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We have answered some of the most frequently asked questions about INGR1D2 on this page. For more detailed information on what the study involves, please consult our Participant Information Sheet (see right).
09889 - PIS - V1.6 - 2024-04-04.pdf
Which hospitals are taking part in the INGR1D2 study?
Which hospitals are taking part in the INGR1D2 study?
The INGR1D2 study allows parents to test their child for this increased risk free of charge at the same time as the routine newborn blood test. Please click here to find a list of hospitals currently taking part in the INGR1D2 study. All babies identified as being at higher genetic risk of Type 1 Diabetes will be offered the option of taking part in the AVANT1A study.
What is Newborn Blood Spot Screening?
What is Newborn Blood Spot Screening?
Every baby in England is offered newborn blood spot screening, also known as the heel prick test. Newborn blood spot screening involves taking a blood sample to find out if your baby has 1 of 9 rare, but serious, health conditions. Most babies won't have any of these conditions but, for the few who do, the benefits of screening are enormous.
The test is taken at 5 days of age. A healthcare professional pricks the baby's heel with a small needle and collect 4 drops of blood on a special card. Occasionally, the sample may need to be taken when the baby is 6, 7 or 8 days old. Sometimes a second blood spot sample is needed. The heel prick test has been used for many years and doesn't carry any known risks for babies.
INGR1D2 uses the blood collected as part of the newborn blood spot screening test, so babies taking part do not need to have any extra blood tests.
Who can take part in the study?
Who can take part in the study?
The INGR1D2 teams are currently approaching women at participating hospitals from Monday to Friday. If you are approached by one of our researchers, you will be given all the information you need to make a decision on whether to enrol your baby. We will approach any mothers over 18 weeks of pregnancy although the point at which you might be approached may vary between hospitals, and you may be approached after your baby has been born. If you have not yet been approached about the INGR1D2 study and would like to speak to a member of your local research team, please click here to find your local contact details.
The majority of babies will be able to take part in the study; there are only few exclusion criteria. If there is a specific reason that your baby cannot participate in the study, this will be explained to you in full.
Are there advantages to having my child tested?
Are there advantages to having my child tested?
Type 1 diabetes affects 1 in every 250 children born in the UK every year. People with Type 1 Diabetes need to have insulin replacement therapy for the rest of their life, bringing many serious life-long challenges for individuals and their families. Click here to find out more about Type 1 Diabetes. Type 1 Diabetes is currently incurable so our research focuses on finding ways to prevent Type 1 Diabetes from developing in people who are most at risk.
We want to research ways to prevent the things that can trigger Type 1 diabetes in those at risk, long before symptoms develop and insulin treatment is needed. Because Type 1 Diabetes is strongly inherited, we can identify newborn babies at the greatest risk of the disease with genetic testing. This is what the INGR1D2 research aims to do.
About 1 in 100 babies have a higher risk of developing type 1 diabetes later in life. Currently the NHS does not routinely screen babies for their genetic risk of Type 1 Diabetes, so INGR1D2 gives parents information that they would not otherwise have.
Parents of babies who are identified as being a higher genetic risk of developing Type 1 Diabetes are contacted and offered the option for their baby to take part in a further research study called AVAnT1A. AVAnT1A aims to explore a treatment that may reduce the chance of a baby at high genetic risk of Type 1 diabetes from ever developing the condition.
What happens if my baby is identified as being higher risk for Type 1 Diabetes?
What happens if my baby is identified as being higher risk for Type 1 Diabetes?
If your child has high risk genes for type 1 diabetes, one of the study team from your local area will check your child’s health status via their medical records prior to contacting you. We will contact you and your GP (with your permission) within 3 months of the test to provide you with a booklet explaining the test results, and invite you to discuss what this means. Most children with high risk genes will never go on to develop diabetes. We will give you detailed advice and training on how to recognise the symptoms of diabetes, so that if your child does develop these you can seek appropriate help.
You will also be invited to take part in a research study called AVAnT1A (Anti-viral action against Type 1 diabetes autoimmunity). If you would like to take part in AVAnT1A, you will be asked to sign a separate consent form. Agreeing to take part in INGR1D2 does not mean that your baby has to take part in AVAnT1A and you do not have to give a reason why you do not wish to proceed.
The main objective of AVAnT1A is to investigate whether vaccination against CoViD-19 at the age of 6 months can prevent the development of islet autoantibodies in children at increased risk of type 1 diabetes. Only babies who are identified as being at higher genetic risk of Type 1 Diabetes via the INGR1D2 study are eligible to take part in the AVAnT1A study. The INGR1D2 and AVAnT1A studies are designed to work together. The differences and links between the two studies are illustrated in the diagram and flowchart below.
What do parents say about taking part in INGR1D2?
What do parents say about taking part in INGR1D2?
We invite parents taking part in INGR1D2 to give us feedback on their experience of the study by filling in a quick survey. We review the information parents share with us on a regular basis to see what we are doing right and where we can make things better. The survey results show us that people take part in INGR1D2 for different reasons (for example, to get information about their baby's risk of Type 1 diabetes or to help others through research). Most parents rate their experience of taking part in INGR1D2 very highly. They say that research staff are friendly and knowledgeable, and that there is no pressure to take part. The video below shows some of the comments parents have left about the INGR1D2 study. You can also read about the experiences of Billie, a mother who enrolled her baby in the INGR1D2 study here .
Billie Clayton and her daughter
What research has already taken place in this area?
What research has already taken place in this area?
In the first phase of the INGR1D2 study, babies who were identified as being at risk were invited to take part in a further study called SINT1A. The SINT1A study investigates whether giving the probiotic B. infantis can prevent the development of type 1 diabetes in children with an increased risk of type 1 diabetes. In the study, the probiotic is given orally (by mouth). The aim is for this to positively influence the intestinal flora and thus have a regulating effect on the immune system. In the study, the aim is to investigate whether this can reduce mistaken and pathogenic immune responses, such as those in type 1 diabetes, as well as other diseases, such as celiac disease.
Parents of babies who have taken part in SINT1A have said:
"The staff are phenomenal - their knowledge and ability to explain key concepts is brilliant. We always feel valued and respected as part of the study."
"[My baby] will be monitored more closely for markers of type 1 diabetes than if we were just relying on a doctor years down the line."
"[My baby] feels secure and not phased (at the moment) about being in a hospital environment, nor being held/pacified by nursing staff or doctors, which I believe to be a good thing if he were to ever visit hospital in the future."
PLEASE NOTE THAT THE SINT1A STUDY HAS NOW CLOSED TO RECRUITMENT
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