The International Diabetes Federation (IDF) is drawing up new guidelines for the treatment of Type 2 diabetes in consultation with a global expert panel. These guidelines are being evaluated, and will be launched in Bangkok in April during the World Congress, said IDF president, Peter Schwarz.
Prof. Schwarz was in Chennai along with the chairperson of the guidelines committee, Antonio Ceriello, (former head of the European Association for the Study of Diabetes – EASD) to give Indian diabetologists a sneak peek into the new set of guidelines.
Speaking to The Hindu, Prof. Schwarz said: “Forming such a guideline is always a big undertaking, because we need to put all the evidence — from science and clinical practice — together. What is unique about the International Diabetes Federation’s guidelines is that it does not lose the science, but makes sure that the practice is applied on to the environment in specific countries. We are talking about putting not the drugs, but the patient in the middle of the care model.”
Prof. Chereillo added: “In many countries in the world, these guidelines are used by healthcare systems to justify some choices in terms of reimbursement or in terms of what can be allowed, how to access care. This is why we we wanted to set the minimum, basic care, that reflects the basic right of anyone with diabetes for treatment; less than this is not acceptable.” While there are multiple guidelines for diabetes in the world, he said most focus on the best available chances because they are coming from the United States or Europe. “But our idea is to give instruments to be used at [a] local level in order to get the best options for the treatment of diabetes.”
The current, or existing guidelines from the American Diabetes Association (ADA) or EASD may not be suitable for all countries, because of accessibility and affordability issues, explained V. Mohan, chairman, Dr. Mohan’s Diabetes Specialties Centre, Chennai. The IDF, which is an organisation comprising over 240 associations of diabetologists across the world, looks at it from a slightly different perspective than national associations for diabetology.
For instance, the ADA’s recommendation that GLP-1 receptor agonists, including semaglutide, may be used as first-line treatment in certain cases “is questionable, for several reasons” said Prof. Ceriello. “I can say that they are good drugs. But there are several problems. Firstly, the shortage of the drugs. In Australia, for example, people were forced to stop because the drug was not anymore available. When these drugs which aid weight loss are stopped, the patients regain weight. So, as part of the guidelines we do not say GLP-1 first, then insulin. We keep insulin as our first choice, and if needed and suitable, you can add GLP-1.”
Prof. Schwarz chimed in: “I’m a strong supporter of calming down to look at the science and the impact. We would move the patient from a lifelong treatment with insulin, which is becoming cheaper and cheaper, to a lifelong treatment with an expensive drug. This has social and financial dimensions and there are side effects – all of which we have to consider.” Dr. Mohan added that there is currently no long-term data on the side effects of the GLP-1 class of drugs, so it may not be advisable to use them as the first-line for everyone at this stage.
Prof. Schwarz added that the IDF is also developing a global diabetes index. “Once a year we will ask 100,000 physician and 100,000 patients in every country in the world about their perception of the quality of diabetes care, and it will be translated into a score of up to 100. Then, immediately, we can compare the quality of diabetes care in Kerala with Wisconsin in the United States. Countries can learn best practices from each other. For instance, he said, the chain of institutions Dr. Mohan runs would be a role model on how to conduct diabetes care in different areas with varying income groups.
Full text of the conversation Prof. Schwarz and Prof. Cereillo had with Dr. Mohan and Ramya Kannan in Chennai.
The new guidelines from the IDF, will these come to govern the way the world handles diabetes?
Peter Schwarz: Forming such guidelines is always a big undertaking, because we have to put all the evidence together – all the information we have from science and from clinical practice.
What is unique about the IDF guidelines? They were formed to examine the basic level of care for diabetes. We don’t want to lose the science, but instead apply the practice onto the environment in countries. This is the challenge and this is what is unique about the IDF guidelines – we take a more the patient centric approach, or putting, not the drugs, but, the patient in the middle of the care model.
Antonio Cereillo: There are so many guidelines in the world, but all are focussed only on the best available chances. Why? Because the guidelines are mainly coming from the United States, from Europe, where these new treatments or technologies are available.
The unique approach of IDF has been to set guidelines to different levels. In many countries in the world, the guidelines are used by the healthcare systems to justify some choices in terms of reimbursement or terms of what can be allowed, how to access care and so on. This is why we wanted to set the minimum, the basic care, meaning that this is the basic right of anyone living with diabetes for treatment; less than this is not acceptable.
