A groundbreaking clinical trial, known as POInT, has shown promising results in preventing early onset of type 1 diabetes in children with genetic susceptibility through daily oral insulin intake. The trial aimed to prevent or delay the appearance of islet autoantibodies, an early indicator of the disease’s development.
Led by a team from the Helmholtz Munich and the Technical University of Munich (TUM), in collaboration with the Global Platform for the Prevention of Autoimmune Diabetes (GPPAD), the trial began in 2017 across five European countries and included 1,050 children. The study represents the culmination of over three decades of genetic and immunological research aimed at early prevention.
Preventing Type 1 Diabetes with Oral Insulin
The researchers found that oral insulin intake was safe and well-tolerated among the children, but it did not affect the overall development of autoantibodies, making the primary outcome of the trial “neutral” or “negative.” However, exploratory analyses revealed encouraging signs, including a delay in the clinical onset of diabetes among children who received oral insulin compared to the control group.
Additionally, the study found that the treatment’s effect was associated with variations in the insulin gene among the children. According to Ezio Bonifacio, a member of GPPAD and professor at the Technical University of Dresden, more than half of the participants carried genetic variants that increased their risk of developing type 1 diabetes. Oral insulin provided protection for this group, while it led to an increase in autoantibodies among children with lower-risk variants.
Personalized Prevention Based on Genetics
Professor Anette-Gabriele Ziegler, the study’s principal investigator, stated that despite not achieving the primary endpoint, the results “hint at a positive effect on the disease’s course.” She emphasized that the variation in response based on genetics paves the way for developing personalized preventive interventions.
The researchers will continue to follow the children until they reach the age of 12 to assess the long-term impact of the treatment. They will also analyze the collected samples and data to deepen their understanding of the early stages of the disease.
Future Directions
The study’s findings indicate a potential path toward genetically guided prevention, opening the door to a new era in combating type 1 diabetes before its onset. The next steps will involve further analysis and potentially new trials to confirm the efficacy of personalized prevention strategies.
As the research continues, uncertainties remain regarding the long-term effects of oral insulin intake and its potential benefits for different genetic profiles. The scientific community will be watching closely for the outcomes of ongoing and future studies to determine the best course of action for preventing type 1 diabetes.
