Views of Leading Stakeholders

A Vision for Digitally Enabled

Diabetes Care in Europe

Views of Leading Stakeholders

August September 2020

John J. Nolan Adjunct Professor, Department of Clinical Medicine, Trinity College Dublin

Tanja Valentin Director External Affairs, MedTech Europe

Introduction

Across Europe, the demand for healthcare is exceeding the available capacity and resources. This is driven by an increasing burden of chronic diseases, associated with an ageing population, changing habits and new environmental realities. The current models of healthcare provision are likely unsustainable to meet these increasing demands.

There are about 60 million people with diabetes in the European Region1 , the majority having type 2 diabetes-, and the numbers are rising rapidly. People with diabetes face a higher risk of serious health complications including cardiovascular events, blindness, amputations, and kidney failure. Pandemic dDiabetes comes withpresents manifold challengesmanifoldmany challenges and needsrequires the healthcare systems to adapt and remodel to address these growing threats to personal, social, and economic wellbeing.

Prevention ofReducing the risk of developing diabetes is the logical first priority. However, while type 2 diabetes can be prevented or delayed in clinical trial settings, where a highly controlled environment and treatment regime is established, there has been no large-scale success at prevention at a population level. Relying on individual lifestyle changes alone has not been successful. Whole societies and governments need to drive the necessary changes. Moreover, type 1 diabetes is an autoimmune disease and cannot be prevented at all. Enabling people living with diabetes or those at high risk of developing diabetes to manage their condition with integrated digital solutions will support long-term change.

A digital transformation of diabetes care has the potential to empower systems to manage costs and engage their resources efficiently; to improve the quality and continuity of care for people with diabetes, including by reducing geographical barriers to access to care; to enable better governance and policy planning in areas beyond diabetes; and finally, to foster innovation and collaboration among industry players to develop products and solutions to support diabetes care.

This paper captures the insights and ambitions of patient advocacy groups, healthcare professionals, policymakers, and industry representatives focused on a better, and achievable, future for people with diabetes.

1) https://www.euro.who.int/en/health-topics/noncommunicable-diseases/diabetes/data-and-statistics

Commented [c1]: Reference to type 1 diabetes?

Commented [c2R1]: I would remove mentioning type 2 here instead: “There are about 60 million people with diabetes in the European and the numbers are rising rapidly”.

Commented [TV3R1]: ok

Commented [JN4]: I would omit this sentence. Research is very active on different fronts in the prevention of type 1 diabetes. Although no effective prevention has been found so far, there are many new approaches and major efforts in this area.

2

Methodology

To formulate a concrete vision for diabetes care in 2030, we interviewed a spectrum of leading professionals in the diabetes field, people with diabetes, as well as leaders of the major medical diabetes technology companies.

These interviews were conducted during April and May 2020, andMay 2020 and coincided with the international health crisis of the Covid-19 pandemic, which continues to be the top political and public health priority across the globe.

Interviewees and contributors:

Tadej Battelino, Consultant and Head of Department of Paediatric and Adolescent Endocrinology, UMC Ljubljana, Head, Chair of Paediatrics, and Professor of Paediatrics at Faculty of Medicine, University of Ljubljana. Co-organiser of the ATTD meetings on diabetes technology

Katarina Braune, Medical doctor in paediatric endocrinology at the Charité Hospital Berlin and co-lead of the EU Horizon 2020 OPEN project. Living with type 1 diabetes

William Cefalu, Director of the Division of Diabetes, Endocrinology, and Metabolic Diseases, NIDDK, Bethesda,

Maryland, USA

Robert Gabbay, Chief Scientific and Medical Officer, American Diabetes Association, Alexandria, Virginia, USA

Bastian Hauck, Director, International Diabetes Federation Europe. Diabetes advocate, patient entrepreneur,CEO & founder Founder, of #dedoc° Diabetes Online Community.dedoc.de. Living with type 1 diabetes

. Lutz Heinemann, Leading expert on diabetes technology. Co-founder and former CEO of Profil Germany. Former

mManaging editor of the Journal of Diabetes Science and Technology

David Kerr, Diabetologist, director of research and innovation at the Sansum Institute, Santa Barbara, California.

Author of the textbook ‘Diabetes Digital Health’ (Elsevier, 2020)

Dirk Mueller-Wieland, Diabetologist, former President of the German Diabetes Association (DDG). Aachen, Germany

Niti Pall, Europe Regional Chair of the International Diabetes Federation. General practitioner based in the West

Midlands, UK

Louis Philipson, Diabetologist, ex-President of the American Diabetes Association. Based at the University of

Chicago, USA

Christel Schaldemose, Member of the European Parliament from Denmark. Chair of the European Parliament

Working Group on Diabetes

Hood Thabit, Diabetologist, Manchester University NHS. Expert on insulin pumps, CGM and closed loop diabetes technology

Formatted: Font: Not Bold

3

From the Diabetes Sector Group of MedTech Europe:

Erik Bjorkman, Senior Vice President, General Manager EMEA, Dexcom

Anders Dyhr Toft, Vice President of Commercial innovation, Novo Nordisk

Federico Gavioli, Vice President Diabetes EMEA, Medtronic

Dagmar Kownatka, Head Healthcare Transformation & VBHCHead of Professional Relations, Roche Diabetes Care

Stuart Morton, Vice President EMEA, Lifescan

Ansgar Resch, Divisional Vice President Diabetes Care EMEA, Abbott Diabetes Care

Slobodan Radumilo, Vice President and General Manager, Diabetes Care EMEA, Becton DickinsonVice President / Gen. Manager Medical Diabetes Care Europe & EMEA, Becton Dickinson

