Slowing Down the Progression of Type 2 Diabetes ... - Diabetes Care

Slowing Down the Progression of Type 2 Diabetes: We Need Fair, Innovative, and Disruptive Action on Environmental and Policy Levels!

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Peter E.H. Schwarz1,2 and Henna Riemenschneider1,3

Diabetes Care 2016;39(Suppl. 2):S121–S126 | DOI: 10.2337/dcS15-3001

Over the past decades, we have observed an increase of prevalence of diabetes in many countries along with significant differences in prevalence trends between countries worldwide (1). In Europe and other Western countries, the prevalence rate reaches a plateau or has slowed down on the level of ;8–10%. In Asia, a continuous rise in prevalence has been monitored, similar to that in Africa, and an explosion of diabetes prevalence can be observed in the Arabic region. Surprisingly, in each of the countries, there is a significant number of people who do not develop diabetes during their lives despite living unhealthy lifestyles in similar environmentsdin Europe, an estimated 10% of the population (2). These people might be the secret answer to successful individual diabetes prevention, but we still do not understand the detailed mechanisms of why some people develop diabetesdand why others do not. What we can do is observe individual lifestyle and environment as determinants for the development or prevention of diabetes and the respective risk factors including genetic susceptibility. The interplay between these determinants, influencing the probability of the individual staying healthy or how a person learns or chooses a healthy lifestyle, will define success in diabetes prevention (3). Innovative actions are needed to slow down the progression of type 2 diabetes. The purpose of this article is to offer innovative policy and environmental strategic activities designed to enable sustainable diabetes prevention with scalability on national level. Why Do We Need Environmental and Policy Changes in Diabetes Prevention?

Diabetes prevention is a success story, but it generates new challenges. Throughout the past 15 years, a number of randomized controlled trials have sought to test various interventions to prevent diabetes (4). The results are overwhelmingly positive on an individual level, with a significant relative diabetes risk reduction attributed to lifestyle and pharmacological intervention (5). There are various indicators that lifestyle change leads to more sustainable and pleiotropic effects in preventing diabetes, whereas pharmacological interventions mimic an early glucose-lowering treatment and cease after the intervention has stopped. The results from the clinical trials tell a convincing scientific success story for diabetes prevention, but the logical proof of concept is the translation to community and national programs, including scalability of interventions within the population to prevent diabetes (6). Within the past years, a number of translational initiatives have been undertaken, varying in target population, scope of intervention, communication, and dissemination of activities. These trials were not as effective in reaching an individual outcome as the clinical trials, but they have initiated an effect on overall health (4,7). Common for the translational trial was a mild change in behavior in the target population leading to reduction of some risk factor or risk behavior (7). We can assume that there was a population-based effect but that this effect was not directly attributed to diabetes alone and more commonly associated with overall reduction of unhealthy lifestyle. The understanding and evaluation are still in the early stages, and we need more experience and more information to understand the complete

1 Department for Prevention and Care of Diabetes, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany 2 German Center for Diabetes Research, Paul Langerhans Institute Dresden, Dresden, Germany 3 Department of General Practice, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany

Corresponding author: Peter E.H. Schwarz, peter. [email protected]. Both authors contributed equally to this article. This publication is based on the presentations at the 5th World Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension (CODHy). The Congress and the publication of this supplement were made possible in part by unrestricted educational grants from AstraZeneca. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

PREVENTION AND PROGRESSION OF DIABETES

Diabetes Care Volume 39, Supplement 2, August 2016

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Policy Level Type 2 Diabetes Preventive Action

network of influencing factors including environmental, communicative, behavioral, cultural, and adherence aspects (8–10). Clinical trials are good sources to learn about pathomechanisms (5). However, translational trials have shown that a clinical intervention protocol is not sufficient because it does not consider people’s individual priorities, peer support, food environment, peer priorities, and peer behavior. The consequence will be to redesign translational or population-based interventions, reconsider the message of communication and dissemination, and embed these programs into environmental and policy changes. This is a point in time when we should pause, look at what has been done, and then consider how to improve our efforts in diabetes prevention. Challenges in Prevention of Diabetes on Individual Level

The rise in prevalence of type 2 diabetes is a logical consequence of significantly changed lifestyles regarding physical activity and eating behavior throughout the past decades, observed not only in the Western countries but also around the world (11). Parallel to these developments, various lifestyle and pharmacological interventions have brought evidence on how to prevent or delay type 2 diabetes on an individual level. This constitutes the success of individual diabetes prevention based on studies and prevention goals set more than two and a half decades ago (5,12). Looking at current prevalence rates, it is evident that diabetes prevention on a population level still is a great challenge. While there have been some advances at the population level, we are not yet where we need to be, hence the need for targeting policy and the environment. On one side, we know that inherited susceptibility and inherited response to the individual lifestyle habits modulate the accumulation of risk factors on the individual level (13). On the other side, environmental factors, peer influence, and social determinants influence health behavior and can also substantially increase the risk for diabetes. Prevention of type 2 diabetes and many other chronic diseases is challenged by a socalled toxic food environment: we live surrounded by cheap, energy-rich food provided in large portion sizes, available


