INGR1D Study in the Thames Valley
INGR1D is a large screening study in the Thames Valley to identify infants who are at risk of developing type 1 diabetes.
ABOUT THE STUDY
In the first week of life, newborns are checked for treatable metabolic and hormonal disorders as part of the standard newborn screening tests. We would like to let you know about the option of another free screening test to identify children at high risk of developing type 1 diabetes. The test is available as part of a research study being carried out by staff of the NHS and the University of Oxford. This extra test can be performed on blood that has already been collected. There are no extra needles or blood tests required for this diabetes screening and taking part is voluntary. For further information, please read our study leaflet.
Type 1 diabetes is a common metabolic disease in children and adolescents caused by insulin deficiency. The deficiency is due to a faulty immune system. The body’s own defence system attacks insulin-producing cells in the pancreas and destroys them. As a result, children with type 1 diabetes require life-long treatment with insulin. 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.
Type 1 diabetes primarily occurs in individuals who have certain high risk genes. Most children who have these high risk genes and develop diabetes do not have any relatives with diabetes. In other words, the disease can affect anyone.
If your child is found to have genes giving an increased risk for diabetes, we will contact you and advise you on the results as well as inviting your child to take part in a prevention study, POInT (Primary Oral Insulin Trial). The aim of the POInT study is to find ways to prevent the disease.
If you would you like to learn more about the risk of type 1 diabetes or preventive treatment visit our FAQ's or contact us using the details below.
The INGR1D Study Team
Nuffield Department of Women’s and Reproductive Health, University of Oxford
The Women’s Centre, John Radcliffe Hospital
Phone: 01865 572258
WHO CAN PARTICIPATE IN THIS STUDY?
Most pregnant woman in the Thames Valley can participate.
Women will be approached in the Ultrasound Dept. of their local hospital when they are due to have a scan, or after their baby is born and before the new born screening test is carried out.
Women who are interested can contact the Research Midwife at their local hospital.
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.
This study has been ethically approved by the Hampshire A Ethics Committee.
Ref number 18/SC/0005