Of course, we hope that the basic level will move as soon as possible, very close to the best available, for everyone. But the idea is to give instruments to be used at local level in order to get the best options for the treatment of diabetes.
The idea of the guidelines was the initiative of the former president of IDF, Akhtar Hussain, who passed away a few months ago. It was decided to have a pre-launch of the guidelines in India first, because he thought this country has an open mind, and of course it can be tough sometimes. The entire set of guidelines will be launched in Bangkok in April during the World Congress.
V. Mohan: The existing guidelines from the American Diabetes Association (ADA) or the EASD may not be suitable for all countries, because of accessibility and affordability issues. Take the GLP-1 receptor agonists – no doubt they are very good, but what percentage of people can afford it and in India, since 70% of health care is out of pocket expense and only 30% is from public funds, we need to cater to all.
When the IDF looks at the guidelines,they take a slightly different perspective than the ADA or EASD. It’s not a region, it’s not a continent, they are representing the whole world, so they ask: Can somebody in Rwanda afford this? Can somebody in Bangladesh afford this? What does the research in India say? They have representatives from these countries in the guidelines committee, to share their perspectives from their country-point-of-view as well.
Peter Schwarz: The IDF is a 242-member organisation, all of them diabetes-related and there’s Rwanda and Finland and Myanmar and Surinam, Brazil, Germany in the organisation. That is why we recommend basic care, not minimal care. The model of Dr. Mohan’s Diabetes Clinic is a model which is also represented in the guidelines – you have the diabetes center here delivering the best available diabetes care, but there’s also a charity that delivers diabetes care in the villages, and the standard of diabetes care is the same in both situations.
Antonio Cereillo: Let me underline that the panel of experts is truly global, the members come from all around the world, bringing the specific expertise, and experience which is different from others’. I want also to stress that all the recommendations are not only for best case – this is easy, but it is for basic care.
The guidelines are also very modern, we have the advantage to be the latest, we are only able to incorporate the evidence available until, let’s say, more or less, yesterday. For instance, there is a recommendation to use when needed, immediately, a combination, not to wait to scale up step-by-step treatment.
The ADA has recommended the use of GLP-1 receptor agonists as the first line in certain cases. Is this something of a radical move. What is the IDF’s view?
Antonio Cereillo: This is questionable, for several reasons. Of course, I can say that they are good drugs. But there are several problems; firstly, there is a shortage. In Australia, people were forced to stop because the drug was not available anymore. And then you have a disaster because when these drugs are stopped, people regain weight.
Secondly, there are several problems in terms of side effects – the quality of life is questionable because people have reporting nausea, vomitting, not being able to enjoy food, for example. There is also the cost angle, the price is exhorbitant.
So our position is that it is not mandatory that this is the first line drug of choice for patients. Of course, if you have obese patients, you must consider it; you must consider if there is a really high risk for cardiovascular disease, But we keep insulin as our first choice, and if needed, you take the GLP-1. Theser are good drugs, but cannot be used for everyone.
Peter Schwarz: From the perspective of the IDF, we totally understand that everyone is excited about these new drugs and they are fascinating drugs. I’m a strong supporter that we calm down and look at the science and the effects. We would be moving the patient from lifelong treatment with insulin, which is becoming cheaper and cheaper in the world, to life-long treatment with an expensive drug.
This has financial and social dimensions, and there are side effects to consider. At the end, it’s an individual decision of the physician interacting with the patient. But GLP-1 is not always the right answer.
V. Mohan: We don’t have long-term evidence, as these drugs have been around only for a few years now. Whereas the other drugs have been around for years – metformin, have been around for 60-70 years, and the DPP-4 inhibitors and SGLT-2 inhibitors have been there for more than a decade now. Some of the side effects come much later, not necessarily initially, particularly if they are rare. If the side effects are rare, you won’t see it manifest in a trial of 5000 or 10,000 people, but when a million people are using it, they crop up.