24/7 (14). People of all ages are targeted by marketing campaigns using emotional evidence to foster selection of unhealthy foods with false health promises. Sedentary lifestyle is dramatically increasing, and smart technology intuitively reduces our mobility and necessary daily physical activity (15). Subsequently, there is a need to update prevention strategies, which were designed 20–25 years ago (12,16,17). The individual recommendations with respect to the degree of reduction in saturated fat intake, dietary fiber consumption, and physical activity are still effective and evidenced but are not enough to compensate today’s increased energy consumption and decreased physical activity (18). Due to the environmental circumstances, the peoples’ individual challenge increases to meet the recommendations. Modern prevention strategies therefore should include strategies for helping people to meet the recommendations. However, there are campaigns to raise interest in healthy lifestyle choices, mostly being cognitive information campaigns only. These campaigns have their limits, since adherence to health behavior is influenced not only by information but also by multiple socioeconomic, emotional, and cultural factors, i.e., motivation, support, and level of education. Targeted emotional marketing campaigns adjusted to different health literacy levels (19) and promoting a toxic food environment unfortunately often provide a more attractive consumer choice. This is where environmental and policy changes could have a significant impact. Pharmacological interventions can be an opportunity to promote individual diabetes prevention and sometimes also to support lifestyle change (20). There is evidence of preventive effects of using drugs like metformin, acarbose, pioglitazone, orlistat, and sulfonylurea. With the exception of metformin, most other drugs have either limited efficacy or costly side effects (21). Interestingly, the overall results vary between 30 and 60% of relative risk reduction for lifestyle interventions and vary between 20 and 80% from pharmacological interventions (20). Regarding effects of lifestyle change, the reduction of energydense food, soft drinks, and food containing artificial sweeteners may have substantial short- and midterm effects

on diabetes risk reduction (22). The increase of daily physical activity has significant effects on lowering glucose levels and over years on a reduction of diabetes risk (23–25). With use of this evidence, walking 10,000 steps a day and cutting out soft drinks can become sufficient short- and midterm policy recommendations and public health strategies for diabetes prevention (12). Maintained healthy lifestyle prevents diabetes sustainably in the long-term. Pharmacological interventions can be an effective strategy to avoid a conversion from impaired glucose tolerance to diabetes in the short-term, being especially an option for those individuals repeatedly showing a nonresponse to lifestyle change (12). A patient-centered diabetes prevention approach, tailored to individual patients’ needs, is considered the gold standard for successful diabetes prevention management. It involves lifestyle modifications, pharmacological interventions, and self-management education and support (18,26,27). It also includes limitations, such as cost and time intensity (involving health professionals), demand on high patient adherence and professional involvement, and ability to only target/reach individuals or small groups at high risk. Information technology–based methods to improve self-management education to prevent type 2 diabetes are suggested as a large-scale solution to these problems, but at the moment there is only a limited evidence for their feasibility and effectiveness. Ongoing largescale interventions aim to overcome these challenges on a community level, and the first evaluations (7) demonstrate feasibility and effectiveness, at least in the short run. Nevertheless, it is a challenge to sustain the positive effects of lifestyle changes over the long run. The U.S. is only now beginning to be able to assess the impact of diabetes prevention efforts on a broad scale via the National Diabetes Prevention Program. Other countries are also only in early stages of national programs, which will take time to evaluate for effectiveness. Translating the methods from the controlled study settings to real-world settings and scalability to reach masses need to be supported by the environment (28). Environmental and policy changes could have a significant impact on that but may need groundbreaking new and transforming actions.

