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Freder1k Study

Dear Parents,

On this page, we answer important questions about the Freder1k newborn screening, where we test children up to the age of six weeks for an increased risk of type 1 diabetes. If an increased risk is detected in your newborn, we invite you to participate with your child in the AVAnT1A study for the prevention of the disease. This study investigates whether a COVID-19 vaccination at the age of six months can prevent the development of type 1 diabetes.

Dear Parents,

On this page, we answer important questions about the Freder1k newborn screening, where we test children up to the age of six weeks for an increased risk of type 1 diabetes. If an increased risk is detected in your newborn, we invite you to participate with your child in the AVAnT1A study for the prevention of the disease. This study investigates whether a COVID-19 vaccination at the age of six months can prevent the development of type 1 diabetes.

Between the second and third day of life, newborns are checked for treatable metabolic and hormonal disorders as part of the standard newborn screening tests. In the following, we would like to draw your attention to another free, additional screening test for babies for the early detection of an increased risk of type 1 diabetes, which is an autoimmune disease. The test is carried out by a doctor as part of the Freder1k study. It can take place together with the standard newborn screening or separately, within the first six weeks after the baby is born.

Participation in the Freder1k study is optional and free of charge!

Parents whose children are found to be at an increased risk of developing the disease are given detailed information on the result and what this means for their child in a personal consultation. They are also asked if they would like their child to take part in the AVAnT1A study that potentually aims to prevent the disease.

Type 1 diabetes is the most common metabolic disease in children and adolescents. People with type 1 diabetes have insulin deficiency. Insulin helps transport glucose from your blood into your cells. Children with type 1 diabetes must therefore be treated with insulin for life. One difficult aspect of type 1 diabetes is that it is usually only recognised when the person affected already has serious and sometimes even life-threatening symptoms. Conversely, if children at risk of type 1 diabetes are identified early, families can be offered counselling and regular follow-up checks so that, if the disease develops, it can be detected and treated at an early stage. They may also be able to participate in studies that aim to prevent the development of the disease.

You can find out whether your child is at increased risk of type 1 diabetes as part of the Freder1k study.

Type 1 diabetes primarily develops in individuals who have an increased risk of the disease due to the presence of certain genes. The majority of children who are at increased risk and develop type 1 diabetes do not have relatives with the disease. So type 1 diabetes can affect anyone. In our screening test we check whether your child has an increased risk of developing type 1 diabetes.

Parents in various European countries (Belgium, Germany, the UK, Poland and Sweden) can have their children tested for an increased risk of developing type 1 diabetes. In Germany, the screening test is available free of charge in Bavaria, Lower Saxony, Saxony and Thuringia as part of the regular newborn screening in the first few weeks of life or – currently only in Bavaria and Lower Saxony – as part of the standard screening test (U2) or any other paediatrician visit for babies up to six weeks old. Infants all over Germany whose parents or siblings have type 1 diabetes can also take part in the screening test – and this opportunity is also for babies up to six weeks old.

The risk of developing type 1 diabetes is determined by testing a few drops of blood obtained from the umbilical cord or from a small prick in the baby’s heel just after birth. The drops of blood are placed onto specimen collection paper. Your baby should not be more than six weeks old at the time of screening. 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.

You will not be contacted if the test result is normal. This means that no news is good news. If you have not heard from the Institute of Diabetes Research, Helmholtz Munich within three month of the test, you can assume that your child does not have a high risk of developing type 1 diabetes. If you are still unsure, you can contact us to ask whether your child has an increased risk of type 1 diabetes.

If the screening test shows that your child has an increased risk of type 1 diabetes, you will be contacted by the Institute of Diabetes Research, Helmholtz Munich. We'll invite you to a one-on-one consultation to thoroughly explain the results and their significance. During this session, we'll also discuss the possibility of your child participating in a study aimed at preventing the development of type 1 diabetes.

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.

Take advantage of this opportunity: have your child tested for the risk of developing type 1 diabetes so that they can receive preventive treatment if needed.

6+ good reasons why you should take part in the Freder1k study:

The Freder1k study...

  • ... tests your child for an increased risk of type 1 diabetes, the most common metabolic disease in children and adolescents.
  • ... identifies the one child in 100 children who is at increased risk of type 1 diabetes.
  • ... enables families affected to participate with their child in prevention studies that aim to prevent the onset of type 1 diabetes.
  • ... helps with early detection of type 1 diabetes in children with an increased risk through follow-up testing between two and ten years old.
  • ... provides affected families with comprehensive advice.
  • ... helps reduce any fears and uncertainties about type 1 diabetes for families affected.

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

We are working on developing new treatment approaches in the early stages that aim to prevent the disease or at least delay its onset. Find out more about our prevention studies:

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 old were recruited into 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. The POInT Study investigates whether the administration of insulin powder in the first two years of life has a protective effect on the immune system. The POInT study will be successfully completed by mid-2024.

Participants in the SINT1A Study receive a probiotic in the first two years of life, which aims to positively influence the microbiome and thus prevent autoimmune reactions. Since March 2024, participants in the SINT1A Study have been fully enrolled.

Following the POInT Study (Primary Oral Insulin Trial) and the SINT1A Study (Supplementation with B. INfantis for Mitigation of Type 1 Diabetes Autoimmunity), AVAnT1A is now GPPAD's third intervention study aimed at developing new preventive measures for type 1 diabetes.

Read more about the AVAnT1A study.

 

About the Global Platform for the Prevention of Autoimmune Diabetes:

GPPAD is a European platform that identifies children at increased genetic risk for type 1 diabetes and conducts studies on primary prevention. The aim of the studies is to reduce the occurrence of islet autoimmunity and type 1 diabetes in children. GPPAD research centers are located in Belgium (Leuven), Germany (Dresden, Hannover, Munich), Poland (Warsaw, Łódź), Sweden (Malmö), and the United Kingdom (Newcastle, Cambridge). The research platform is financed by the Leona M. and Harry B. Helmsley Charitable Trust.

Would you like to know more?

If you have any further questions, please feel free to write to us. Our study cooridnator Manja Jolink (manja.jolink@helmholtz-munich.de) is there for you.

Contact

Porträt Manja Jolink

Manja Jolink

Study Coordinator Freder1k Study

Heidemannstraße 1, 80939 München