Robert Schumm, President and Head of BGM Business, Ascensia Diabetes Care Robert Swanborough, General Manager Europe, Insulet

Abbreviations:

AI aartificial

intelligence T1D Type 1

Diabetes T2D Type 2

Diabetes

Formatted: Font: (Default) Calibri, Bold, Font color:

Custom Color(RGB(84,43,157)), English (United States)

Formatted: Indent: Left: 0", First line: 0.45"

Formatted: Font: Not Bold, Font color: Auto

Formatted: Font: (Default) Calibri, Font color: Auto,

English (United States)

Formatted: Font: Not Bold, Font color: Auto,

Condensed by 0.1 pt

Commented [TV5]: Capital ‘A’ needed: but it messes up the formatting…

Commented [c6R5]: Noted. For Davide / final design version

4

The Impact of Covid-19

The Covid-19 pandemic has had seismic impacts on all aspects of life across the globe. Among these, Covid-19 has led to unprecedented strains on health systems. The crisis-driven focus on prevention of Covid-19 infection has taken the attention of health systems away from all other health concerns, particularly long-term chronic medical conditions. Waiting lists have increased and individual face-to-face consultations have had to either be cancelled or minimized and replaced by remote contacts.

It has become clear that people with diabetes and other chronic health conditions such as high blood pressure and the metabolic syndrome have much worse health outcomes with a Covid-19 infection.1,2

While Covid-19 has taken the attention of the public and countries’ crisis responses, the diabetes pandemic has continued in the background, unabated. This heightened risk environment has led to serious consequences for people with diabetes beyond higher mortality rates, including a rise in mental well-being needs associated with the cognitive load of Covid-19 risks, barriers in access to care while social distancing, and delays in care. The broader impact of these consequences will become clearer in the coming months and years.

Across Europe, governments and health systems have reacted at an unprecedented speed to cope with the viral pandemic. The Covid-19 crisis has shown how rapidly everything in the healthcare system can change. If there is any good news from the crisis so far, it is that Covid-19 has promoted the adoption of telemedicine and various digital health solutions to address the needs of people with diabetes. Essentially, the Covid-19 crisis has convinced those in the diabetes field to go virtual, and virtual solutions have been seen to work.3,4,5,6 In fact, telemedicine and new digital health solutions hold the promise of becoming an essential part of a new, high quality standard of care, complementing and ensuring linkage to essential services that still need physical interaction. Covid-19 has accelerated progress toward a digital diabetes clinic, and has highlighted that this digital transformation will be led by the needs and circumstances of people with diabetes.

Diabetes care is likely to change significantly in the longer term because of the impact of the Covid-19 pandemic. While 2030 is a long time away, the viral pandemic has shown that linear thinking can be a weakness in future strategic planning for healthcare. Healthcare professionals have shown a willingness to adopt new technology if this does not add burden and helps them manage their patients. People with diabetes have also seen that continuity of care, including when provided remotely, has the potential to improve their quality of life. Systems of care have the potential to improve efficiency and spending, while providing tailored, personalized care.

However, despite some clear advantages that have been observed for people with diabetes, there is a substantial risk that payers and practitioners will revert to the pre-Covid way of working and interacting with patients. The way how are set upThe current systems for health insurance and reimbursement of care might increase this risk of reverting to pre-Covid ways.

Covid-19 has had a profound impact on so many around the world. Supporting the adoption of teleconsultations and other digital solutions is clearly a central priority for the current and possible future pandemics and will be critical for chronic disease management.

Telemedicine opportunities have been widely adopted and shown to be helpful so far during this crisis. More expansive and holistic digital solutions are also achievable. Provided there will be the appropriate investment and leadership by policymakers, fully integrated digital diabetes care can be the norm by 2030, promising to improve outcomes and quality of life for people with diabetes.

1 https://www.idf.org/aboutdiabetes/what-is-diabetes/covid-19-and-diabetes/1-covid-19-and-diabetes.html 2 https://www.thelancet.com/action/showPdf?pii=S2213-8587%2820%2930238-2 3 https://bjd-abcd.com/index.php/bjd/article/view/585/737 4 https://www.lefigaro.fr/flash-actu/coronavirus-explosion-des-teleconsultations-en-mars-en-france-20200331 5 https://www.liebertpub.com/doi/10.1089/DIA.2020.0161 6 https://journals.sagepub.com/doi/full/10.1177/1932296820932958

Commented [c7]: Anja: Reference

Commented [c8R7]: We could reference: https://www.idf.org/aboutdiabetes/what-is-diabetes/covid-19-and-diabetes/1-covid-19-and-diabetes.html https://www.thelancet.com/action/showPdf?pii=S2213-8587%2820%2930238-2

Commented [TV9R7]: I would take preferably European sources. One from patients, one from professionals (cannot open the links)

Commented [c10R7]: See in footnotes. John, if you have other preferred sources, please let us know!

Commented [c11]: Anja: References

Commented [c12R11]: See additions in footnotes. The last two are more American-oriented, but really speak to our messages and are from leaders in the field and present at the ATTD digital forum meetings

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt, English (United States)

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt, English (United States)

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt, English (United States)

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt, English (United States)

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: Font: 8 pt

Formatted: English (United States)

5

Diabetes 2030: A Snapshot

Before their in-depth qualitative interviews, participants were asked a series of ranking questions about the future of diabetes care. Here is a high-level snapshot of these results.

