What type of research study is ENDIA?
ENDIA is a non-interventional observational study. There are no “case” or “control” groups. All participants will undergo the same procedures and questionnaires.
What is the aim of the study?
The aim of the ENDIA study is to identify the environmental factors that may influence the development of Type 1 Diabetes. We will look at the interactions between these environmental factors and their relationships with genes.
Will I have to take any medications or change my lifestyle if I participate in the study?
No. ENDIA is a non-interventional study. Neither you nor your child will receive any treatments or therapies that you would otherwise not have access to without participating in the project. You should continue taking regular medications and follow the advice of health professionals. There are no restrictions on your or your child’s activities while participating in this study. We just want to learn about the factors in the environment that may influence or protect against Type 1 Diabetes.
Who can participate in ENDIA?
We are asking women who are pregnant and have Type 1 Diabetes themselves or have a family member with Type 1 Diabetes who would be a first-degree relative of the baby, i.e. the baby’s father or the baby’s older sibling, to consider participating.
Babies less than 6 months old with a mum, dad or sibling with Type 1 Diabetes are also eligible.
How many people will participate in the study?
We will be following 1400 children Australia-wide with recruitment taking place in SA, Victoria, NSW, Queensland and WA. Most of the children will be recruited before they are born, although babies less than 6 months old with a first-degree relative with Type 1 Diabetes are eligible to join the study. Because recruitment occurs in pregnancy, we will taking samples from the pregnant mother to learn about the environment her baby is developing in.
Which hospitals are participating in ENDIA?
In NSW: The Children’s Hospital at Westmead, The Sydney Children’s Hospital, The Royal Hospital for Women, St Georges Hospital
In Queensland: The Mater Women’s Hospital, The Mater Children’s Hospital, The Wesley Hospital
In SA: The Women’s and Children’s Hospital
In Victoria: The Royal Melbourne Hospital, The Royal Women’s Hospital, The Geelong Hospital
In WA: The Princess Margaret Hospital
Do I have to deliver my baby at one to these hospitals to participate in ENDIA?
No, but you will be recruited through and followed by one of the hospitals listed above. This means that your study visits are likely to take place at the participating hospitals. We will work with the hospital you are expecting to deliver you baby at to ensure your involvement in ENDIA runs smoothly and has the required institutional approvals. Please contact us using the Contact form or email firstname.lastname@example.org directly and we can work out a suitable arrangement.
What if I live in regional Australia – can I still participate?
Yes. The Regional Participation Program enables eligible families who cannot access our participating hospitals to take part in the study. Participants will collect and ship their samples from their own home or with the assistance of a medical professional such as a local GP or endocrinologist. The data and samples provided by regional participants are valuable and will contribute to finding out what causes type 1 diabetes. Please contact us using the Contact form or email email@example.com directly and we can formulate a suitable arrangement.
What are the possible benefits of being involved in ENDIA?
There will be no immediate benefit to you from your child participating in this research. However, we will be collecting a lot of information about possible things in the environment that may be relevant to your child’s risk of developing Type 1 Diabetes.
If during the study your child develops islet autoantibodies, which would increase his/her risk of Type 1 Diabetes, you will be counselled about this. You will meet with your local Investigator to discuss the implications. Your child may be invited to participate in prevention trials that are being conducted in Australia. You will also be informed:
- If your child has antibodies that denotes Coeliac Disease and, if necessary, a referral will be made to a paediatrician who specialises in Coeliac Disease
- Of your Vitamin D levels during pregnancy
- Of your child’s Vitamin D levels
- Of your child’s weight and length/height at each visit
What are the possible risks of being involved in ENDIA?