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Challenges in Diabetes Prevention on Environmental and Policy Levels

It has been proposed from all global and many national health organizations that diabetes prevention be one of the goals for public health interventions and for policy development as well as for community and state action. There is a discourse regarding how prevention of type 2 diabetes can be feasible on the community level and how policy is making a difference (9,10,29). Nevertheless, there are a number of good examples of translating the evidence into community action in the U.S. (30) and of building a state policy in the U.K. (31) and in Finland (32). Recent large-scale translational investigations on “real-world” diabetes prevention programs demonstrate modest weight loss and decreased risk for diabetes. While these results do not seem overwhelming at the individual level, from a populationlevel perspective, these could have a large impact (7,33). As community-level programs are in their infancy and still being evaluated, the first results imply that they are feasible and effective, although there still is a place for improvement. The question is how to improve what is already being done to better reach the population level. We argue that the population level in diabetes prevention can only be successful if behavioral lifestyle programs are supported by environmental and policy changes. National programs have been introduced in many countries (34), but evaluation of the effectiveness of these approaches is in its early stages and therefore the evidence of the effects on public health is limited (9,10). At the same time, prevalence of type 2 diabetes is growing, and we have no time to waste: we must connect the best available evidence (9) at political, public health, medical, and organizational levels and be innovative and think from new perspectives. For improvement of population-based prevention programs, it is necessary to look at how they are designeddor, better, at who designs them. Currently, most programs are designed by researchers who apply study undertakings into a population setting, often without involving policy makers, politicians, or business managers or entrepreneurs. Another strategic gap is the position of the person at risk within many intervention programs, still seen as a patient or individual with prediabetes but not as a “consumer.” Furthermore, healthy lifestyle

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campaigns using cognitive arguments are at a disadvantage in the battle against the marketing campaigns of food and beverage industry targeting consumers on an emotional level. If we want to reach a scalable development of diabetes prevention programs, we need to change the strategy, content, policy, and laws to reach a population impact (6,33). Together with a business-oriented management, we may be able to build an attractive product called “prevention,” which would be bought by the consumer because it addresses his or her intuitive individual needs. One of the most successful diabetes prevention activities in tackling environmental issues was a tax on saturated fatty acids in Denmark (35), but it also highlights conflicts of interest for reaching public health goals. The introduction of the tax led to a reduction of sales of products with a high level of saturated fatty acids (36) and can be extrapolated with a reduction of body weight. However, after 15 months, the tax was abolished due to aggressive lobby activities and juridical actions by the food industry (35). Recent findings suggest that industry and trade associations were heavily involved in the political process before and after implementation of the fat tax using various tactics to oppose the tax: threatening lawsuits, predicting welfare losses, casting doubt on evidence, diverting focus, and requesting postponement (35). The industry feared that the tax would lead to a reduction of sales because consumers in this market are normally very price sensitive, but this is exactly what could help to hit one of the roots of the obesity epidemicdconsumers who become more sensible with their food and beverage purchases. Policy makers must be more ambitious and maybe more disruptive in relation to food taxes, e.g., by implementing more comprehensive tax-subsidy schemes (37). A range of measures is clearly needed, since it is crucial that health, as opposed to economic interests, achieves a central role in food policy decisions (38). A Fair Leadership on Diabetes Prevention Is Needed!

Can we halt the increasing prevalence of type 2 diabetes? Yes, if we consequently address the underlying health determinants on individual and environmental

levels, and no, if we address only behaviorrelated health determinants. Prevention on the individual level can be very successful if the environmental determinants can be negated with individual activities (12). This requires substantial motivation and support and knowledge and skills to compete on a daily basis with marketing strategies for unhealthy consumer products and reduced daily physical activity (18). Nevertheless, altering the environmental conditions to reduce external influences can be very powerful in supporting individual prevention strategies, but concerted action on the policy level and by politicians who directly confront the lobby activities by the food and beverage industry is needed (15). In reality, several parts of the world suffer from a continuous and burdening increase in unhealthy and toxic food environmental conditions, parallel to only small improvements of prevention strategies (3). Diabetes prevention seems like David’s attempt to fight a continuously growing Goliath or like bailing out a sinking ship with a thimble. To slow down the progression of the diabetes epidemic, we urgently need a fair leadership in addressing all health care determinants for chronic diseases (39). Governments have an important role in this. They have the obligation to protect the population from internal and external threats, which is self-evident talking about catastrophes, infectious diseases, crimes, automobile safety, and occupational health. As the rise in obesity and the diabetes epidemic is today among the most common health threats leading to early death and increased morbidity in the population, protecting the population from these health threats should be translated into governmental actions. However, the responsibility should be shared with individuals who as consumers decide what to buy, what to eat, and how to promote their own health. For addressing both levels of prevention, a fair leadership is needed to on one side aggressively change environmental conditions to protect health of the citizens by changing policies but on the other side to encourage individuals to perform and consume a healthier lifestyle. Four Fields of Innovative and Fair Action for the Prevention of Diabetes