Figure 1: Average of all respondents’ scored results, from 1 (complete negative) to 10 (strongest positive), on key

questions about the future of diabetes care

Chapter 1. The Digital Threshold: Common Themes on

Diabetes Care in 2030

Consistent themes and conclusions emerged from our conversations with experts in the field, from healthcare professionals to policymakers, patient representatives to health system specialists and device manufacturers. We examined common threads first, followed by a focused perspective for the different stakeholder groups.

The Future of Diabetes Care - The Effect of The Covid-19 Pandemic on Digitiszation of Care All respondents stated in one way or another that diabetes care will change permanently because of the impact of the Covid-19 pandemic. The crisis has accelerated the evolution of health systems to deploy digital health solutions and telemedicinevirtual care. Many saw this as constituting a permanent change.

Some commented that governments would pay more attention to diabetes, having seen the extent to which it was a significant additional risk factor for those with Covid-19.

The Covid-19 crisis has convinced people to go virtual – and it works!

The crisis has also strengthened the case for greater investments in staff, technology, and treatment to drive improvements in diabetes care, particularly after many years of under-funding. Clearly, however, the Covid-19 crisis will also bring significant budget pressure, at least in the short term.

Covid-19 has accelerated progress towards a fully digital clinic.

More Personalised Care Another recurring theme is that diabetes care will become more personalised and precise as a result of our growing understanding of the genetic and underlying physiological bases of different forms of diabetes. We now know that type 2 diabetes is not just one disease, but rather a complex array of many sub-types.

Commented [c13]: Anja: suggest removing “the future of diabetes care”

Commented [c14R13]: I think it’s fine to keep

Commented [TV15R13]: Agree to delete, it’s about themes, not yet summarizing that this will be the future

Commented [c16]: Anja: Not sure this quote should be

the one - how do we measure that it works or is just a

question of needs reference??

Commented [c17R16]: I think it’s a powerful quote. And the references above from specialists also substantiate it.

Commented [TV18R16]: Would tend to agree: to check with John!

Commented [JN19R16]: This is a direct quote (and several of my interviewees stated it similarly). I would prefer to keep it

Commented [c20]: Brigitte: please delete “now”…..we have known this T2 complexity for quite some time, it is not something of today

Commented [TV21R20]: Agree

6

This has important implications for medical undergraduate and postgraduate education, due to the need to foster a better appreciation of complexity. This will be matched by better diagnostics and personalised treatment strategies including through coaching.

A New Clinic Setup: Rethinking Diabetes Care Experts agree that by 2030, routine clinical practice will have been transformed, with a move towards telemedicine, at the time of the patients’ choosing and often in their home. People with diabetes spend on average X minutes per quarter with their health practitioner, whilst they need to make Y times per day personal ‘clinical’ decisions related to their condition without decision support. This set up The current system, where 0.03% of total time is spent with a specialist (and the rest of the time the patient is left to fend for themselves), has not workedis far from optimal. Health systems need to rethink the diabetes care paradigm in the face of rapidly increased diabetes prevalence, increased obesity, and serious long-term negative outcomes.

This is the death of the routine clinic appointment.

Most routine care (80% of episodes) could be handled fully via telemedicine. Much of this could be via artificial intelligence (AI) and smart algorithms, or even with an Avatar as clinician. This is virtual diabetes care. In contrast to today, there will be much better support between telemedicine visits and more individual care in response to acute episodes (i.e. the other 20% of episodesconsultations, including situations such as new diagnosis, change in therapy, emergency episodes, intercurrent illness )illness).

Functioning electronic health records are crucial to a virtual clinic and digitally enabled care in general. They pool available data in one place and allow it to be translated into valuable information that can drive better decision making and thus improve individual and societal outcomes. Policymakers have been preoccupied by privacy concerns, but these concerns are now outweighed by the inflating costs of diabetes care and the potential benefits for people with diabetes. Experts believe that people with diabetes would be willing to share their data with diabetes teams given a sense of mutual respect and trust. People with diabetes will be much better informed and empowered, following the provision of better education.

The Risks of Social Inequality and Lack of Access While interviewees were generally optimistic, concern was expressed by some that socio-economic factors, including poverty as well as, lack of education and other inequalities could limit the success of the newdigital and health literacy is a serious barrier for virtual diabetes care. Many people do not and will not have the resources or capabilities to interact digitally. The lack of digital education (among the public) remains a major barrier. A joined-up healthcare system with an electronic health record is a crucial prerequisite to realise the vision of a virtual diabetes care model.

Technologies That Will Drive the Digital Transformation of Care There has been a giant leap in digitiszsation because of the Covid-19 crisis, accelerating the use of telemedicine and strengthening the foundations for more integrated artificial intelligence (AI) in diabetes. The experts’ view is

Commented [c22]: Anja suggests removing

Commented [c23R22]: I think it’s fine

Commented [TV24R22]: It’s fine to delete

Commented [c25]: Anja: Reference?

Commented [TV26R25]: Usually IDF refers to that diabetes people see their HCPs once/15min per quarter. I think it is calculated from that. Carlo: can you find this number sumwhere.

Commented [JN27R25]: I prefer the original text. It is no longer the case that people with diabetes attend clinic every 3 months. Let’s agree a final wording.

Commented [c28]: Anja: Can ‘this’ be clarified? Seems

a bit strange this way (if you only read this quote)

Commented [c29R28]: I wouldn’t remove this. It’s a powerful quote, draws the reader’s attention, especially with the following block of text.

Commented [TV30R28]: Would agree to keep it. To Check with John if further words were used to explain what was said. What is meant by ‘this’?

Commented [JN31R28]: This is a direct quote and I strongly recommend to keep it. ‘This’ refers to what has happened since the Covid 19 pandemic.

