landmark Study Shows Oral Insulin Delays Type 1 Diabetes in High-Risk Children
MUNICH,GERMANY – November 16,2025 – In a groundbreaking advancement for type 1 diabetes prevention,the POInT study,a randomized,double-blind,placebo-controlled clinical trial,has demonstrated that oral insulin administration can significantly delay the onset of type 1 diabetes in children at increased genetic risk. the results, released today by researchers at helmholtz Munich, offer a potential new avenue for intervening in the autoimmune process that leads to the disease.
The POInT trial involved 143 children genetically predisposed to type 1 diabetes, who received either 7.5 micrograms of oral insulin daily (escalating to .5 mg within four months) or a placebo until the age of three. Researchers followed the participants until they reached six years and six months of age, meticulously tracking the development of islet autoimmunity – the early stage of type 1 diabetes.
The study, led by Prof.Anette-Gabriele Ziegler, Director of the Institute for Diabetes Research at Helmholtz Munich and Chair of Diabetes and Gestational Diabetes at the TUM Klinikum, and prof. Ezio Bonifacio, a member of the GPPAD study group and professor at the Centre for Regenerative Therapies at TU Dresden, represents the first of its kind to examine the impact of oral insulin on this vulnerable population.
“These findings are a major step forward in our efforts to prevent type 1 diabetes,” said Prof.Ziegler. “By intervening early with oral insulin, we can potentially delay or even prevent the disease from developing in children at high risk.”
The POInT trial is a key initiative of the Global Platform for the Prevention of Autoimmune Diabetes (GPPAD), a European platform dedicated to identifying at-risk children and conducting primary prevention studies. GPPAD is currently recruiting for its third clinical trial, AVAnT1A, focused on antiviral approaches to type 1 diabetes autoimmunity, following the POInT and SINT1A trials. GPPAD research centers are located across Europe, including Belgium, Germany, Sweden, Great Britain, and Austria.
The research was made possible through importent funding from the Leona M.and Harry B. Helmsley Charitable Trust, which has committed over $1 billion to type 1 diabetes research and care globally. Helmsley is the largest private funder of type 1 diabetes initiatives worldwide.
Helmholtz Munich, a leading biomedical research center with approximately 2,500 employees, focuses on developing solutions for a healthier society, with a particular emphasis on environmentally caused diseases like diabetes, obesity, and allergies. The center utilizes artificial intelligence and bioengineering to accelerate the translation of research findings into patient care.
Further Information:
* Helmholtz Munich: https://www.helmholtz-munich.de/
* Helmsley Charitable Trust: https://helmsleytrust.org
