About the Study
The ELSA Study is recruiting 20,000 children in the UK to explore the feasibility and benefits of screening for type 1 diabetes.
What does the ELSA Study involve?
In the ELSA Study, we are screening children for type 1 diabetes. The study has 5 steps:
- Step 1 – Finger prick blood test to screen for antibodies (20,000 children)
- Step 2 – Venous blood test to test for antibodies (for children who screened positive at stage 1)
- Step 3 – Venous blood tests for staging of type 1 diabetes (for children who tested positive at stage 2)
- Step 4 – Education session (for parents of children at-risk)
- Step 5 – Interviews with parents/guardians to provide feedback on the screening programme
What are we testing for?
In the ELSA study, we are testing for antibodies (protein markers in the blood) because antibodies are markers of risk of type 1 diabetes. There are 4 antibodies we are testing for in the ELSA Study.
As the number of antibodies a child has rises, this increases their risk of developing type 1 diabetes in the future. For example, for children who have 2 of these antibodies, within the next 10 years, 3 in 4 of these children will develop symptoms of type 1 diabetes.
For children who have 1 of these antibodies present, their risk is not as high, but they could develop more antibodies over time.
For children who do not have any of these antibodies, this means they are currently at low risk of developing type 1 diabetes. But, they could still develop antibodies in the future
3 in 1000 children are at high risk of getting type 1 diabetes and we can only find these children by screening.
Click on the stages below to find out more
This involves a finger-prick blood test, where a few drops of blood are placed onto a card. This can be done at home, at school, at the GP, or in the community. Currently, home testing is available for families living in England, Scotland and Wales. Community sites will be opening across the UK from January 2023 onwards. The parent/guardian can do the test for the child or one of our friendly study team can do this for you. The finger prick will cause only mild discomfort for a second.
This blood spot card will go to our laboratory and will be tested for antibodies. If it comes back negative, this means we cannot find antibodies in the blood spots, so your child is currently at low risk of developing type 1 diabetes in the future. However, the risk is never 0%, because antibodies could still develop over time. Fortunately, for 99/100 children tested in our study, their test will come back negative, and they will not require any further follow-up in the ELSA study. You will receive a text message and an email or letter with your child’s result. We will also let your child’s GP know the result, because it may be helpful for your child’s healthcare team in the future.
If the blood spot card comes back positive, this means antibodies are present in the blood sample, and we need to do another confirmatory blood test to investigate further. This blood test is more accurate than the initial screening test and helps us to understand which antibodies your child is positive for. We will inform the parent/guardian by phone and book your child in for a venous blood test. This will be done at a hospital as near to you as possible. We can cover your travel costs if you can provide us with your receipts. The venous blood test is a bit more uncomfortable than the finger-prick test, but we can use a cream to take away the pain.
The venous blood sample will also be sent to our laboratory for testing. In some cases, the venous blood test may come back negative, even though the first test was positive. We understand this sounds confusing. This is because the venous test is more accurate and is testing for 4 different antibodies. If the result is negative, we will phone the parent/guardian and send an email or letter with the result. The good news is your child is currently at low risk of developing type 1 diabetes in the future and does not need any further follow-up in the ELSA study. However, the risk is never 0%, because antibodies could still develop over time. We will therefore let your child’s GP know the result, because it may be helpful for your child’s healthcare team in the future.
If this blood test comes back as positive, we will identify which antibodies your child is positive for.
If your child is positive for 1 of the 4 antibodies tested, this means your child is at some risk of developing type 1 diabetes, in the future. However, we do not need to do any more blood tests at this stage. We will call the parent/guardian to explain the result and what this means, and we will invite you to an education session. This will teach you and your family about the signs and symptoms of type 1 diabetes and answer any questions you have. Your child can also join a programme for monitoring and follow-up. This may involve a blood test every couple of years to check for antibodies over time. The monitoring follow-up is optional but is strongly encouraged by the study team.
If your child is positive for two, three or four of the four tested antibodies, this means your child is at high risk of developing type 1 diabetes in the future. We understand this may be difficult news for the family, but the ELSA study team will support you and explain what the next steps are. Your child will need to have another (final) blood test, because we need to know how close to getting type 1 diabetes your child is, and if insulin needs to be started straight away.
This blood test will be done at a hospital as near to you as possible. We can cover your travel costs if you can provide us with your receipts. We can also offer overnight accommodation if the hospital is too far away from your home.
This venous blood test is a bit more uncomfortable, but we can use a cream to take away the pain. Your child will need to fast overnight and will have the blood test in the morning before eating. Then, we will give your child a sugary drink and we will take some more blood samples after this.