Commented [JN32]: I prefer to keep this quote, even though Bastian Hauck has suggested another. This was a real quote from one of those I interviewed, and is more powerful I think

Commented [c33]: Anja: This and the following heading are too similar

Commented [c34R33]: I think they are fine. I see the first as macro-level influencers of change (AI, telemedicine connectivity, data ownership). The second is about concrete technologies and their deployment in the future (CGM interoperability and closed loop).

7

that this digital transformation will be driven mostly by the needs and experience of the people with diabetes. A simple analogy here is the smartphone, which was designed with the user journey in mind and is now widely available, easy to use and fully interoperable.

8

The use of AI will increase, as will precision care, not so much from genetics but from much better physiological and behavioural phenotyping. This will lead to the identification of sub-groups, greater use of individual parameters and better customised coaching. Clinical care will be mainly telemedicine, often by an Avatar as clinician who could handle most routine care with face-to-face clinics consultations available on demand.

People with diabetes could own, access , or even commercialize and share theirtheir data more seamlessly across and allow data to be used by the various systems and geographies. Patient-led projects regarding data generated data (such as of dedoc.org and diabetes.co.uk) will have much greater power and influence on future drug and technological developments. Data will should be integrated from different sources (e.g. continuous glucose monitoring, EKGs, Fitbitwearable devices) and will be further enabled by AI to tailor care to the individual, allowing for specialist review in cases of higher diabetes distress. People with diabetes will have greater responsibility for self-care, but they will also be greatly empowered by new technology.

’Smart’ Technologies Continuous Glucose Monitoring will be used in T2D management and for those at risk of developing T2D, allowing for much earlier interventions. Hypertension management systems will have a renaissance, especially in light of the Covid-19 experience. There will be much better home blood pressure monitoring technology. Non-traditional outcomes such assuch as sleep (a surrogate of wellness) will receive much more attention. Food monitoring and control (which is still very weak) will improve, with more accurate recording of both food composition with a focus on carbohyrdatescarbohydrates and caloric content, as well as the food that is actually consumed.

Sensor technology will be universally used. Closed loop systems currently represent a remarkably diverse array of systems with multiple software platforms. Thoese are likely to become, but these will be interoperable in the future. An AI advisor system could become a commonly used option towill support whatever treatment is being used, helping to interpret data and confirm dose titration.

Data Platforms and Supply Chains New platforms will be developed to support the assimilation and integration of data (continuous glucose monitoring, other devices, etc). Remote testing, including drive-by services, will be available as needed, with electronic health records key to progress.

Some people still struggle with technology, even with a phone call, or downloading home glucose data. Lack of education is a serious barrier for virtual care.

Automated interventions will be needed to cover staffing shortages, particularly in primary care, which will struggle to cope. There will be a need for regional digital centres to monitor compliance and adherencewhether a treatment or therapy fits the individual person’s needs. Diabetes education and support will be available online and across time-zones. Supply chains will also adapt, for example with more new drone delivery systems forof medicines and medical devicesdrugs and medical products, meaning patients could have rapid access to their treatment supplies.

Formatted: Not Expanded by / Condensed by

Formatted: Not Expanded by / Condensed by

Formatted: Not Expanded by / Condensed by

Formatted: Not Expanded by / Condensed by

Formatted: Not Expanded by / Condensed by

Formatted: Not Expanded by / Condensed by

Formatted: Not Expanded by / Condensed by

Commented [c35]: Anja: this is already the case today

Formatted: Default Paragraph Font, Character scale:

105%

Commented [c36R35]: Perhaps add: “People with diabetes could own, access, or even commercialize, their data more seamlessly across systems and geographies”

Commented [TV37R35]: Like the suggestion

Formatted: Not Expanded by / Condensed by

Formatted: Not Expanded by / Condensed by

Formatted: Not Expanded by / Condensed by

Commented [c38]: Brigitte: “patient-generated data”----- should this not be “patient advocacy”, if you mention dedoc (which is dedoc.org) and diabetes.co.uk? These organisations do not generate data, but are patient advocacy in my mind…

Formatted: Default Paragraph Font, Character scale:

105%

Commented [TV39R38]: Agree with the comment, but don’t like the word advocacy

Commented [c40]: From Anja: This is quite a strong

statement on interoperability. Does this represent the

view of all interviewees? Perhaps this should be

explained as it is a complex question

Commented [c41R40]: No red flags were raised on interoperability from Business Leadership. I also checked the notes and BLs broadly agree on interoperability in the future.

Commented [TV42R40]: See my tweaks to soften the ‘absolutility’of the sentence

Commented [c43]: From Anja: two different topics

Commented [c44R43]: I think this works

9

Figure 2: Illustration of data integration at a national level in Scotland

Source: Dr Brian Kennon, National Clinical Lead for Diabetes, Queen Elizabeth Hospital, Glasgow

Diabetic

Inpatient

Linkage

Systems

Community

Health Index

Scottish Diabetes

Systems

Reporting

Laboratory

Results

Commented [c45]: From Simona: This is an example of

a registry - many country have this and it does not

seem clear what the connection with 2030 is, i.e. what

will be different? Do we envision the same across

Europe?

Commented [c46R45]: We could edit the explainer: “data integration as seen in Scotland could be a standard for registries across Europe, and in turn promote better decision-making and advance diabetes care outcomes across Europe”.

Commented [TV47R45]: I like the explainer (it can leave out the words ‘for registries’) – to check with John!

Commented [JN48R45]: This is not just a registry (as seen in some other countries). It shows a national linkage of multiple data systems and registries, and right through to primary care. Agree that the edited explainer (Carlo’s) is an improvement.

