Type 1 diabetes affects 1 in every 250 children born in the UK every year.   

By screening newborns, the INGR1D2 study can identify which babies are at higher risk of developing type 1 diabetes. This offers parents the chance to learn more about the early signs and symptoms of type 1 diabetes and the chance to get involved in further research aimed at reducing the chance of their baby developing the condition.

Type 1 diabetes is what is known as an 'auto immune' disease.  Normally our immune system works to protect us from disease.  In type 1 diabetes the body's immune system responds wrongly to the insulin producing cells (called "beta cells") in the pancreas and destroys them.  This affects the production of insulin, the hormone that keeps levels of glucose in the blood table. This then leads to the onset of type 1 diabetes.  

Type 1 diabetes affects 1 in every 250 children born in the UK every year.  It is a lifelong condition that causes glucose levels in the blood to become too high.  People with type 1 diabetes have to take insulin every day to manage their condition which can be very disruptive and difficult, especially for children and young people.  Having type 1 diabetes also increases the risks of a person developing other medical conditions.  

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.  Learn more about Type 1 diabetes .  

Research has shown us that some people have a combination of genes that make it more likely that they will develop type 1 diabetes (genes are tiny instructions inside our bodies that help determine how we grow, develop, and function).  When people have this combination of genes, it does not mean that they have type 1 diabetes, just that it is more likely they will develop the condition compared with people who don't have these genes.   

Research also shows that factors in our environment can trigger the onset of type 1 diabetes in those with higher risk genes.  These factors include viruses, including the Covid-19 virus .  This virus is very common - around half of babies have had covid-19 by the time they are 1 year old.  Learn more information about Type 1 Diabetes and genetic risk.  More in-depth scientific information can be found in this research paper.

The INGR1D2 study uses blood spots collected by the NHS as part of the newborn blood spot test  (the 'heel prick' test) taken a few days after birth.  This means no additional blood sample needs to be taken and the test is free of charge.  This blood is used to see if a baby has the genes that make it more likely that they will develop type 1 diabetes.  This gives us the chance to offer parents of these babies the choice to take part in another study (called The AVANT1A study).  The AVAnT1A study is looking at whether vaccination against covid-19 can prevent or delay the onset of type 1 diabetes.   As with the INGR1D2 study, the AVAnT1A study is optional.

There are criteria that must be met before a baby can take part in INGR1D2:   

• You can choose to take part once your pregnancy is over 18 weeks gestation, and up until your baby 5 days old

• You must be planning for your baby/babies to have the ‘newborn blood spot test’ when they are five days old in one of the participating regions

• You must be having your baby at one of the hospitals participating in the INGR1D2 study (see here for information about hospitals taking part in this study) 

• You must know whether either (biological) parent has diabetes and the type of diabetes (type 1 or type 2)

• You have to be able to understand the written and verbal English language

If you are unsure if you are eligible to take part and would like to speak to a member of the INGR1D2 research team, then click here  to find contact details for your area.  

If you choose to take part in the INGR1D2 study you will be asked to read the participant information sheet and sign a consent form or give your consent verbally.  We will collect a small amount of information about you that is helpful for the research.  After this you do not need to do anything.  

When your baby is 5 days old, they will have the 'heel prick' test as part of their NHS care (see below for more information about this).  We will arrange to take a small amount of the blood that is already collected during the heel prick test in order to look at your baby's genes. We will receive the results from this when your baby is around 2-3 months old and let you know about them by phone (if your baby has a higher risk result)  or by text (if your baby has a lower risk result).

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. 

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.

We are researching ways to prevent the things that can trigger type 1 diabetes in those at risk, long before symptoms develop and insulin treatment is needed.  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.  It does not require additional blood tests and there is no financial cost to parents who take part in INGR1D2.   Babies who are identified as being higher risk have choices about taking part in further research which are only available to those who have taken part in the INGR1D2 study.

If the INGR1D2 study finds that your baby does not have a higher risk of developing Type 1 Diabetes you will receive a text notifying you of this result. This text will include a link to more information about the meaning of a lower risk result.  

If your child is found to have 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.  They will then contact you by telephone within 3 months of the test to explain the result and answer any questions you have.  We will ask your permission to let your GP know about this result.

It is important to know that babies given a higher risk result have a higher chance of developing type 1 diabetes, but it does not mean they will definitely develop the condition - in fact, most children with high-risk genes will never go on to develop diabetes. We will give you detailed information about the symptoms of diabetes and what to do if your child does develop these symptoms.  After this call we will also provide you with a written booklet with further information. We will also ask if we can let your GP know this result.   

Babies who receive a higher risk result also have the chance to take part in a research study called AVAnT1A (Anti-viral action against Type 1 diabetes autoimmunity).   AVAnT1A is looking at whether vaccination against CoViD-19 at the age of 6 months can prevent children at increased risk of type 1 diabetes from beginning to develop the condition. Babies taking part in the AVAnT1A study receive extra monitoring so that, if type 1 diabetes begins to develop, it can be identified and treatment started as early as possible.  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.

INGR1D2 and AVAnT1A are two different studies.  Agreeing to take part in INGR1D2, and receiving a higher risk result, does not mean that your baby has to take part in AVAnT1A - it is always your choice. If you are invited to take part in the AVAnT1A study, you will be given information and time to decide whether you would want to take part.  If you then decided not to take part in AVAnT1A,  you would not have to give a reason why.  If you chose to take part in AVAnT1A, you would be asked to sign a separate consent form.  Find out more about the differences between the INGR1D2 and AVAnT1A studies and how they work together.

You may be asked about the INGR1D2 study during your pregnancy or on the postnatal ward if you are booked at a participating hospital.  You might also receive a phone call from one of our research teams.  The INGR1D2 teams are  currently approaching pregnant women and new parents at participating hospitals/regions from Monday to Friday. If you are approached by one of our researchers, over the phone or face to face, you will be given all the information you need to make a decision on whether to enrol your baby.  A member of our research team will answer all of your questions before you decide if you would like to take part.

 If you would like to let us know that you are interested in taking part, or if you would like more information, you can contact a member of our research team at your hospital.  They will be very happy to talk to you and answer your questions.   All the contact details for hospitals taking part in the INGR1D2 study can be found here.   

The results of the INGR1D2 study usually take 2-3 months to be received and communicated to parents who are taking part.  They are communicated using the contact details given to the research team udring consent.  If more than 3 months have passed and you have not received a result, or if your contact details have changed, then you should contact your local INGR1D2 research team who will be happy to help.