The ENDIA Study
Who are we asking to be in the study?
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.
Throughout Australia, we will follow 1400 women in their pregnancies and the babies born from those pregnancies. The initial period of the study is three years; however, we hope to continue following the children into adolescence.
What will our ENDIA families have to do?
Depending on when your family enters the study, we will meet with you during the 1st, 2nd and 3rd trimesters of pregnancy, just after the baby is born, and on a further 10 occasions when your baby is 3, 6, 9, 13, 15, 18, 21, 24, 30 and 36 months of age.
At the study visits we would like to take several harmless swabs from various sites of the body and blood samples from the mother during pregnancy and the baby once born. The amount of blood taken is very safe for pregnant women and babies. We need to take blood from your baby to measure whether he/she has developed islet autoantibodies.
There will also be questionnaires to complete and we would like you to provide urine, stool and breast milk samples that can be collected in the privacy of your own home.
We would also like to take a DNA sample from the family member with Type 1 Diabetes, in order to understand how genes might affect the baby’s predisposition to Type 1 Diabetes.
If you live in a regional area, you might be eligible to participate in ENDIA's Regional Participation Program. The Regional Participant Program has been designed to incorporate as much of the ENDIA study that can be safely and effectively performed by participants in their own homes or with the assistance of a health professional such as a local GP or endocrinologist.
What will the ENDIA investigators be looking at?
The ENDIA team will be investigating a number of environmental factors that we believe may contribute to the development of islet autoimmunity and Type 1 Diabetes in children. These factors include:
- The genes of the participating child and their family member with Type 1 Diabetes
- The community of the bacteria that naturally lives in a mother’s body during pregnancy and the child’s body during early life
- The amount of weight gain during pregnancy and early life
- The method of delivery (natural birth versus caesarean section)
- The mother’s nutrition during pregnancy and breast feeding
- The duration of breast feeding and the child’s nutrition during early life
- The child’s immune system and when the child received vaccines
- Exposure to viruses during pregnancy and early life
Who has approved the study?
ENDIA has been reviewed and approved by the Human Research Ethics Committees (HRECs) representing the various sites that are participating in ENDIA. HRECs protect the interests of people who agree to participate in human research studies.