10

The Challenges Arising from Digitiszising Diabetes Care Despite these exciting technological trends, numerous challenges have been highlighted that might obstruct or limit the uptake of digital innovation into daily practice.

Data Privacy, Security and Trust

Legal protection of data security and data privacy are concerns shared by most interviewees. The misuse of healthcare data is seen as a real risk. Healthcare data needs to be handled under the strictest compliance with the EU General Data Protection Regulation, and consistently integrate existing and upcoming EU ethical principles related to AI AI when further developing digital diabetes care. This will help to maintain and improve societal trust in digitisszation of diabetes care and to strike a better balance than other jurisdictions such as the United States. Digital health literacy and transparent communication will also be critical to foster trust in the security of data and systems of care.

Costs

Costs remain a major challenge for diabetes care. Investing now to save on preventable complications in the longer term remains an issue, as governments usually work on 3 to 4-year timelines and with highly siloed budgets. An increased use of technology ultimately comes with an investment, and this might not reduce direct healthcare expenditure for diabetes care and digitaliszsation in the short-term. However, if solutions are simple, pragmaticeffective, and achievable for most diabetes population segments (an analogy is smartphone applications), they can be a key element to manage the condition and prevent progression or postpone a deterioration of the disease statusprogression. This will ultimately help to avoid or reduce long-term healthcare and societal costs.

Inequality

The ‘digital divide’ could become an example of social and educational inequality. Many people will continue to lack access, health literacy, and education to engage with the digital transformation of care. Current clinical practitioners may also lack the skills to identify whether people have actually understand and have gained the necessary knowledge to self-care. More positively, regional and wider geographical distribution of care will become more equal as experts will be able to access isolated and marginalised social groups more easily.

Changes in Medical Practice

Medical practice itself is confronted with the many changes entailed in the digital transformation. The role of the specialist will change greatly, from that of an in-person clinician to more of a manager of larger clinical cohorts from a distance. The increase in telemedicine will necessarily impact the doctor-patient relationship, with reduced eye contact and the possibility of touch. One example cited is that of a paediatrician, whose care benefits greatly from seeing a child in person to assess his or her overall wellbeing and progress (e.g. clothing, care, developmental status, interaction with parents and others).

Commented [TV49]: I understand UK English is with a ‘z’ = please check for whole document to be consistent

Commented [c50]: From Anja: Is this a justified

statement? I.e. do we have something to back this up?

Commented [TV51R50]: I think it means the comment on the US? John, any thoughts?

Commented [JN52R50]: Good point. I think best to omit the phrase referring to the US (not sure where that came from either).

Commented [c53]: Brigitte: ” prevent or

postpone…..progression » -------this is very skew: change to “ prevent progression or postpone a deterioration of the disease state”

Commented [c54R53]: Suggest adding “prevent progression”

Commented [TV55R53]: Agree, see change

Commented [c56]: From Simona: Solutions to bring

savings in the long term have to be effective, simplicity

does not necessarily means improvement in care

Commented [c57R56]: Suggest swapping “pragmatic” with “effective”

Commented [TV58R56]: Sounds good to me

11

Chapter 2. Stakeholder Perspectives on the future of

Diabetes Care

The Perspective of theThe Person with Diabetes

Respondents set out a positive picture overall for people with diabetes, with improvements in care driven by better technology and medicines, as well as a more holistic approach.

Decreased Burden

Experts see a significant lessening in the daily burden of living with diabetes, with a resulting improvement in quality of life. Quality of life and wellness include important desired non-traditional and not directly medical outcomes, such as improved sleep and time in range (the proportion of time when the blood glucose level is within safe and pre-defined limits, i.e. not too high or too low). Several interviewees (people with diabetes as well as clinicians) stressed the importance of these quality of life parameters in living with diabetes. Greater autonomy for the people with diabetes and having access as needed to specialist input would help. While these benefits are likely to apply to many with T1D, this might not be the case for older people, especially with T2D. Interaction with complex IT systems and loss of one-to-one contact with clinicians could be a problem for these individuals. Giving more responsibility to the people with diabetes for self-care might in fact increase their burden while still reducing their dependency on the physician.

Empowered Patient as Customer

Several interviewees described a future diabetes care service that is much more customer-focused and egalitarian. The service will be based on need and able ability to respond to need. People with diabetes will have much more say in when and how to be seen. They will have more power and will play a much greater role in informing policy and guidelines. These policies and guidelines will be much more on the terms of people with diabetes. Coaching and support in clinical care will be provided by ‘people like me’ as opposed to the traditional clinical setting.

Sleep quality is a surrogate of wellness for people living with diabetes.

People with diabetes will become decision-makers, enabled by remote technologies and greater freedom of choice.

The Clinical Visit

Different views emerged on how the clinical visit will evolve. Respondents generally agreed that the traditional routine diabetes clinic (often 3-monthly) visit will disappear. In the future, it is likely that visit formats will vary according the personal preference of the person with diabetes. Some will prefer to have problem-oriented visits on an as-need basis. Some will want open-ended access to discuss anything, including non-diabetes issues. Nevertheless, there will be a move to shared decision-making and shared ownership, which will require training, and which can be digitiszsed and leveraged.

In addition to the common themes and challenges outlined above, respondents reflected upon desirablethe specific, desirable changes for individual stakeholder groups for as diabetes treatment and care to enter into a new, better era of diabetes care.

Commented [c59]: From Simona: Unless we interview

more PWD perhaps the title should be rephrased?

Commented [c60R59]: I think between PWDs and Advocacy interviewed, we have a good representation of the PWD perspective (6/11 external stakeholders represent PWD: Braune, Gabbay, Hauck, Mueller-Wieland, Pall and Phillipson).

