Incidence of T1D is increasing in children and adolescents, yet the causes of the autoimmune disease and methods to effectively prevent it are still unknown. In Bavaria, Germany, an innovative study is taking a major first step for type 1 diabetes (T1D) prevention – that is, identifying individuals who might benefit from preventative therapies.

The Fr1da study, led by Helmholtz Zentrum München, the German Research Center for Environmental Health, is a population-wide screening initiative that aims to screen young children ages 2-5 to detect T1D-related autoantibodies—which signal an early stage of the disease’s development. Relatives of people with T1D have previously taken advantage of this type of testing, but this approach has seldom been done in the general population.

Helmholtz Zentrum München began routinely screening in 2015, and has since screened over 70,000 Bavarian children. If early stages of the disease are detected, families are offered comprehensive educational and psychological support to reduce stress and provide positivity.

We are so glad that our daughter Julia’s T1D was recognized early on. It feels good to be able to do something against this disease.

    — Parent who participated in the Fr1da study with his or her child

“We work closely with parents to explain T1D, what it means for their child, and recommend the best ways to care for them,” says Dr. Christiane Winkler, investigator for the study.
In 2015, Helmsley launched its T1D Prevention Initiative to investigate the early stages of development of the disease and identify new pathways to prevent it. Helmholtz Zentrum München was quickly identified as an ideal Helmsley partner given its public health mission, Europe’s cost-effective healthcare system, and Fr1da study lead Professor Annette-Gabriele Ziegler‘s strong interest and background in T1D prevention research. That same year, Helmsley began supporting a clinical trial that builds upon the Fr1da study and provides the opportunity for families whose children have multiple T1D-related autoantibodies to enroll their child in an intervention study, Fr1da Insulin Intervention study.  Participants of the intervention clinical trial are given oral insulin for 12 months to assess whether daily insulin doses can alter the immune system of young children and delay disease progression.

Looking ahead, the results of the intervention study can help to inform the viability of oral insulin as a prevention treatment for T1D in these children. Recently, target enrollment has expanded from 62 to 220 children, signaling affected families’ desire to participate. With continued support from Helmsley, the Fr1da study is benefiting more and more families and advancing the future of T1D prevention.

“This study can help us find out what mechanisms are useful to prevent diabetes in the future,” says Dr. Winkler. “And the families are very grateful to have the option to be prepared and take preventative measures.”

“We are so glad that our daughter Julia’s T1D was recognized early on. It feels good to be able to do something against this disease,” one parent said.