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New study of babies in Skåne to prevent type 1 diabetes

Can insulin absorbed in small doses through food in early childhood get the immune system accustomed to insulin and thereby delay – or prevent – type 1 diabetes?
Researchers hope to find the answer through POInT, a study starting in Skåne this autumn.

Astr1d är en screeningstudie för att hitta barn med hög risk för typ 1-diabetes.

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.

Facts about POInT

POInT is an investigator-driven randomized controlled trial, sponsored by the Technical University Munich /Helmholtz Center Munich, Germany, and funded by the American foundation, The Leona M. and Harry B. Helmsley Charitable Trust.


Facts about the screening (Astr1d)

Astr1d is a screening study covering newborns in Sweden. The screening aims to identify children with an increased risk of autoimmune diabetes (type 1 diabetes). The screening sample is taken from the blood in the umbilical cord, making the process both risk-free and painless. In total, researchers expect to screen around 50 000 children in Skåne. The samples can also be kept as a resource for future research. The screening is funded by the American foundation, The Leona M. and Harry B. Helmsley Charitable Trust.

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Lund University Diabetes Centre, CRC, SUS Malmö, Jan Waldenströms gata 35, House 91:12. SE-214 28 Malmö. Telephone: +46 40 39 10 00