Commented [TV61R59]: I understand – the title ‘the perspective of…’ also referred to me as ‘people with diabetes thinking or saying abc’.What we mean here is what interviewees think should change for patients, for systems etc. Is there a better way to express this in English??? It should apply then to all these sub-headings

Commented [c62R59]: There are different possible solutions. A) My suggestion would be to add “advocates” to this heading: “The Perspective of People with Diabetes and Their Advocates”. The following are not as susceptible to misinterpretation. B) Or removing the word “perspective” altogether in this and following headings instances: 1. the person with diabetes 2. the health system 3. Industry: Changing Business Paradigms 4. The Healthcare Professional 5. Regulatory Processes C) Alternatively, we could change “perspective” with “angle” or “viewpoint” or “vantage point”, but I do not think it is as pretty (also considering the following headings – e.g. “the industry angle”)

Commented [JN63R59]: I agree with Carlo’s suggestion (B) above for the 5 subheadings. I would still leave the overall Chapter title as Stakeholder Perspectives on the Future of Diabetes Care. I have now edited the headings accordingly.

12

The Health System Perspective

Experts see the need for health systems to evolve in order to deal with the rising prevalence of diabetes. They also addressed key themes, including 1) clinic function and manpower, 2) information systems, 3) the need for long- term policy and planning and 4) cost funding at every level.

Clinic Function and Manpower

The lack of diabetes specialists is forecast to be a rapidly escalating problem over the coming years across Europe as the number of people with diabetes is expected to continue to increase and potentially overwhelm services. Experts feel that tasks will need to be allocated in a different and better way between allied health professionals, primary care practitioners and specialists, allowing the latter group to focus on prioritized complex cases. Clinical care will also shift away from individual clinical care towards population health.

The coming decade will be about the healthcare workforce, where there will not be enough practitioners and clinical specialists to cope.

Lack of Electronic Health Records as an Obstacle

An effective population approach requires an adequate electronic health record, which is currently lacking in many regions in Europe. One expert stated the need for a single European electronic health record. Another stated that integration is the common denominator and crucial point for future IT systems. There should be a single platform for the download of any and all devices. The same system should be shared by all healthcare stakeholders – above all, by people with diabetes.

Annual budgeting and 4- year governmental cycles simply are not fit forsuited for diabetes management.

Policy Planning and Timescale

Political cycles are too short to allow strategic planning for diabetes. Providing the right policy framework to create the virtual diabetes clinic needs a strategic long-term view over decades. This, in turn, should focus on outcomes and not clinical processes. This is the main political task.

Costs

The current costs of diabetes are unsustainable. A future approach to proper fundingcosts of care needs to be viewed more as investment, with emphasis on value- based care. More work is required to assess the costs and benefits of telemedicine, as well as to clarify assess and predict reimbursement of care delivered by telemedicine. A critical component of the cost debate in the next decade will be efforts to address prevention of diabetes in high risk people who have reversible pre-diabetesthe reduction of risk of developing T2D in those at risk..

Systems are spending a lot of money on the consequences of diabetes because intervention is takes place too late. We need to shift resources to prevention and into the early stages of disease progress.

Commented [TV65R64]: Agree

Commented [c64]: Brigitte suggests changing “cost” to “funding”

Commented [c66]: Brigitte suggests changing “costs” with “funding”

Commented [TV67R66]: agree

13

The Industry Perspective: Changing Business Paradigms

Interviewees focused on the role being played by both the medical technology and the pharmaceutical sectors in the digital transformation of diabetes care. Roles are changing and the sectors are moving closer together with some shared goals. Both sectors aim at offering value and not just new products. Several experts stated that there has been a false dichotomy between the two sectors and that they will increasingly merge in the field of diabetes.

Providing Leadership

Interviewees across the spectrum agreed that iIt is industry and not the clinical world that is currently leading the digital transformation of diabetes care. Furthermore, it is expected thatThe healthcare systems will increasingly adopt a value-based approach, where digital care will become a significant factor and wherewith industry supportsing an increased patient focus.

Safety, Quality, Access

Almost unilaterally, respondents highlighted a speed gap between industry developments on one side and adoption rates on the other. Expert views underscored that EU regulatory frameworks must be able to ensure the availability of safe technology at high quality to people with diabetes without sacrificing innovation and technological breakthroughs. The newly adopted medical devices and in vitro diagnostic medical devices regulations which are currently implemented across Europe are an important pillar of this necessity.

Another challenge is around financing and ensuring access to services and technologies. Diabetes has unfortunately been relegated to the category of a common disease, with payers and purchasers taking a penny-pinching approach to financing (in contrast to cancer, for example). The development of a more personalised approach to diabetes care based on the sub-classification of the disease, risk and treatment options will help. The use of big data will enable a truly value- based approach, as it will identify who responds to treatment and monitor adherence. With this approach, there should be a parallel differential approach to reimbursement and other business models, such as procurement for innovation based on value in the longer term, whilst in particular real-world evidence is still being generated.

Partnerships and Convergence of Sectors

There are many reasons why the convergence of solutions from different industry sectors makes sense. The Covid-19 pandemic could accelerate this process towards higher collaboration and integration based on value- based care and accountable care. Partnerships that integrate medical technology, pharma and information, communications and technology solutions, with a clear focus for patient journeys and developing holistic care, will be the most successful.

Clinical Research

The virtual environment for most clinical care will create the need for significant adaptation in how clinical research is organised. The data quality standards required for clinical research and clinical trials are significantly more stringent than for usual clinical care. Questions arise on how to assess laboratory results and real-life evidence, how to monitor adverse events and how to adjudicate them when most contact is virtual. Recruiting patients for clinical research will be a new challenge. It was stated that this challenge will create the need to develop new best practices for research and to maintain study integrity.

New Industry Players

Innovation is continuing at a rapid pace. Tech monitoring and digital devices may play a much bigger role in the future of diabetes care. Furthermore, private companies outside the traditional health technology sectors can will enter the diabetes field and demonstrate success (e.g. Livongo, Babylon Health, Orbimed, Janacare). In the future, sectors in the areas of food or gaming may will also become value-adding partners in digital diabetes care.

Commented [c68]: From Anja: Can this be worded

differently? Or clarified that this is the view of the

interviewees (incl non-industry representatives)?

Commented [c69R68]: Given the flow of the paper I think this is clear, but we could say: “interviewees across the spectrum agreed that it is industry and not the clinical world that is currently leading the digital transformation of diabetes care

Commented [TV70R68]: Agree. Furthermore, I did not see the link between the two sentences and tried to create a meaningful one.

Commented [TV71]: Not sure I understand this sentence?!

Commented [JN72R71]: This is simply stating that data recording, verification and quality assurance are much more rigorously controlled in clinical trials than in usual clinical care. We can discuss how best to express this.

Commented [TV73]: I would feel more comfortable with ‘may’ – we have now reference that this is a fact.

Commented [JN74R73]: This was an edit suggestion from Lutz Heinemann. We can discuss.

14

The Healthcare Professional Perspective

The major highlights for change by 2030 with regards to the healthcare professional include:

• Care will move from the single clinician to a team-based approach (with allied health professionals)

• Care focus of the clinician will shift from the individual to the population

• Care will shift in 80% casesof consultations from in-person visits to telemedicine (the virtual clinic)

Technology can will have profound impacts on the relationship between healthcare professionals and people with diabetes. As virtual care will become more prominent, diabetes could be managed by algorithms, meetings with patients will move to virtual environments empowered by data. This will lead to a change in the doctor-patient interaction, ideally with equally informed patients and doctors. Both will have access to the same data and data interpretation by AI.

Better Use of Specialist Time and Expertise

Specialists will be able to focus on problem-solving in more complex cases, including the 20% in-person and non- telemedicine consultations. The specialist role is changing, with a greater emphasis on consultation, supporting networks of primary care, managing clinical quality, and seeing more complex cases that require personal intervention. The specialist, rather than managing patients one by one, will provide a sort of concierge service e.g. able to support up to 200networks of primary care clinicians. The specialty of diabetes itself is evolving to better address the complications and closely related clinical patterns that are diabetes ‘adjacent’ like obesity and non-alcoholic fatty liver disease. Cardio-metabolism is a new and developing medical specialty, recognising the significance of vascular complications in diabetes treatment and the need to prevent them.

A Digital Front Door to Better Outcomes

The current divisions between primary, secondary and specialist care will disappear if the new system is integrated based on a common electronic health record. One respondent described this system as a ‘digital front door’ between primary and secondary care. Such a system offers real-time feedback for after each clinic consultation and in each setting. This allows benchmarking for all clinical parameters, including HbA1c, BPblood pressure, cholesterol, etc., as well as for patient satisfaction. This allows real-time adjustment and correction for weaknesses. Such a system will rely on common agreements between all participants on clinical and non-clinical outcomes. Steno Diabetes Center Copenhagen and Diabeter in the Netherlands are European examples of this approach already in action, where clinical care is guided by common agreement on targets and outcomes.

Attracting Talent

There is a fear that talented clinicians will not see diabetes as an attractive specialty choice. Precision medicine and new technology technological options could make it a more attractive speciality, however. To support these developments, there will be a need for much more specialised training for nurses, doctors, and allied health professionals who work in diabetes care.

Commented [TV75]: I understand it will not only be ‘AI’ making this happen, but any accessible data platform.

Commented [TV76]: Why is that deleted? The link to primary care feels important. Can we say, linking more closely with primary and other specialist care.

Commented [JN77R76]: This was from Lutz H. I think he felt there was repetition. I prefer to keep the original sentence

Commented [JN78R76]: I have now restored the original phrase.

Commented [TV79]: I understand those would not only be primary care clinicians but could be other specialties.

Commented [JN80R79]: Yes, so I have left it as ‘able to support networks of clinicians’. This could be e.g. cardiologists, nephrologists, neurologists etc. all who contribute to the care of PWD.

Commented [TV81]: Very important addition!

15

The Regulatory PerspectiveProcesses

Regulatory frameworks for processing data will need to evolve and speed up to realise the digital transformation of diabetes care by 2030. The EU data strategy and the initiative for a European Health Data Space are pointing in the right direction. These frameworks need to provide rules applicable and relevant for healthcare. They need to ensure legal clarity for all actors, and avoid overlap with existing legislation, such as the new regulatory frameworks for medical devices and in vitro diagnostics or the EU General Data Protection Regulation (GDPR) rules, which all already include key elements of regulating ‘digital elements’. The Covid-19 crisis could be a catalyst to accelerate the response to these open questions regarding data and digital transformation.

There is a need for increased expertise on digital solutions among regulators both in the pre-market phase (e.g. before a product or solution is available on the market (for CE marking) for the CE marking of medical technologies) and the post-market phase, when the product or solution is already available on the market (for deciding decisions on access). It is also crucial to consider the correct attitude to risk mitigation and ultimately what degree of uncertainty is acceptable for a given technology application. Regulators of other global regions such as the US have paved the way to embrace digital health, and regulators in Europe EMA need to do the same.

This also applies to the work of Health Technology Assessment (HTA) authorities, as some respondents interviewees were critical of their level of independence and objectivity.