The risks associated with participating in this study are low. Having blood taken can cause some discomfort, but we will offer a numbing cream to reduce discomfort. Occasionally, there may be some bruising at the venipuncture site. The amount of blood taken in infants will be less than the maximum allowable based on the American National Institutes of Health (NIH) recommendations (< 3.0 mL/kg at any single visit). The study will involve genetic analysis of both the participating child and the family member with Type 1 Diabetes. The results of this analysis may affect other family members and could provide increased anxiety within the family. For example, if we find out that you, your partner, or your children carry high risk genes then it is possible that other family members not participating in the study also have these genes. Families may be faced with the decision to reveal, or not to reveal, this information. It is important to understand that results from genetic research alone will not confirm the presence of Type 1 Diabetes – just an increased risk for development of type 1 diabetes in the future.
Why does my baby have to have blood tests?
In order to determine whether your child has developed islet autoantibodies we will need to collect a relatively small amount of blood. We will also be doing other tests on the blood that are relevant to the study, including vitamin D levels and antibodies that are indicative of Coeliac Disease. The amount of blood required ranges between 1 and 3 teaspoons (5-15 mL) and is very safe for your child. We will offer a numbing cream to reduce the discomfort that may be associated with venipuncture.
How long is the ENDIA study?
This is a prospective study from pregnancy into the first 3 years of life. However, we hope to continue following our ENDIA children in the future. If this study continues beyond 3 years participants will be asked to sign an additional consent form at that time. If you wish to participate in ENDIA you are not obligated to continue participating beyond 3 years.
Will I be paid to participate?
No. Neither you nor your family will be paid for participation in the study.
Will it cost me anything?
No. There is no charge to you for consultations, sample collections and blood tests related to the trial.
Can I leave the study at any time?
Yes. If you wish to stop participating in ENDIA for any reason at all you can do so at any time. You are under no obligation to finish the sturdy, but we hope that you will. If you decide not to continue, you decision will not affect your future medical care, you child’s future medical care or your relationship with the participating hospital in any way.
Who is funding ENDIA?
Funding for this study is provided by the National Health and Medical Research Council (NHMRC) of Australia and the Juvenile Diabetes Research Foundation (JDRF).
Will participation in this study affect my or my child’s ability to get life/health insurance now or in the future?
We will be collecting DNA from your child for the measurement of risk genes and this may have implications for their future. We will also determine whether your child has islet autoantibodies, which increases their risk of developing Type 1 Diabetes. A person has a duty under both the common law and statute (in Australia, the Insurance Contracts Act 1984) to disclose to an insurer every matter that he/she knows could be relevant to the decision of the insurer whether to accept the risk. If an insurer asks a direct question about the results of tests that your child has had, then the person (either yourself on the child once they are older) has an obligation to answer the question truthfully. Failure to answer truthfully could result in, amongst other things, the policy being voided by the insurer.
What about my and my child’s privacy?
Participants in ENDIA will be identified by name and a study number by the researchers in the study. However, when the results of the study are analysed by the statistician only the study number will be used. When the results of the study are published there will be no identifying information. You and your child’s information will remain confidential except in the case of a legal requirement to pass on personal information to authorised third parties. This requirement is standard and applies to information collected both in research and non-research situations. Such requests to access information are rare; however we have an obligation to inform you of this possibility.
When will the outcomes of the trial be available?
The ENDIA study has been designed based on the prediction that a certain number of children will develop islet autoantibodies. This will take several years to occur and results will not be available until we have clear groups of antibody-positive and -negative children. When this time comes the data will be analysed by statisticians and published in the scientific medical literature.
Will this trial contribute to finding a cure for Type 1 Diabetes?
Yes, because there will be no cure without identifying what triggers the autoimmune process behind Type 1 Diabetes. A cure for Type 1 Diabetes will involve replacing or regenerating lost insulin-producing beta cells. Insulin itself and other components of the beta cells are targets of the destructive autoimmune response. The immune system has a memory so as soon as insulin-producing cells are replaced or regenerated they will again be attacked by the same autoimmune process that destroyed them in the first place. Repeated exposes to the triggers of islet autoimmunity may accelerate the process. Therefore, approaches to preventing Type 1 Diabetes will also be critical for attempts to cure Type 1 Diabetes by replacing or regenerating insulin-producing cells.