabetes UK, enables users to assess their risk of developing type 2 diabetes and identify appropriate next actions8. Increasing the accessibility and ease with which society can engage with such tools and information helps ‘join up’ different aspects of the healthcare system, and hence tackle the issue of early diagnosis and prevention.
Diabetes education, however, also needs to address prevention, as while advances in treatments continue, halting the projected rise in sufferers is of paramount importance.
Preventing type 2 diabetes has to begin with lifestyle changes — a reduction in physical inactivity and an increase in healthy eating. This is supported by the UN’s 2011 declaration on NCDs which called for a ‘national systems response’ ranging from the accessibility of technologies and medicines to policies against the provision and marketing of saturated fatty foods9.
‘A national systems response’9
- ‘Availability and affordability of quality, safe and efficacious essential non-communicable disease medicines, including generics, and basic technologies in both public and private facilities.
- ‘Policies to reduce the impact on children of marketing of foods and non-alcoholic beverages high in saturated fats, trans-fatty acids, free sugars, or salt.’.
- ‘Adoption of national policies that limit saturated fatty acids and virtually eliminate partially hydrogenated vegetable oils in the food supply, as appropriate, within the national context and national programmes’.
- The WHO cites physical inactivity as the fourth leading risk factor for global mortality, the cause of 6% of all deaths and the chief factor in 27% of all cases of diabetes10.
- This link between type 2 diabetes and a sedentary lifestyle might imply that the disease is most common in well-developed, high-income economies but as Figure 1 shows, this is far from the case.
Insulin based treatments
Once prevention has failed, constant treatment is required, with the injection of insulin now used by the majority of sufferers to control their type 1 diabetes. And treatments have come a long way.
Perhaps the most exciting technical advances in recent years relate to the development of potentially the ultimate treatment solution — the Artificial Pancreas (AP). While this sounds like a new body organ, it is actually a sequence of interlinking external technologies, such as sensors and pumps. ‘On the horizon’ for some years, significant progress is now being made and at the 2014 ATTD Conference, a number of studies of AP systems were reported — with ambulatory rather than solely clinical trials — with many positive results. All the key device elements are available, such as pumps and sensors, plus mobile technologies that allow use of application software, cloud connectivity, data sharing and analysis. Not all technical elements are equally mature, nor approved to the same level, so further consolidation is required, including development of control algorithms, error detection and fault management. The usability of these devices also requires serious ongoing consideration, such as the need for regular calibration or whether such devices should be used continuously or only overnight, when the majority of severe hypoglycaemic events are known to occur.
Many AP developments have resulted from collaborations, often across industry and academia, but this has proved a slow route to market; large organisations such as Medtronic and Roche now have the resources, expertise and core technologies required to make the next step. The biggest hurdle, however, may be regulatory, and the need for agreement on device classification (including supporting technologies and peripherals) and risk profiles; the development of standards and requirements (e.g. for continuous glucose monitoring); and extensive clinical trials to prove that AP systems are safe and do not lead to unintended harm due to malfunction or otherwise. All of which will take time and commitment, and funding.
There has been some interest, primarily in Europe, in implantable pumps, but the focus is primarily on wearable pumps, and AP systems can form a part of this broader trend. The first approved and commercially available AP could still, however, be years away.
In the meantime, well-established individual device technologies for sensing, monitoring and drug delivery continue to be developed, refined and combined with ever increasing functionality. Continuous glucose monitoring (CGM) systems, an alternative to the traditional finger prick / test strip approach, are available and can improve self-management and prediction / prevention of hyper or hypoglycaemia via trending data that can forewarn a patient using an alarm. Dexcom’s Gen 5 CGM is one such system and also an example of separate technologies and organisations combining as it will soon be able to link — via a Bluetooth-based mobile app — to the OmniPod pump and Personal Diabetes Manager System from Insulet.
An alternative, new non-invasive sensing technology, which may reach the market by 2030, is incorporated into a contact lens. Developed by Google and licensed in July 2014 by Novartis, the system is exciting, but will need to be accurate; not all current blood glucose monitors meet the increased accuracy levels mandated in the updated version of ISO 15197. The cost of these new technologies, and hence their availability to patients, will also be an issue.
In the pen injector market, new devices such as AllSTAR®, JuniorSTAR®, HumaPen® MemoirTM and NovoPen® 5 demonstrate how technology continues to develop to meet the expanding needs of diabetes therapy. These devices offer new features such as 0.5 IU discrete doses for paediatric use, 80 IU dose capacity in disposable pens, on board electronic aids for improved compliance, increased accuracy, reduced operating forces, and lower cost versions for developing markets. As we move towards 2030 we can expect continued performance improvements and enhancements.
In addition, new alternative technologies are emerging. Needles continue to improve, providing reduced pain on injection, which can also lead to improved compliance and acceptance of insulin therapy by people with type 2 diabetes. Studies on intradermal injections of insulin through micro-needles also show promising results, albeit at very early stages.