Many respondents see the future of regulatory processes relying on at least the following elements:

• Real-world data used in combination with – not replacing—randomised control trials

• Interoperability of systems through standardization and/or a robust electronic health record

• Ensuring security and privacy

• Misuse of data being punishable by law

There are some promising models of political action that embrace digital care. One of these is the reform of the German health system in 2020.

2) https://www.bundestag.de/dokumente/textarchiv/2019/kw45-de-digitale-versorgung-gesetz-664900

3) https://www.bundesgesundheitsministerium.de/digital-healthcare-act.html

Commented [c82]: Brigitte: “ for deciding on access”---

-should be “for decisions on access”

Commented [c83R82]: adjusted

Commented [c84]: Anja: Can we explain this?

16

Looking Ahead & Recommendations

The Covid-19 crisis has accelerated progress towards digital, interconnected diabetes care and has highlighted the need for a future diabetes service to better match the individual needs and circumstances of people with diabetes. The viral pandemic should beis a turning point in healthcare delivery, marking the end of the routine clinic appointment for chronic medical conditions like diabetes. The current system, where only a tiny fraction of time is spent with a diabetes specialist, seemsis seen as outdated and inadequate to meet the expectations and needs of people with diabetes today. A digital transformation allowing for connected and integrated care with the patientperson with diabetes, rather than the clinic setting itself, is achievable. To succeed in the longer term, however, it the digital transformation will need to be supported by electronic health records and common, shared data platforms, as well as by appropriate financing models that embrace digital, patient-centric, integrated care solutions and approaches. The inputs from a wide spectrum of stakeholders and leaders in the field has been striking in the level of agreement on these key points.

The main caveat for this vision of future care is that inequalities due to poverty, socio-economic factors and lack of education could limit the impact of virtual diabetes care. Many people do not and may not in the future have the financial and non-financial resources to interact digitally – resulting in a digital divide in the population.

What are the main recommendations for the future?

1. Validate the experience of telemedicine during the Covid-19 pandemic

The shift to remote consultations and telehealth during 2020 has been rapid and widespread. Despite the background stress and worries about Covid-19 infection, many positives have been reported both by people with diabetes and healthcare practitioners. The different impacts of these changes need to be documented and studied. Data will become available on many positive aspects of this experience, from resource use, clinical parameters, short-term outcomes, economic costs through to customer satisfaction. It will be crucial for future policymaking to document and validate this experience in Europe.

2. Engage people with diabetes at the forefront of policymaking and service development

It has become increasingly clear that people with diabetes can have a major input to policymaking and to the design of a future clinical service. By sheer numbers (one in ten people in Europe have diabetes) people with diabetes have a powerful public voice and potential influence on political decisionsticians. A future diabetes service that is more egalitarian and customer-focused is now within reach, where the care provided is based on need and can respond to individual changes in real time. People with diabetes should also be empowered further to stimulate innovation by having their demands and expectations heard heard in regulatory processes.

3. Clearly articulate the case with policymakers for future diabetes care, based on data, outcomes (rather than process) and value

The diabetes community needs to articulate its case very clearly for digitally enabled transformation of care. The costs of complications such as myocardial infarction, stroke, amputations, and kidney failure are all largely preventable, and the diabetes world must be much more assertive on this to shift the agenda from other areas of healthcare that currently attract political attention and funding. The type of data and IT infrastructure needed to provide excellent diabetes care are relatively simple and pragmatic, and they should be clearly explained in policy development.

The future vision for excellent diabetes care rests upon the needs of people with diabetes, the availability of necessary data to people with diabetes and clinicians and to people with diabetes of necessary data in a fully integrated system, and on supporting technologies that allow for autonomy, precision, and personalised care. Instruments like value-based healthcare, as well as appropriate up-to-date financing models, are furthermore indispensable for making people-centric, integrated and digitally- enableddigitally enabled care a reality in what is hopefully the near future.

Commented [c85]: Anja: The Recommendations seem very high level (and as such not new). Perhaps they could be a bit more precise on what is needed and who has a role to play?

Commented [c86R85]: I don’t see the recommendations as generalist. #2. perhaps could point to who has a role to play. One theme that was consistent across interviews was on speeding up the regulatory processes. Maybe we can tie this to PWD expectations / demands, and their involvement in those processes?

Commented [TV87R85]: Speeding up, can be a difficult sword. I would not go there. Involving patients is a good idea to me.

Commented [c88R85]: See suggested addition in recommendation #2

Commented [JN89R85]: I am conscious that this document should reflect what has come through in the actual interviews with these leaders in the field (and it does this very well). These recommendations are what have come directly from those interviews. They are quite specific and will be powerful, if they are acted on. The additional wording in recommendation #2 is good.

Commented [c90]: Suggest changing “is” to “should be”? Slightly framing it into a call to action for this section. Otherwise one might read this and think that this will take care of itself. “The viral pandemic should be a turning point in healthcare delivery, marking the end of the routine clinic appointment for chronic medical conditions like diabetes”

Commented [TV91R90]: Agree

Commented [c92]: From Anja: Can this be presented as fact?

Commented [c93R92]: I think this has been addressed.

Commented [c94]: From Anja: by the interviewees?

Commented [c95R94]: I think this is clear. We could take out “is seen” and simply state: “The current system, where only a tiny fraction of time is spent with a diabetes specialist, is outdated and inadequate to meet the expectations and needs of people with diabetes today”.

Commented [TV96R94]: Agree. Perhaps: seems outdated?

Commented [TV97]: Suggest to put PWD first

This project was sponsored by the members of the

MedTech Europe Diabetes Sector Group