On International Diabetes Day (coming up on November 14)
Peter Schwarz: Often as healthcare professionals, we only look into the diagnosis and pharma treatment and management of diabetes and outcomes and we sometimes forget the needs of the patients, the quality of life of the patient, and the well-being of the patient. 80% of our patients have already reported burnout due to diabetes. 75 % asked for help to get support on social level on quality of life and well-being level due to diabetes. I think this is something that has to change in the future and this is 2024’s World Diabetes Day message.
So everyone was seeing this or everyone listening, I would like to call for action – something you can do in a small way in your environment and for your friends, for your family, or if you are a physician, maybe a larger step to improve well-being for people living with diabetes or a big step if you are stakeholder or politician or policymaker to think about how to reshape policies, guidelines, clinical practice, recommendation, pointing out that the patient is in the centre of our care.
The well-being or quality of life in people living with diabetes is something we not only have to consider, it should be right at the centre. You may follow the IDF to see the activities or follow the different activities of the diabetes organisations across the world.
We’ve been speaking about treatment, prevention, etc. So for years now there’s also been a demand to have ethnicity or country specific diagnostic parameters. What is the idea of view on that?
I would say that with diabetes itself, there are no big variations globally, but there are differences and for example, the kind of diabetes you find here in India is different than it is in the population in Europe and the US.
So diabetes here starts earlier, and I learnt from Dr. Mohan that it is common in females and persons with low BMI (body mass index). So the people who get diabetes here are slim, young, female and mostly type 2 diabetes, while in Europe and they are 25 years older and have a much bigger BMI.
You could ask why is this different, but I would argue it’s not a different kind of disease, but the pathophysiology leading to the disease here is different. And one of the reasons could be higher consumption of fried carbs. So if you fry carbs a higher temperature, you generate bonds between fat and glucose. Our body cannot metabolize it, and it’s stored in the liver. And today we know from a scientific point of view that the increase in liver fat is one of the strongest indicators for getting diabetes.
So the disease is similar, but the risk factors because of the environment is different. At the end it is important for colleagues working in the field to understand the pathophysiology, the risk factors of the disease in the enviroment and evaluate if it is a fast-growing risk or a slow growing risk. They then have to decide what is the right approach.
What is also interesting, is that if you have a person with diabetes in Europe and the pre-diabetes period is 7 to 10 years, while here in India, it’s 7 to 12 months. This makes the challenge in terms of diagnosing early enough.
Digitalisation and artificial intelligence, in my eyes, provide brilliant new opportunities. If we have to diagnose early, using tools on smarphones that can detect biomarkers digitally, and predict risk early. The smartphone can also, with providing impulses to influence lifestyle, can support them for a healthy lifestyle.
Of course, my heart beats for prevention, prevention, prevention. The earlier we find risk factors the better it is for the patient. In the future, the the amount of fat in the liver could become one of the early markers of risk, but professionals should be aware.
The IDF will build a fellowship program for healthcare professionals. There are 1.2 million healthcare professionals treating people with diabetes in the world, we will get some of them and provide them with the latest updates as far as professional education goes. So the goal is that the colleagues in India, in Congo and in Finland can have the same source of professional. diabetes education.
V. Mohan: For diabetes, for glucose levels, I don’t think there’s any difference across the world. The only thing where the WHO has indicated different measures is for obesity. Using the western definition for obesity would be a BMO of 30. In India, the risk starts at a much lower BMI. So the WHO has fixed South Asian, Asian and Indian guidelines at much lower rates. 23 and above is overweight and 25 and above is obesity.
Another guideline that was developed to aid early detection was using the one-hour value during a glucose tolerance test. If the one hour reading was abnormal, it indicates a pre,pre diabetic stage and if you catch them there it’s much easier to reverse them to normal. If you can do continuous glucose monitoring (CGM), that’s the next step, it would help pick up the signals.
Antonio Cereillo: The next step is the CGM. We are waiting for the cost of the monitors to drop, just as it happened with mobile phones. It is affordable too. The CGM will be able to provide a real glycaemic picture in daily life. Then you can really understand if the person is at risk or not.
Peter Schwarz: The IDF is already starting a new process. And let’s say in about 1.5 to 2 years, there will be a clinical practice recommendation about fasting and diabetes. About 200 colleagues are already coming into a group together, from across the world, including from India, to discuss fasting. They will be discussing 19 different models of fasting in diabetes – including the intermittent fasting model, religiously-driven fasting model and purely agnostic models of fasting – directed towards examining how a patient with diabetes mellitus can benefit from them.