Harvested from animal pancreases, today’s insulins are complex, recombinant formulations and ongoing developments and refinements continue. Ultra-long and ultra-fast acting formulations, such as Tresiba® and FIAsp from Novo Nordisk, help patients cope more easily with daily requirements for background basal dosing and deliver an effective, fast response to rapid fluctuations resulting from food intake or physical activity. But, as for all drug products, the development process is lengthy and the drug needs to demonstrate safety as well as efficacy. Although approved in Europe and Japan, the US launch of Tresiba® was delayed in 2013 because of FDA concerns regarding cardiovascular safety. The next couple of years will see the patents for some current insulin formations, such as Lantus® and NovoLog®, expiring. Although the biologic nature of the drug means that generic versions are unlikely to flood the market, this milestone could increase choice and reduce costs.
A major development in 2014 was the return of inhaled insulin. Recent FDA approval for MannKind’s dry powder formulation Afrezza® was followed by a licensing agreement with Sanofi for development and commercialisation, potentially as early as 2015. Meanwhile companies such as Oramed and Merrion continue to develop oral dosage forms of insulin. These are much further away from commercialisation, but by 2030 we can expect to see a range of well-established alternatives to self-injection.
However, given the enormity of the challenge faced, what impact can these technological developments have on the overall picture?
From an engineer’s perspective, battling to limit the impact of diabetes — on individuals and healthcare systems alike — feels as much a challenge as trying to stem the relentless increase in entropy. Treatment of diabetes is a constant battle against uncontrolled glycated haemoglobin, HbA1c, and current technology advances can at best only help maintain the status quo, preventing or slowing further deterioration. The disease is multi-faceted and can behave differently every day making it incredibly difficult for even the most diligent of patients to control. Significant improvements are precious but few and far between, and although new and improved technologies have the potential to improve quality of life and control the debilitating effects of diabetes, they cannot stop or reverse them. The best opportunities for this may lie elsewhere, with alternative treatments rather than new technologies.
First developed in the 1950s, bariatric surgery (such as bypassing the small intestine) is effective as an obesity treatment. Studies now show, however, that it can also control — and prevent — the onset of, type 2 diabetes. A number of alternative surgical techniques have also been developed, with studies (including one published in the Journal of American medicine 201311) showing that these can provide significant positive outcomes, sometimes including full remission. Yet currently only 1% of those who could benefit from this therapy can access it, primarily due to health economics but also the view that interventional surgery poses more risks than benefits. These concerns are now being challenged; for example, a BMI of 35–40 is currently the limit below which bariatric surgery is not prescribed, but it is anticipated that benefits including prevention of diabetes onset, can be delivered for patients with lower BMIs.
Researchers looking into potential new treatments for type 1 diabetes are now considering chemical entities such as GLP analogues and anti-C3 monoclonal antibodies, stem cells and genetic engineering. Although at times seemingly bordering on science fiction, it is advances in these areas that may provide the opportunity to finally turn the tide against diabetes.
Fifteen years is a long time even in the pharmaceutical industry, so 2030 still seems too close for us to make accurate predictions about diabetes control. What is absolutely clear, however, is that in the meantime we must use all the tools at our disposal to improve prevention and treatment globally, and hopefully challenge current estimates for the future.
1. Diabetes Action Now: An initiative of the World Health Organisation and the International Diabetes Federation, WHO 2004 | http://te-am.co/1teAaIe
2. IDF Diabetes Atlas, Sixth Edition, International Diabetes Federation 2013
3. Draft Political Declaration of the High-level Meeting on the prevention and control of non-communicable diseases, 7 September 2011 | http://te-am.co/1otGyLR
4. Advanced Technologies and Treatments for Diabetes (ATTD) Yearbook 2013, Fifth edition, p 169
5. ‘NHS Spending on diabetes ‘to reach 16.9 billion by 2035’, 25 April 2012, Diabetes UK | http://te-am.co/1wkbuOm
6. IDF Global Diabetes Scorecard, 2014 | http://www.idf.org/sites/default/files/Scorecard-3%202.pdf
7. Kids and Diabetes in Schools (KiDS) Project, International Diabetes Federation 2013 | http://te-am.co/1nyYeVl
8. Diabetes Risk Score, Diabetes UK 2013 | http://te-am.co/1vMHA6j
9. Draft comprehensive global monitoring framework and targets for the prevention and control of noncommunicable diseases, Sixty-Sixth World Health Assembly, WHO 2013 | http://te-am.co/1zktcpC
10. Physical activity, Fact sheet No385, WHO 2014. http://te-am.co/1wkc0fj
11. Ikramuddin S. et al, Roux-en-Y Gastric Bypass vs Intensive Medical Management for the Control of Type 2 Diabetes, Hypertension, and Hyperlipidemia. Journal of American Medicine 309(21), 2240–2249 (2013).
Chris is Director of Engineering at Team and as well as leading the continued development of our engineering capability, he is also heavily involved in a wide range of projects.
Thomas is a human factors engineer at Team. He is integral to the planning and conducting of formative and summative human factors studies all over the world. Thomas has a PhD in home use medical device design.