The Fr1da model project is unique by its magnitude in global diabetes research: A total of 100,000 children throughout Bavaria will be tested for beta cell autoantibodies, biomarkers of early type 1 diabetes*, at their U7, U7a, U8 or U9 child health examinations performed by their pediatrician. Early detection of type 1 diabetes, when it is asymptomatic, can reduce the risk for life-threatening metabolic imbalance (ketoacidosis) and the admission to a hospital’s intensive care unit, according to the first conclusion of the scientists at the Institute of Diabetes Research. Throughout Germany, every third child diagnosed with type 1 diabetes requires treatment for ketoacidosis at the time of the diagnosis, but so far none of the children who have been diagnosed with the Fr1da early detection test have suffered from metabolic imbalance.
„Thanks to the enormous support from the dedicated Bavarian pediatricians, implementation of the Fr1da Study has been extremely gratifying,“ reports Prof. Ziegler on the first results. „A screening test for early type 1 diabetes is feasible in this age group throughout the entire population.“ So far, 39 percent of all Bavarian pediatricians have participated in the project. At the time of the first data evaluation in November, 26,760 children between the ages of two and five years had been examined. This age group was chosen because, already at this age, 80 percent of patients who develop type 1 diabetes during childhood have 2 or more beta cell autoantibodies. An early stage of type 1 diabetes was diagnosed in 4 out of every 1000 children tested; 105 children in total so far.
“We are extremely optimistic with the latest data from the Fr1da study, and believe we are treading a new path of preventive health care,” said Jessica Dunne, Ph.D., director and program lead for JDRF’s Prevention Program. “We are grateful to the Institute of Diabetes Research. The success of this study marks a significant milestone and could help thwart the deadly condition of diabetic ketoacidosis (DKA) from occurring at full onset of the disease as well as to provide a framework for interventions to prevent type 1 diabetes from ever happening.”
Parents overwhelmingly taking advantage of the teaching and care program
When diagnosed, the children and their families are offered participation in a four-hour teaching course in one of the 16 pediatric diabetes centers spread throughout Bavaria so that they may attend close to their homes. The families overwhelmingly take advantage of this offer: all but two families have chosen to participate. The experienced teams answered questions and helped the parents come to terms with the early diabetes diagnosis. In addition to factual information, many practical tips for day-to-day life were given. The illustrated Fr1da brochure that is provided to all families, prepares the families for future insulin treatment and day-to-day life with type 1 diabetes. Based on sound experience with patients, the brochure and teaching seeks to convey a positive outlook of life with type 1 diabetes so that the parents and children are provided security and feel cared for.
A focus on the emotional condition of the families
An important measure undertaken in Fr1da is how effectively knowledge is conveyed to the teaching course participants and how well the families are able to come to terms with the diagnosis. Standardized psychological questionnaires supplemented by personal discussions are used to assess this. A first assessment showed that, not unexpectedly, no parent was unaffected by the diagnosis in their child. However, thanks to the care and support provided within the study, there have so far been no indications that the mothers, fathers or children have suffered from severe emotional stress.**
“With the Fr1da Study we want to set new standards in the diagnosis and treatment of type 1 diabetes by a diagnosis in the early, asymptomatic stage, and the provision of comprehensive medical and psychological care for the affected families,” Ziegler states.
The Fr1da type 1 diabetes early detection campaign was started in February 2015 under the auspices of the Bavarian Minister of Health Melanie Huml in order to prepare the ground for standard early type 1 diabetes examination in Bavaria. Here for the first time, parents have the opportunity to have their children between the ages of two and five years examined for pancreatic beta cell autoantibodies in their blood collected during regular pediatric visits at no cost. The detection of autoantibodies to two or more beta cell proteins is diagnostic for type 1 diabetes in an early stage. Diagnosed children and their parents receive personalized teaching, care and consultation, and are offered regular follow-up examinations and participation in a clinical type 1 diabetes prevention trial.
Glucose metabolism is checked with an oral glucose tolerance test (oGTT) and an HbA1c measurement within six weeks of diagnosis. In an oral glucose tolerance test, the blood sugar level is measured after fasting, and then one and two hours after the ingestion of a drink containing sugar. Levels over 200 mg/dl indicate manifest clinical diabetes. The glucose tolerance is said to be impaired if the two-hour plasma glucose levels lie between 140 and 200 mg/dl combined with a fasting blood sugar level of less than 126 mg/dl. HbA1c reflects the average blood sugar concentration during the most recent two months. The higher the proportion of HbA1c, the more dissolved sugar is in the blood. In healthy people, this value is generally between four and six percent. A value that exceeds 6.5 percent is an indication of manifest clinical diabetes. These and other medical examinations are repeated at regular intervals. The parents are also offered an opportunity for their child to take part in clinical trial assessing oral insulin treatment for type 1 diabetes prevention in the framework of the Fr1da Insulin Intervention Study.
*By detecting autoantibodies in the blood that are against insulin, GAD65, zinc transporter 8, or IA-2, it is possible to diagnose type 1 diabetes in an early stage when the autoimmune disease has no clinical symptoms.
**Nevertheless, should psychological support be required for a family at some point, appropriate help is possible in the framework of the Fr1da Study. Importantly, the longer term effects that the early type 1 diabetes diagnosis has are investigated by regular questionnaires in order to be able to assess the need of the families.
Raab, J. et al. (2016). Capillary blood islet autoantibody screening for identifying pre-type 1 diabetes in the general population: Design and initial results of the Fr1da study, BMJ Open, doi: 10.1136/bmjopen-2016-011144
The Helmholtz Zentrum München, the German Research Center for Environmental Health, pursues the goal of developing personalized medical approaches to the prevention and therapy of major common diseases such as diabetes and lung disease. To achieve this, it investigates the interaction of genetics, environmental factors and lifestyle. The Helmholtz Zentrum München has about 2,300 staff members and is headquartered in Neuherberg in the north of Munich. It is a member of the Helmholtz Association, a community of 18 scientific-technical and medical-biological research centers with a total of about 37,000 staff members. The Helmholtz Zentrum München is a partner in the German Center for Diabetes Research.
The Institute of Diabetes Research (IDF) focuses on the pathogenesis and prevention of type 1 diabetes and type 2 diabetes as a long-term effect of gestational diabetes. A top-priority project is the development of an insulin vaccination against type 1 diabetes. In large-scale, long-term studies the IDF examines the implication of genes, environmental factors and the immune system in the pathogenesis of type 1 diabetes. Using data from the BABYDIAB cohort, which was established in 1989 as the world’s first prospective diabetes birth cohort, risk genes and antibody profiles can both be identified. This allows predictions about the development and onset of type 1 diabetes and will change the classification and the time of diagnosis. The IDF is part of the Helmholtz Diabetes Center (HDC).
Contact for the media:
Department of Communication, Helmholtz Zentrum München – German Research Center for Environmental Health (GmbH), Ingolstädter Landstr. 1, 85764 Neuherberg – Tel. +49 89 3187 2238 – Fax: +49 89 3187 3324 – E-mail:
Scientific contact at Helmholtz Zentrum München:
Prof. Dr. Anette-Gabriele Ziegler, Helmholtz Zentrum München – German Research Center for Environmental Health (GmbH), Institute of Diabetes Research, Ingolstädter Landstr. 1, 85764 Neuherberg – Tel. +49 89 3187 3405 – E-mail: