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What is the POInT study?

Type 1 diabetes is an autoimmune disease. This means that the immune system, which primarily serves to defend the body against germs, attacks and destroys the insulin-producing cells (beta cells) in the islets of Langerhans in the pancreas. The aim of the Primary Oral Insulin Trial (POInT study) is to prevent the destruction of the insulin-producing cells of the pancreas in children with an increased risk of type 1 diabetes and therefore prevent the development of type 1 diabetes. The presence of beta-cell autoantibodies is an indication of the inflammation and destruction of the insulin-producing cells in the pancreas.

The POInT study aims to prevent these autoantibodies from developing by training the immune system so that this mistaken immune reaction does not occur. This is done with insulin powder, which is given daily together with a meal. The body’s own insulin is often the first target of the mistaken immune reaction, which leads to type 1 diabetes. Through exposure via the mucous membranes of the mouth and the digestive tract, the aim of the insulin powder is to train the immune system to tolerate the body’s own insulin, thereby preventing the destructive immune reaction. Unlike insulin that is injected, the insulin powder does not serve to lower the blood glucose level.

Why should my child participate in the POInT study?

In children with high-risk genes for type 1 diabetes, a mistaken reaction by the immune system that can start to attack the insulin-producing beta cells in the pancreas, is most likely to occur between six months and three years of age. This was shown in the results of the German BABYDIAB study and the international TEDDY study. This is why it is particularly advisable to take preventive steps to train the immune system in the first few years of life, before any symptoms of the destruction of the insulin-producing cells of the pancreas occur. In the best-case scenario, the development of type 1 diabetes can be avoided through this early training. If your child participates in the POInT study, they will be examined regularly. If your child does develop symptoms of the destruction of the insulin-producing cells, this can be identified at an early stage. There is no charge for the treatment and consultations carried out as part of the POInT study.

What indications are there that immune training works?

Initial promising results that training with insulin powder can succeed were found in a preliminary study known as the Pre-POINT study (JAMA 2015; 313(15):1-10. doi:10.1001/jama.2015.2928). Allergy research also provides further evidence that the concept of immune training can work in early childhood. In the published LEAP study, children who consumed peanuts up to the age of five developed a peanut allergy significantly less than the group that avoided peanut consumption (Du Toit G et al., N Engl J Med 2015).

How can my child participate?

To participate in the POInT study, your child must have at least a 10% risk of developing type 1 diabetes. The Freder1k study will identify whether your child is in this group. Children up to the age of four months can participate in the Freder1k study.

What happens in the POInT study?

Children aged between four and seven months can participate in the POInT study to prevent type 1 diabetes. At the beginning of the study, you and your child will be invited to regular examinations at intervals of two to four months until your child is one and a half years old. Your child will then be examined every 6 months until they are 3 years old. During this time, the study participants are given the contents of a capsule of powder each day. They take the powder together with food (e.g. stirred into baby food or yoghurt). Half of the participants are given insulin powder, and the other half are given a placebo (an inactive substance). It is a double-blind study, which means that neither the study participants nor the study staff know which capsules contain insulin and which contain the placebo. The treatment finishes when your child turns three years of age. Afterwards, further physical examinations and blood tests are carried out by our doctors at the study centre every six months. The longest possible period over which the follow-up visits will take place is until your child reaches seven and a half years of age.

Would you like to learn more about POInT and the study medication? Watch this video about taking the insulin powder


Oral administration of insulin in a type 1 diabetes intervention study

Helpful tips about giving insulin powder.

Who can participate in the POInT study?

Children can be included in the POInT study if …

  • … they are between four and seven months old.
  • … testing has shown that they have high-risk genes for type 1 diabetes.
  • … they have already begun to eat small quantities of baby food.

>> Take advantage of this opportunity: have your child tested for the risk of developing type 1 diabetes so that they can receive preventive treatment if needed.

Halftime: The world’s largest prevention study for type 1 diabetes in infants has reached an important milestone

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