We argue that several innovative actions on the individual or environmental

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level are needed to slow down the progression of type 2 diabetes in a sustainable way, in addition to an individual prevention approach focusing on education and counseling. The proposed activities can be of a disruptive innovative nature, but they must be fair and accessible not only to people at risk but to everyone. Four fields of action on the policy and environmental level may enable sustainable individual diabetes prevention with scalability on the national level. 1. Liability for Adverse Health Effects of Food and Beverage Products

The food and beverage industry should be made liable for adverse health effects of their products midterm (obesity) and long term (heart attack, diabetes, and metabolic syndrome), similar to the drug industry. One example can clarify this. If 1,000 people were treated with a drug and 3 died of a heart attack, attributable to the given medication beside lifestyle factors, the drug would be withdrawn from the market due to regulatory processes. If the same 1,000 people started consuming sugared soft drinks or energy-dense food daily and 30 or even more died of a heart attack, attributable to consuming behavior beside lifestyle factors (22)dno product would be withdrawn from the market because there are no regulatory processes for this case. It could be argued that a patient cannot estimate the side effects a drug may have but understands side effects of consuming unhealthy products. But can a person really estimate the midterm (obesity) and long-term (heart attack, diabetes, and metabolic syndrome) effects of unhealthy eating behavior, in the light of emotional food and beverage marketing and considering that 59% of the population consider themselves having low health literacy, i.e., being unable or having limitations to process and understand health information (40)? Pharmaceutical companies calculate the costs of liability regarding healthaffecting side effects of their products in their business models, but this does not apply yet for the food and beverage industrydbut it could. Health liability should be rethought from a health policy perspective. Adding midterm and long-term liability for adverse health effects of food products might increase the price of the product, which would


reduce individual consumption of these products among price-sensitive consumers, and unhealthy food products would exit the market step by step as more healthy food products would enter the market. It would not necessarily change the business models of food and beverage companies and not necessarily reduce their income. Unlimited cheap sales of food products would decrease, and the industry would change to different food products to avoid healthrelated liability effects. Health policies including legislation to add a liability of adverse health effects for food and beverage products have a potential to change individual eating behavior to healthier and less energy-dense food consumption. Furthermore, they also have the potential to change long-term business strategies to the production of more qualitative healthy food products. 2. Food Labeling That Supports Individual Health Choices

A worldwide food-labeling system using color coding or a five-star system that would be known from Internet services should be introduced to highlight healthy products. The food and beverage industry should be obliged to print easy-to-read labels on prepacked foods to facilitate customers actively choosing healthy and avoiding unhealthy products. Combining food labeling with plain packaging strategies would foster the effect (41). Investigations show that food labeling can reach short-term effects in influencing purchasing behavior regarding consumers with a basic interest in a healthy lifestyle (38,42). It also reduces influences of food product marketing strategies that often are not incorrect in legal terms but false based on scientific evidence, confusing consumers, especially children and people with a low literacy level (19). It is known that the easier it is to interpret the food labeling, the more consumers can be reached (40). Interestingly, a number of attempts to develop easy-to-understand food labeling systems in the European Union were replaced with an ingredientsbased labeling of food items driven by lobby interests from the industry, which is shown often not to help consumers in making healthy choices (8). A labeling system using color coding or a five-star system should be considered as an attractive strategy to support individual healthy

food and beverage purchases and to reach people with low health literacy. 3. Health Tokens: A Currency for Health Increasing Liquidity in the Prevention Market

An increasing number of publications (43–48) analyze various kinds of incentives to encourage people to have a healthy lifestyle. In the business sector, literature addresses the development of regional or targeted currencies (bitcoin and community-based currencies) (43,49). These concepts could be combined to develop a currency for health, “health tokens,” that enables incentives to be used repeatedly (50). Health tokens could be collected or earned by consuming health care services that improve health conditions and a healthy lifestyle, such as walking 10,000 steps a day and eating fruits. Later, these tokens could be used to purchase healthy products and health and prevention services, such as buying vegetables or going to the gym, turning the incentive from a “gift” to a “currency” that has become an individual purchasing value. Introducing health tokens might generate a number of advantages for the health sectordthe largest economic body in most of countries but often suffering from the lowest levels of liquidity due to high regulation. Through establishment of a system of health tokens, the consumer collects liquidity by living healthy. This liquidity can only be used for again consuming healthy products and preventive activities that would generate a closed loop of increased liquidity within a “healthy market.” In some scenarios, the liquidity could increase by up to 30% (50)da powerful added value in a market normally suffering from not enough liquidity. The gain in liquidity and health tokens income would help people and peers to target attention to healthy lifestyle products and strengthen prevention business. The competitive advantage of health token currency would increase as more people and health partners participate. The result would be an increased consumption of health services and a gain in health capital of the individual on the population level. Health tokens, therefore, can work as a true currency for individual and environmental prevention to improve individual health and to foster the prevention market.

