Type 1 diabetes: New findings are reviving the debate about the inclusion of early detection tests in regular preventive care
31.01.2020 16:55
Scientists at the Helmholtz Zentrum München used the world's first early detection test for type 1 diabetes in a large, Bavaria-wide population study and examined the effects. With screening for islet autoantibodies, it is possible for the first time to diagnose presymptomatic stages of type 1 diabetes. A total of 90,632 children took part in the study. The results suggest that screening can prevent the progression of presymptomatic type 1 diabetes to dangerous diabetic ketoacidosis.
The study thus provides the basis for formulating new guidelines for future diagnostic procedures and for discussing a recommendation regarding the inclusion of screenings in the catalog of standard preventative care services.
Type 1 diabetes is the most common metabolic disease in children and adolescents, sometimes with life-threatening consequences. “We are working on a world without type 1 diabetes,” says Prof. Anette-Gabriele Ziegler, director of the Institute for Diabetes Research at the Helmholtz Zentrum München. The scientist and doctor wants to counteract the disease in the presymptomatic stage with immunomodulating agents. “In order for us to treat type 1 diabetes early, we need to detect the disease as early as possible. To do this, we need appropriate diagnostics in childhood,” explains Ziegler.
Collaboration with pediatric practices
Together with her research group, Ziegler launched “Fr1da”: In the study, the team tested 90,632 children between the ages of two and five across Bavaria from 2015 to 2019 for the presence of islet autoantibodies. 682 pediatricians in Bavaria took part in the implementation of the screening study by including the Fr1da blood test in their routine early detection examinations as a voluntary additional service for families.
Diagnosis via islet autoantibodies
Presymptomatic type 1 diabetes can be diagnosed by detecting at least two islet autoantibodies in the blood. The presence of these antibodies indicates that the body's immune system is attacking the insulin-producing beta cells of the pancreas - the cause of type 1 diabetes. These antibodies can be detected in the blood years before the first symptoms of the disease appear. Using a novel approach, the research group classified the children who had antibodies in their blood into three stages: stage 1 (normoglycemia), stage 2 (dysglycemia) or stage 3 (clinical type 1 diabetes). This classification enables individual follow-up and treatment of the children.
Prevent diabetic ketoacidosis
The examination of 90,632 children revealed presymptomatic type 1 diabetes in 280 children (0.31 percent). Of these 280 children, 24.9 percent developed clinical type 1 diabetes (stage 3). Only two of them developed diabetic ketoacidosis. Ziegler comments on the results: “A potential clinical benefit of early detection of presymptomatic type 1 diabetes is a reduction in dangerous diabetic ketoacidosis.” In this study, the prevalence was less than 5 percent. In Germany, more than 20 percent of children who have not been tested currently suffer from diabetic ketoacidosis; in the USA it is 40 percent. This suggests that screening can reduce the severity of the disease progression not only in Germany but worldwide.
Bavaria's Health Minister Melanie Huml emphasizes: “The Fr1da study, funded by the Bavarian Ministry of Health, is an important contribution to the early detection of type 1 diabetes mellitus. The high number of children tested and the participating pediatricians in Bavaria is a great success. My hope is that the results will help to provide the best possible support and support for affected children and their parents. Timely treatment makes it possible to prevent the later development of serious complications from diabetes mellitus, such as cardiovascular diseases or kidney damage. My goal is also to make parents more aware of diabetes in children. Across Bavaria, around 4,500 children, adolescents and young adults under the age of 20 are affected by type 1 diabetes, which is currently not curable. This disease requires further intensive research. That’s why I was happy to take on the patronage of the Fr1da study.”
New guidelines for standard care
“In today's rapidly changing world, the Helmholtz Zentrum München stands for cutting-edge research that provides innovative solutions for a healthier society. This study is a perfect example of how, with this strategy, many years of hard work by our scientists can directly benefit patients worldwide,” explains Prof. Matthias Tschöp, CEO of the Helmholtz Zentrum München.
In a next step, the researchers will carry out a cost-benefit analysis of the screening. It could further support the inclusion of screening for presymptomatic type 1 diabetes in standard care and the catalog of services provided by statutory health insurance companies. “Early diagnosis would make our path to a world without type 1 diabetes much easier,” says Ziegler. Together with an international team, she is working intensively on the development of an effective prevention therapy to prevent the onset of type 1 diabetes. Early diagnosis is an important prerequisite for this major goal.
The Fr1da study is carried out by the Helmholtz Zentrum München, the Bavarian Pediatric Association (BVKJ e. V.) and PaedNetz Bayern e. V. carried out. It is under the patronage of the Bavarian Health Minister Melanie Huml and is receiving great international attention. It was supported by the JDRF, the LifeScience Foundation, the Leona M. and Harry B. Helmsley Charitable Trust, the Bavarian State Ministry for Health and Care, the German Diabetes Foundation, the BKK Bavarian State Association, the B. Braun Foundation, the German Diabetes Aid and the German Center for Diabetes Research (DZD). The screenings have now been expanded to the state of Lower Saxony (Fr1dolin study) and have become a model for numerous other initiatives worldwide.
Original publication
A. Ziegler et al, 2019: Yield of a public health screening of children for islet autoantibodies in Bavaria, Germany. JAMA, DOI: 10.1001/jama.2019.21565