Newborn babies in Skåne with a high risk of autoimmune diabetes (type 1 diabetes) can take part in the study. The infants from Skåne, together with children in Germany, the UK, Poland and Belgium, are part of a major initiative to prevent autoimmune diabetes (type 1 diabetes). Children who are shown through screening to have a high risk of developing the disease, because they carry particular genes, have a ten per cent risk of developing multiple autoantibodies (see fact box) before the age of six, compared with just over half a percentage point in the rest of the population. In Sweden, the screening started in the summer and will continue for five years.

The study is entitled POInT (Primary Oral Insulin Trial). It aims to investigate whether it is possible to accustom the immune system to insulin by administering insulin to the child through food, rather like immunosensitisation for allergies, which involves exposing the patient to small doses of the substance to which they are allergic. In previous studies, oral insulin has proven to be very safe.

“No side-effects have been observed. The insulin is to affect the immune system cells in the oral cavity, e.g. in the tonsils. In this way, we hope to be able to prevent the child developing an autoimmune reaction to its own insulin”, says paediatrician and associate professor Helena Elding Larsson, who is responsible for the study in Skåne.

Structure of the study

Half of the children in the study will be given insulin orally, while the other half will receive a placebo. The children will receive a daily dose starting at four to seven months and until they reach the age of three years. The insulin (or placebo) comes in small capsules that are opened and mixed into food. The capsules contain an odourless, tasteless powder that is absorbed in small tasting portions. The dose administered has been tested and, in previous studies, has not shown any effect on blood glucose levels (blood sugar).

The participants in the study will be monitored through regular check-ups including blood samples taken from the children.

Facts / About autoimmune type 1 diabetes

Autoimmune diabetes (type 1 diabetes) is among autoimmune diseases in which the immune system attacks the body’s own cells. In the case of autoimmune diabetes (type 1 diabetes), the insulin-producing beta cells in the pancreas are destroyed. Sufferers must therefore administer insulin to themselves for the rest of their lives. One sign that the attack on the beta cells has begun is the presence of one or several (multiple) autoantibodies against the protein in the beta cells. The child may then develop diabetes within one to two years, but it may also take longer.