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4. Tax Exemption for Sustainable Business Models in Diabetes Prevention

Tax exemptions could be used to focus entrepreneurs’ attention to prevention business models to make investment in prevention an attractive business opportunity. A tax exemption for prevention services and products could speed up the development of sustainable individual prevention strategies. The potential loss of state tax income could be compensated by a tax increase for energy-dense food. The tax exemption would provide an attractive opportunity for start-up companies as well as larger health care partners in the health care sector to focus on a healthy lifestyle, prevention of chronic diseases services, and businesses. Over time, this could generate a virtuous cycle, where the increased income increases liquidity in the health care sector due to reduced taxes and may be bolstered by health tokens generating a growth in the healthy lifestyle and prevention market. An advantage of this idea is that politicians and policy makers only have to build a framework of legislation to keep the system stable but do not need to regulate the system itself. The tax exemption can pinpoint health determinants that are the most relevant in the communities on the regional or national level and may vary between regions and countries. Supporting positive individual health behavior through tax exemption instead of “punishing” of unhealthy behavior through a tax increase would send a positive signal and generate a powerful booster for healthy behavior and prevention services (51). Conclusions and Outlook

People with diabetes or prediabetes need support and self-management skills to control their disease and to promote healthy lifestyles. The education- and counseling-based strategies to support individuals need to be extended: novel groundbreaking action on the environmental level is required for the ability to control the diabetes epidemic and promote healthy lifestyles in the public. New policies including a liability for adverse health effects of food and beverage products are needed. Modern health policies must take into account the short-, mid- and long-term health effects of food and beverage products. Developing labeling strategies of food products will highlight healthy food products in a toxic food environment and help consumers

Schwarz and Riemenschneider

achieve informed decision making, especially those with lower health literacy. Developing strategies to incentivize a healthy lifestyle by health tokens may bolster and scale up the implementation of healthy lifestyle strategies by also increasing the liquidity in the “healthy” health care sector. A tax exemption for prevention services will speed up the development of sustainable individual prevention strategies. These policy components can give the framework in which business models can be developed to strategically orient on sustainable healthy lifestyle and prevention products. Allowing entrepreneurs the power and safety to invest in healthy prevention businesses can increasingly lead to sustainable individual health outcomes in the population. Researchers have answered enough questions for the individual prevention of type 2 diabetes. Individual support will continue to be the basic element of diabetes prevention, but we need to include the environmental and policy levels in the prevention strategies to reach population-level effects. In the future, evaluation of reallife approaches and of implementation of national diabetes strategies can bring more information regarding prevention on the population level. But it is also important to use the scientific evidence further in the evaluation and quality management of prevention business. We argue that improvement of diabetes prevalence on a public health level can only be achieved by a policy shift from individual to shared responsibility. Moreover, health should be seen as a value in business and society. We, as researchers, have to pass the baton to governments, entrepreneurs, policy makers, and tax lawyers. The foundation for the prevention of diabetes has been laid. Now, the baby “prevention” has reached puberty. In order to mature and to finally halt the rising prevalence of type 2 diabetes, implementation, scalability, and sustainable business must become a shared, transforming action including business and policy partners. Recommendations for the Prevention of Diabetes Recommendations for Policy Makers c

c

Develop health policies and legal framework including liability for adverse health events of food products Enable a food-labeling system that is easy to understand for people at all

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c

health literacy levels and that targets consumer attention and decision making in favor of healthy products Increase tax for unhealthy and energydense food products and reduce income tax for start-up businesses in the field of prevention of chronic diseases, based on mid- and long-term health outcome Forbid marketing of unhealthy food and beverage products targeting children up to an age of 16 years and selling unhealthy products at schools

Recommendations for Entrepreneurs c

c

Develop business ideas and plans for diabetes prevention targeting a sustainable health outcome for the consumer Develop and implement health tokens as currency for health: the consumer can receive health tokens for buying healthy products and in turn trade them in for other health-related goods

Recommendations for Consumers/Persons at Risk c c

Avoid toxic food environment with daily consumption of energy-dense food Implement the evidence-based prevention on a daily basis: walk 10,000 steps a day, cut out sweetened and artificially sweetened soda drinks, and eat five portions of fruit and vegetable per day (one portion equals a handful)

Recommendations for Physicians c

c

c

Explain the short- and long-time effects of health behavior change to patients Use individual strategies to anchor patient motivation for an healthy active lifestyle Consider any drug that improves insulin sensitivitydpreferably metformindand assist patients with reducing body weight

Duality of Interest. No potential conflicts of interest relevant to this article were reported.

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