The Pre-POINT study will take from
3
to 18 months.
There
will be two treatment groups:
One part of the children will be assigned to the active (insulin)
treatment group,
the others to the placebo (dummy) treament group.
The group to which each child is
assigned
is decided at random by a data-coordination center.
Neither your family doctor nor the researchers at the study
centers
will know or can influence the group to which your child is assigned.
This information can however be made available to the researchers or
other doctors looking after your child in case of emergency.
All
children will be treated with insulin or placebo during the whole
period that they are in the study.
The first day of the treatment takes place at the study center or at
your pediatrician or family doctor. Afterwards a parent or guardian
will be asked to give the study drug to the child at home.
The study drug is given as a small amount of tasteless powder while eating, e.g. in yoghurt or on bread, on a daily basis.
The study drug is given as a small amount of tasteless powder while eating, e.g. in yoghurt or on bread, on a daily basis.
While
your child is taking the
treatment we will monitor his/her blood glucose level regularly. On the
first day of the treatment we will measure the glucose level several
times in the study center or at your pediatrician or family doctor:
Before the first dose of the study drug is taken and after 30, 60 and
120 minutes. After that you will be asked to measure your
child’s
blood glucose at home. We will give you a blood glucose meter, test
strips and other equipment needed for this procedure. For the first
week you will be asked to check your child’s blood glucose
every
day, one hour after you have given the study drug. After the first
week, you will be asked to check his/her blood glucose once a month.
On the day of the blood glucose measurement we will call you and ask
for your child’s glucose results.
page up
page up
Visits to
the study center or to
your pediatrician or family doctor will take place at regular
intervals. At these examinations we will check on your
child’s
general health and, his/her growth and development. We will take blood
and saliva samples during the visits to the doctor to monitor the blood
glucose levels and the immune reaction. We examine these samples
regularly in order to check whether diabetes
antibodies are present. We
will write to you to keep you informed about the results of the
examinations.
page up
page up
At the
beginning of the study,
after 3 months, possibly after 9 months and at the end of the study we
will ask you to fill in questionnaires regarding the health of your
child and the personal stress that might come with the participation in
the study.
page up
page up
All
previous studies in which
patients with type 1 diabetes or people without diabetes persons aged
between 3 and 45 years have been treated with oral or nasal insulin,
have been safe.
Neither
oral nor nasal insulin in doses similar to those used in the
Pre-POINT study, has had any effect on the blood glucose.
However,
as a precaution, your child should always take the study medicine
during a meal.
We will call you between the appointments and ask you about your
child’s health. In addition, you can contact a physician of
the
Pre-POINT study at any time if there are any unexpected reactions.
page up
page up
The
treatment with oral
insulin used in the Pre-POINT study cannot be obtained by family
doctors or diabetologists and, at this point, there is no other study
that offers this kind of treatment.
The greatest advantage for your child is the possible delay or
prevention of developing type 1 diabetes. We cannot promise that the
participation in our treatment will lead to this kind of advantage.
However, as your child has a very high genetic diabetes risk,
examination of blood samples on a regular basis will help us to
recognize and to monitor diabetes autoantibodies early. Your child will
benefit from that fact even if he or she is treated with a placebo.
If your child actually develops type 1 diabetes, we will be able to detect the onset earlier, which is usually before your child shows the typical symptoms of type 1 diabetes. As a results of the early discovery and treatment of the type 1 diabetes the risk of becoming unwell at the onset of the disease and of long-term complications can be reduced. In addition, you and your child could have the opportunity to take part in other clinical studies of immune intervention that could potentially have influence the course of type 1 diabetes in a positive way. If your child develops diabetes, we would inform you about any suitable studies of this type.
page up
If your child actually develops type 1 diabetes, we will be able to detect the onset earlier, which is usually before your child shows the typical symptoms of type 1 diabetes. As a results of the early discovery and treatment of the type 1 diabetes the risk of becoming unwell at the onset of the disease and of long-term complications can be reduced. In addition, you and your child could have the opportunity to take part in other clinical studies of immune intervention that could potentially have influence the course of type 1 diabetes in a positive way. If your child develops diabetes, we would inform you about any suitable studies of this type.
page up
All
examinations within the scope of the diabetes Pre-POINT study are
free. Your child is covered by a health insurance.
page up
page up
Throughout
the whole study you can
contact our study teams of diabetologists and pediatricians personally
at any time if you have any questions and concerns. Just call our study
center.
page up
page up
You can
end your child’s
participation in the study at any time without giving reasons. If you
chose to do this, we would kindly request that you continue the visits
to the doctor so that blood samples can be taken. That way, we can
monitor the development of diabetes autoantibodies and the diabetes
risk of your child regularly.