Fasting is not costly, you actually save money, and it is something everyone can do, anywhere. We will come up with all the evidence for patients, for healthcare professionals, for the scientific community – what kind of fasting works for what type of persons in what stage of the disease and what the benefits will be.
What about personalized medicine? Has it gained ground for diabetes?
Antonio Cereillo: Personalised medicine always is like a compromise between the best and what is achievable in terms of contract between the physician and the person living with the disease. The basis remains the evidence, the science -that must be adapted to the person.
Peter Schwarz: I would like to raise a lot of awareness to this topic of personalized medicine. What we sometimes forget as physician, we are not treating glucose. We are providing the support for the patient, this might include medication for a disease. We are talking to the person, we have to understand their needs, their well-being and quality of life, and then together with the patient, we make a treatment recommendation. Drugs are only one step in the portfolio of tools we have for the care of people with diabetes. It also includes behavioral intervention, nutritional intervention, education.
Digitalisation is a brilliant way to personalise intervention because our smartphone learns our behavior, through artificial intelligence. Using the learning through the smartphone to translate this into a lifestyle intervention for the individual.
In a region which has the highest burden of diabetes, is there something more that the governments can do than they are doing right now?
Peter Schwarz: There are a lot of aspects where you can improve the quality of diabetes care. What the IDF will do is develop a global diabetes index. So once a year we will ask 100,000 physicians and 100,000 patients in every country about their perception of the quality of diabetes care, and it will be translated into a score of up to 100. Then, immediately, we can compare the quality of diabetes care in Kerala with Wisconsin, U.S.
We want to build momentum to motivate stakeholders, healthcare professionals and politicians. But the answer as to what they can do, I think it this has to be taken in the country, the IDF cannot tell what is the biggest barrier in Myanmar, but what we can do is develop role models to say this aspect was solved in this country and then distribute these role models
For instance, the chain of Dr. Mohan’s diabetes centres, is a role model showing how to connect diabetes care in different areas with varying income levels.
Antonio Cereillo: In my opinion that there is one simple, apparently simple action – to convince politicians that if they invest today, they will be spared tomorrow, But it never works because you know politicians do not last. To implement this, the politicians should be convinced that this is a good investment, which may not pay now, but will do so in the long term.
V. Mohan: So in India, the execution is at the State level because health is a state subject. Here, in Tamil Nadu the government has started a new scheme where they don’t wait for the people to come to the hospital, instead they go to the homes regularly, ask patients questions about check up, testing blood levels, and providing awareness about complications.
Tamil Nadu also first started providing children in schools with noon meals. took the example first, improving education and nutrition. Now they have started giving break fast as well. These are things that might be copied in other States.
Can you name one innovation in diabetes that has changed, or will change, it on its head?
Peter Schwarz: Making CGM glucose sensors much, much cheaper than they are today and invest in digital diabetes intervention using smartphone for awareness, prevention and better care.
Antonio Cereillo: Diabetes is one of the diseases that has really had a lot of advancements in the last few years. When I graduated, we had three drugs. Now, not only we have a lot of drugs, we have the possibility of having continuous glucose monitoring, insulin pump, artificial pancreas is at the corner. So really, today hoever has this problem has a very good chance to live longer and well.
V. Mohan: CGM of course would come right on top with mobile phones and using technology. The insulin pumps, with the AI built in, with hybrid closed loop systems have also changed the life of Type 1 diabetes patients by managing hypo- and hyperglycaemia episodes efficiently. Cost is still a factor, but it has been a complete game changer for this set of patients.
I think the cure for diabetes is not far away. We’ve already started seeing the first trials of islet cell transplantation and stem cell-derived islet cells. The day may not be far off when Type 1 diabetes may be completely cured, Type 2 diabetes is not going to go away in a hurry as long as obesity is there, but better and better control of diabetes is possible.
We’re never going to achieve a diabetes-free world or India. In fact, we’re going to live longer and we’re going to have a lot of senior people living with diabetes. But we can have a complication free world, where there is no blindness, no kidney failure due to diabetes, no impotence due to diabetes.
So I think better days are yet to come.