We will give you a call to let you know the results. For some children, this blood test may show that the pancreas is already not working properly (see ‘what is type 1 diabetes’), so your child may need to be referred to the paediatric diabetes team to be started on insulin. For most children, they will not be at this stage but will be at high risk of progressing to type 1 diabetes over time. We will phone the parent/guardian to let them know about this result and explain what this means. We will then arrange an education session for the parent/guardians.
We will arrange an education session for you at a convenient time. The education session will be a video call with the ELSA Study team. We could also arrange a face to face meeting if video call is not possible. In the education session, we will explain what the screening results mean and what this means for your child’s future. We will explain what type 1 diabetes is and what the signs and symptoms of type 1 diabetes are. We will also outline the next steps after ELSA. For example, your child may be eligible for the INNODIA monitoring follow-up programme (https://www.innodia.eu/). This may involve a blood test every 6 months to check for antibodies and glucose levels over time. The monitoring follow-up is optional but is strongly encouraged by the study team. Families of children at high risk will also be informed about research studies testing new treatments to delay the start of type 1 diabetes.
Before and after the education session, we will ask the parent/guardian to fill-in a study questionnaire to tell us about your thoughts, feelings and any concerns.
After the screening programme is complete, we will invite parents/guardians to an interview to gather your feedback on the screening process. We want to know anything that was good or bad about the screening programme. It is your choice if you would like to take part in the interview. We understand the interview may be distressing, but the study team will support you and you can stop the interview at any time.
Why are we doing the ELSA Study?
3 in 1000 children are at high risk of developing type 1 diabetes in the future. The only way we can find these children is through screening.
Screening allows us to pick up type 1 diabetes sooner. This stops children from becoming too unwell and prevents children from needing to go into hospital as an emergency admission for type 1 diabetes. Children at high risk can also be followed up closely to monitor antibodies (protein markers) and glucose over time to see when treatment for type 1 diabetes needs to be started. Children found to be at high risk could also enter research trials, testing new treatments which aim to delay or prevent the start of type 1 diabetes.
ELSA Interventions: Education and further research
ELSA – Education
All families will be invited to an education session if their child is found to be at risk of developing type 1 diabetes in the future. This is really important so that we can inform the family about the signs and symptoms of type 1 diabetes and to explain what their child’s screening results means. The ELSA Study team will contact you to arrange this.
ELSA – Further research
Children found to be at risk of type 1 diabetes, will be invited to join the INNODIA monitoring follow-up programme. The ELSA Study team will provide you with more information about this during the education session. You can find out more about the INNODIA monitoring here: https://www.innodia.eu/.
There is an international drive to screen children for type 1 diabetes as there are a growing number of research studies testing new treatments which could delay the start of type 1 diabetes. In the education session, we will tell you about research studies your child may be eligible for. More information about research trials into type 1 diabetes can be found here: https://type1diabetesresearch.org.uk/
What is type 1 diabetes?
Type 1 diabetes is an autoimmune condition. This means the body’s own immune system attacks the pancreas, an organ in the body which produces insulin. Insulin is a natural hormone needed for everyday life. Insulin is like the key needed to unlock nutrition from our food.
Type 1 diabetes is different from type 2 diabetes. Type 2 diabetes is caused by genetic and lifestyle factors, whereas type 1 diabetes is caused by genetic and environmental factors.
Children with type 1 diabetes cannot make their own insulin so they become very unwell. The signs and symptoms of type 1 diabetes include increased frequency of passing urine, increased thirst, weight loss, and tiredness. If you child has these symptoms, we would advise you to contact your General Practitioner (GP) or seek medical attention urgently by calling 111 or 999 in the UK.
Some children who are newly diagnosed with type 1 diabetes become extremely unwell. They may develop a condition called diabetic ketoacidosis. This is when the sugar level is very high because there is not enough insulin. Children with diabetic ketoacidosis need to go into hospital for treatment.
Children with type 1 diabetes need to take replacement insulin and continue this for the rest of their lives. You can find out more about what type 1 diabetes is and what it is like to live with type 1 diabetes on the Diabetes UK website: https://www.diabetes.org.uk/diabetes-the-basics/types-of-diabetes/type-1 and the Juvenile Diabetes Research Foundation (JDRF) website: https://jdrf.org.uk/information-support/about-type-1-diabetes/.
The ELSA 1 Study
In the ELSA 1 study, we are holding interviews and focus groups with families, parents, children and stakeholders to understand their thoughts on screening children for type 1 diabetes. This has helped us to design the ELSA Study screening programme. Thank you to all of the families and stakeholders who took part in these interviews. If you would like to find out more about the ELSA 1 study, please visit the study site here:
ELSA organisation logos
A special thank you to all of the parents, carers and young people who have contributed to the design and delivery of the ELSA Study.