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What I had to do if I participated in the TRIGR
Study?
Participation in TRIGR is voluntary
Participation in the TRIGR study was voluntary. You
received information about the study from a local study
coordinator or physician and had an opportunity to
ask questions before agreeing to participate. Even if
you agreed to participate, we encouraged you to ask any
questions you might have about the study at any time.
How would I know if my baby qualified?
Mothers were 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) was taken at birth to test for the genetic
markers necessary for inclusion in the study. Approximately
45% of babies have the genetic markers of interest.
The remaining babies would 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 was expected of my baby and me if we participated?
A study coordinator spoke to you before you delivered
and explained the study. When you delivered your baby in
the hospital, you and your baby were identified as
TRIGR Study participants. Blood from the placenta (cord
blood) was collected after delivery. During the
first two years, there were 6 visits to the study centre
and the study dietitican will contacted you 3 times in
the first month and once a month after that until your
baby was nine months old. The study dietitian asked
a series of questions and provided 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 families who live a distance from the US site, the child's, 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.
In Canada, most study visits occur at the study centres. For those unable to visit a site, arrangements are made by the study coordinator for a more convenient location.
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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