TYPE 1 DIABETES

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Frequently asked questions

What is type 1 diabetes?

Type 1 diabetes is an autoimmune disease. This means that the immune system, which primarily serves to defend the body against germs, attacks the body’s own structures. In the case of type 1 diabetes, the immune system attacks and destroys the insulin-producing cells in the pancreas. Insulin is a vital hormone that transports sugar from the blood into the cells. If the body can only produce little or no insulin itself, the sugar accumulates in the blood. This leads to health problems. This is why people with type 1 diabetes need insulin injections for the rest of their lives in order to manage the disease and prevent complications.

What does the early detection of the risk of developing type 1 diabetes mean?

Type 1 diabetes primarily occurs in individuals who have certain high-risk genes. Approximately 1% or ten out of every 1,000 children have high-risk genes for type 1 diabetes. However, this doesn't necessarily mean that they will develop the disease. For every 100 children with high-risk genes, only about ten of these children will develop an early stage of type 1 diabetes by their sixth birthday.

Research results from recent years indicate that there is a time window in infancy and early toddlerhood in which the autoimmune reaction and thus type 1 diabetes can possibly be prevented. To make use of this period, you need to know in advance whether the child has an increased risk of type 1 diabetes.

This is why, as part of the Freder1k study, all parents living in Bavaria, Lower Saxony, Saxony and Thuringia can now have their children up to four months of age tested for an increased risk of type 1 diabetes free of charge. In addition, babies who have a parent or sibling with type 1 diabetes can participate in the Freder1k study throughout Germany, no matter where they live.

All that is needed is a few drops of blood, which can be taken during the regular newborn screening (in Bavaria, Lower Saxony, Saxony and Thuringia) or during a visit to a doctor (in Bavaria and Lower Saxony).

If your child is at increased risk, we will invite you to take part in the POInT study, which aims to prevent the development of type 1 diabetes. Parents and children who do not wish to participate in the POInT study are given the opportunity to participate in follow-up checks at the age of two. At these follow-up checks, we can identify at an early stage whether your child is actually developing type 1 diabetes. Because the earlier the disease is detected, the faster it can be appropriately treated.

What does an increased genetic risk mean?

There are at least 50 gene regions in the human genome that are associated with an increased likelihood of developing type 1 diabetes. In the Freder1k study, we examine some of these locations and calculate the participant’s genetic risk. In the broader European population, the risk of developing type 1 diabetes is 0.4%. The blood analysis that is part of the Freder1k study identifies infants whose risk is 10% or more. Compared to the population average, these children have at least 25 times as high a risk of developing type 1 diabetes.

Who can participate in the screening test?

The screening test for the risk of developing type 1 diabetes is available for all children in Bavaria, Lower Saxony, Saxony, and Thuringia as part of the regular newborn screening in the first few days of life or at any other paediatrician visit until they reach the age of four months. In addition, children living in Bavaria and Lower Saxony can also be screened for their risk of developing type 1 diabetes as part of the other standard screening tests (U2, U3 or U4). The test is quick, safe and free of charge. Infants all over Germany whose parents or siblings have type 1 diabetes can also participate until they reach four months of age.

What are the advantages of having the test?

If the screening test shows that your child has high-risk genes for type 1 diabetes, we will invite you and your child to take part in the POInT study. The study aims to use insulin powder, which is ingested with food, to “train” the immune system and prevent the body from attacking its own structures, thus preventing the disease from developing.

Independent of this, your child can take part in further tests between the ages of two and ten. If your child develops an early stage of type 1 diabetes, the tests will allow this to be diagnosed in good time so that your child can receive the best possible care and treatment from the outset. This will enable the prevention of life-threatening hyperglycaemia, which can develop relatively quickly and without warning. We provide detailed information and advice to affected children and parents.

Do I have to pay for the screening test?

No. The test is part of the Freder1k study and is free of charge. It is funded as part of the research project.

How is the blood collected?

The screening test for type 1 diabetes should ideally be carried out together with the standard newborn screening tests. The doctor will take a few drops of blood from the baby’s heel. The blood sample is collected on specimen collection paper, so that it can be tested. Alternatively, umbilical cord blood or venous blood can also be used. Taking a blood sample poses no danger to your child. The collection of blood could lead to a small bruise, swelling, or infection, but the risk of infection is very low.

How will I find out if my child is affected?

If your child has high-risk genes for type 1 diabetes, we will contact and advise you within twelve weeks of the test.

Who organises and who pays for the studies?

The Freder1k and POInT studies were initiated by the Global Platform for the Prevention of Autoimmune Diabetes (GPPAD). GPPAD comprises several academic research institutions and hospitals in Europe. Helmholtz Zentrum München is responsible for coordination. The relevant regulatory authorities have approved both studies.

The Helmsley Charitable Trust, which is based in the US, finances Freder1k and POInT. The Helmsley Charitable Trust is a family trust that supports research in the field of type 1 diabetes, among other topics.

Is it possible to prevent type 1 diabetes?

We are working on developing new treatment approaches in the early stages that aim to prevent the disease or at least delay its onset. With the Primary Oral Insulin Trial (POInT) prevention study, our aim is to use “immune training” to prevent type 1 diabetes in children who have an increased risk of developing the disease. Children between four and seven months of age are included in the study. The idea is to get the immune system used to the insulin molecule through daily consumption of a small amount of insulin powder with food, up to the age of three, and thus prevent the immune system from attacking the body’s own structures.

Previous studies have indicated that this training can succeed. However, there is no guarantee.

What happens in the POInT prevention study?

When a child is between six months and three years old, the immune system is particularly sensitive to new stimuli that enter the body via, for example, the digestive tract. During this period, children gain experience with various foods and put many objects in their mouths. As a result, the immune system learns how to deal with a wide variety of structures in the right way. In children with high-risk genes for type 1 diabetes, however, there is increased likelihood that a mistaken reaction by the immune system may occur in exactly the same period. That is why it makes sense to take preventive action on the immune system in the first few years of life and thus protect the body’s own insulin. In the POInT study, our goal is to train the immune system through the consumption of insulin powder and thus prevent the autoimmune process.

If your child is taking part in the study, they will take a powder (insulin or placebo) with a meal every day, beginning between the ages of four to seven months, until the day before their third birthday. We will then continue to observe and screen your child for some time after the treatment, to check for any development of an early stage of type 1 diabetes. In order for a clinical study like POInT to deliver reliable results, it is crucial to divide the participants into two groups. One group receives insulin powder, the other a placebo – a powder that does not contain insulin. The assignment to the two groups is random. Until the end of the study, neither the participants, nor the doctors, nor the study coordinators know who has been assigned to which group.

What indications are there that immune training works?

Initial promising results that training with insulin powder can succeed were found in a preliminary study known as the Pre-POINT study (JAMA 2015; 313(15):1-10. doi:10.1001/jama.2015.2928). Allergy research also provides further evidence that the concept of immune training can work in early childhood. In the published LEAP study, children who consumed peanuts up to the age of five developed a peanut allergy significantly less than the group that avoided peanut consumption (Du Toit G et al., N Engl J Med 2015).

What does participation in the POInT prevention study cost?

Nothing! The treatment and all investigations carried out as part of the study are free of charge, and any travel expenses are reimbursed. The study is financed by research funding.