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What do I have to do if I participate in the TRIGR
Study?
Participation in TRIGR is voluntary
Participation in the TRIGR study is voluntary. You will
receive information about the study from a local study
coordinator or physician and have an opportunity to
ask questions before agreeing to participate. Even if
you agree to participate, we encourage you to ask any
questions you might have about the study at any time.
How do I know if my baby would qualify?
Mothers are approached about the study while pregnant
if they have type 1 diabetes, the unborn child’s
father has type 1 diabetes or the unborn child has a
full sibling with type 1 diabetes. Blood from the placenta
(cord blood) is taken at birth to test for the genetic
markers necessary for inclusion in the study. Approximately
45% of babies will have the genetic markers of interest.
The remaining babies will not be eligible for inclusion.
Presence of the genetic markers does not mean that a
child will develop diabetes, but it does mean that there
is a slightly higher risk than if the markers were not
present. The reverse is also true. Children who do not
have the markers of interest may develop diabetes, but
their risk is less than those with the genetic markers.
What is expected of my baby and I if we participate?
A study coordinator will speak to you before you deliver
and explain the study. When you deliver your baby in
the hospital, you and your baby will be identified as
TRIGR Study participants. Blood from the placenta (cord
blood) will be collected after delivery. During the
first two years, there are 6 visits to the study centre
and the study dietitican will contact you 3 times in
the first month and once a month after that until your
baby is nine months old. The study dietitian will ask
a series of questions and provide you with advice if
needed. Annual visits to the centre are planned from
the age of 3 to 10 years. Study participation ends when
your child is 10 years old. In the US, the participant
is not expected to visit a site. For those infants eligible
to remain in the study, growth parameters, health information
and immunization record can be obtained by the study
nurse over the phone. Needed blood samples can be done
at a local hospital, doctor's office or lab. This will
be arranged by the study coordinator.
As previously stated, breastfeeding is considered the
best choice for your baby and local study teams will
support you in your choice. If you choose to supplement
or wean your baby prior to 8 months of age, you are
expected to use the assigned study formula. As well,
participating babies will not be allowed to have any
foods that contain cow’s milk. The study dietitican
will provide you with a written material and advice
to help you make proper food choices.
The information given here is a summary and we encourage
you to speak to local study coordinators and study doctors
for more information. Please see the list of Participating
North American Sites to find contact information for
the nearest participating city.
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