What is type 1 diabetes?
Type 1 diabetes is an autoimmune disease. This happens when the immune system, which normally fights off viruses and bacteria, is directed against the body instead. In type 1 diabetes, the immune system attacks and destroys insulin-producing “beta cells” in the pancreas. Our body needs nourishment in the form of sugar in ingested food. Insulin is a vital hormone that transports sugar from the blood into the cells. If the body cannot produce enough insulin, sugar will accumulate in the blood after a meal. This can lead to serious health issues. People with type 1 diabetes must therefore take insulin injections for life in order to avoid these health problems.
What is newborn screening for the risk of developing type 1 diabetes?
It is an early detection method for type 1 diabetes. Type 1 diabetes is a genetic disease that occurs primarily in people who have certain high-risk genes. About 1% or 10 out of every 1,000 children have high-risk genes for type 1 diabetes. However, this does not necessarily mean that they will all get the disease. 10% of these children with high-risk genes will develop early type 1 diabetes by their sixth birthday.
Research results from recent years suggest that there is a time window in babyhood and early infancy in which the autoimmune reaction and thus the disease type 1 diabetes can possibly be prevented. To be able to act during this period, however, one must know beforehand whether there is an increased risk of type 1 diabetes.
Parents living in Oxfordshire, Berkshire and Buckinghamshire can agree to have their child tested for the increased risk of type 1 diabetes free of charge. Your agreement for this will be sought during your pregnancy or just after she or he is born.
Only a few drops of blood are required for this, which are taken during regular newborn screening.
If your child has an increased risk, we will invite you and your child to participate in the POInT study, which is designed to help prevent the development of type 1 diabetes
What does an increased risk of type 1 diabetes mean?
In the general European population, the risk of developing type 1 diabetes is 1 in 250. There are at least 50 gene regions in the human genome that are associated with an increased risk of developing type 1 diabetes. In the POInT study, we are investigating some of these genes. The result is used to calculate a risk score. Blood analysis will identify infants whose risk is ten percent or higher.
Who can participate?
Genetic screening for the risk of developing type 1 diabetes can be carried out quickly, safely and easily for children in Oxfordshire, Berkshire and Buckinghamshire as part of regular newborn screening in the first days of life.
What are the advantages of participating?
If the newborn screening reveals that your child has high-risk genes for type 1 diabetes, we will invite you and your child to participate in the POInT study. The aim is to train the immune system with insulin powder, which is ingested with food, and to help prevent autoimmunity from attacking insulin-producing cells. This way, we may find a way to prevent the development of type 1 diabetes.
Are there costs involved?
Participation in the INGR1D genetic screening for type 1 diabetes is free.
What do I need to know about the blood test?
The early detection of diabetes risk takes place together with the regular newborn screening. The doctor will take a few drops of blood from your child’s heel and drop them onto filter paper cards for screening. Alternatively, umbilical cord blood or venous blood may also be used. Blood tests pose minimal danger or risk to your child. There could be a small bruise, swelling or infection. However, the risk of infection is very low.
How will I know if my child is affected?
If your child has type 1 diabetes high-risk genes, you will be contacted and advised by us within 16 weeks of blood test.
Who organizes and pays for the studies?
The INGR1D and the POInT studies were initiated by GPPAD, the Global Platform for the Prevention of Autoimmune Diabetes. GPPAD is an association of several academic research institutions and clinics in Europe. Helmholtz Zentrum München is responsible for coordination. In the UK, these studies are organized by the University of Oxford. Both studies have been approved by the responsible regulatory authorities.
The Leona M. and Harry B. Helmsley Charitable Trust, based in the United States, funds the INGR1D study and POInT. The Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Among other efforts, it supports research in the field of type 1 diabetes.
What happens to my and my child’s data?
We will be using information collected from you, your child and your and your child’s medical records in order to undertake this study. Research is a task that we perform in the public interest. The University of Oxford, as sponsor, is the data controller. This means that we, as University of Oxford researchers, are responsible for looking after your information and using it properly. We will only use the minimum personally-identifiable information possible. We will keep identifiable information about you and your child until the end of the study, when it will be disposed of. We will store the de-identifiable research data and any research documents with personal information, such as the completed consent forms, securely at the University of Oxford for 21 years from when the last study participant is recruited.
Your rights to access, change, or move your or your child’s personal information may be limited, as we need to manage your and your child’s information in specific ways in order for the research to be reliable and accurate. You can find out more about how we use your information by contacting INGR1D@wrh.ox.ac.uk
The de-identifiable data from this study will be included in a worldwide database to help the research community tackle diabetes in future (see www.gppad.org for more details). Data access will be protected by password and via a secure, encrypted connection in all cases. Only members of the research consortium will be able to access the data.