Type 1 Diabetes: Number of Participants for Fr1da Insulin Intervention Study Has Been Increased

Fr1da, Fr1dolin, Freder1k – these new screening tests for the early detection of type 1 diabetes in Bavaria, Lower Saxony and Saxony have one thing in common: They aim to identify children with a high disease risk or an asymptomatic early stage of the autoimmune disease. In addition to these screening projects, the Institute of Diabetes Research of the DZD partner Helmholtz Zentrum München offers children with an early stage of type 1 diabetes participation in a study on the prevention of the clinical disease. The number of participants in this "Fr1da Insulin Intervention Study" has now been increased from 62 to 220.

Nine out of ten children who develop diabetes do not have any family members with type 1 diabetes. However, by measuring diabetic-specific autoantibodies, the disease can be predicted or detected early. To this end, the first population-wide early detection screening test for type 1 diabetes, the Fr1da study1, was initiated in Bavaria in 2015. Approximately four out of every 1,000 of the two to five-year-olds examined in Fri1da have early stage type 1 diabetes. "This diagnosis can already be made without clinical symptoms if several diabetes-specific autoantibodies are detectable in the blood," said PD Dr. Peter Achenbach of the Institute of Diabetes Research.

Confronting the immune system with high-dose oral insulin
In 2016, the initiators of the Bavarian pilot project Fr1da, the Institute of Diabetes Research at Helmholtz Zentrum München, launched the Fr1da Insulin Intervention Study to provide children with an early stage of type 1 diabetes an early treatment option. The study participants take insulin powder or a placebo powder every day. Like in desensitization, the aim is to confront the immune system with insulin via the gastrointestinal tract, thus eliciting a protective, insulin-specific regulative immune response. Ideally, this would have the effect of preventing the development of clinical-symptomatic type 1 diabetes. In a pilot study (Pre-POINT Study *), the preventive treatment with oral insulin in children without diabetes-specific autoantibodies was promising.

The research team led by Professor Anette-Gabriele Ziegler has now increased the number of participants of the Fr1da Insulin Intervention Study from 62 to 220 subjects. The originally planned number of participants was already reached in the first year of study. “The increase will allow us to examine whether an insulin-specific regulatory immune response induced by the treatment prevents the progress of the disease or protects against the onset of disturbed glucose tolerance2 and clinical diabetes,” said Ziegler, commenting on the decision to increase the number of participants. 

Conditions for participation
Children aged 2 to 12 years who have multiple diabetes-specific autoantibodies and normal blood glucose levels can participate in the Fr1da Insulin Intervention Study. For example, older siblings of children from the Fr1da study as well as children from families of the Freder1k study3 or the Fr1dolin study4 may participate. It does not matter whether a family member already has type 1 diabetes or not. The study is expected to continue until mid-2018.

Registration and information:
Institute of Diabetes Research
Helmholtz Zentrum München
Univ.-Prof. Dr. med. Anette-Gabriele Ziegler
Phone: 0800 – 4 64 88 35 (toll free)

1 The Fr1da study is the world's first population-wide early detection study for type 1 diabetes. The Fr1da study is aimed at all Bavarian children aged 2 to 5 years. It was launched in 2015 under the patronage of the Bavarian health minister Melanie Huml and with the participation of the Bavarian pediatricians. If there are multiple endogenous diabetes-specific antibodies, type 1 diabetes is present in an early stage. The Fr1da study is funded by the JDRF, the LifeScience Foundation, the Bavarian Ministry of Health, German Diabetes Aid, the B. Braun Foundation, the BKK health insurance companies and the German Diabetes Foundation.

2 A "disturbed glucose tolerance" is understood to mean abnormally elevated blood glucose levels at the two-hour measurement in the oral glucose tolerance test (OGTT) in the range of 140 to 200 mg / dl.

3 In Saxony in the Freder1k study, newborns are being tested for diabetes risk genes. The study is coordinated by the Center for Regenerative Therapies (CRTD) of TU Dresden in cooperation with the Carl Gustav Carus Dresden University Hospital, Leipzig University Hospital and other participating clinics as well as the Institute of Diabetes Research at Helmholtz Zentrum München.

4 In the Fr1dolin study, two to six-year-olds from Lower Saxony are tested for two diseases: In addition to the early stage of type 1 diabetes, the children are also screened for the presence of familial hypercholesterolemia. The study is coordinated by the Diabetes Center at the Children's and Youth Hospital Auf der BULT in Hannover in cooperation with the Department of Medical Psychology at the Hannover Medical School (MHH) and the Institute of Diabetes Research, Helmholtz Zentrum München.

* Fundamental publications on the Pre-POINT Study:
Ezio Bonifacio, PhD; Anette-G. Ziegler, MD; Georgeanna Klingensmith, MD; Edith Schober, MD; Polly J. Bingley, MD; Marietta Rottenkolber, Dipl Stat; Anke Theil, PhD; Anne Eugster, PhD; Ramona Puff, PhD; Claudia Peplow, Dipl EocTroph; Florian Buettner, PhD; Karin Lange, PhD; Jörg Hasford, MD; Peter Achenbach, MD; for the Pre-POINT Study Group: Effects of High-Dose Oral Insulin on Immune Responses in Children at High Risk for Type 1 Diabetes. The Pre-POINT Randomized Clinical Trial. JAMA. 2015; 313(15):1-10. doi:10.1001/jama.2015.2928