Dear Reader, Welcome to the very first issue of our Fr1da Science Newsletter. From now on, we will keep you updated on the most important developments of the Fr1da study and research. If you are interested in receiving this newsletter in the future, please register HERE.
Since the start of the Fr1da study, a total of 149,353 children have participated in the largest population-based screening of islet autoantibodies for an early diagnosis of type 1 diabetes with the aim to
minimize psychological burden and uncertainty by training and intensive support of those affected
help to set new standards for early diagnosis of type 1 diabetes
identify children who benefit from immune-based therapies to prevent insulin dependence
Screening for islet autoantibodies is offered to
children aged 2 and 10 years in Bavaria, Germany by primary care pediatricians during well-child visits
first- and second-degree relatives of patients with type 1 diabetes nationwide between the ages of 1 and 21 years
Each child can be tested twice in the above age range, unless an early stage of type 1 diabetes has been diagnosed. Moreover, there must be at least 12 months between the two tests.
Please inform your patients and parents. To date, only about 1% of all families take advantage of the second testing opportunity!
The Fr1da study started in 2015 and was modified and extended in 2019 as Fr1daplus. Modifications included raising the upper age limit for screening from 5 to 10 years, screening for LIPS IAA in addition to the 3-screen ELISA, and follow-up of children with single islet autoantibodies for spreading to 2 or more islet autoantibodies for up to 3 years.
In addition, the Fr1daplus study offers an optional free SARS-CoV-2 antibody test for determining antibody response to coronavirus to all participants of the study. For more information about Fr1da see provided references below or read the
The screening of 149,353 children identified 441 (0.3%) to have presymptomatic type 1 diabetes (see figure below).
Early diagnosis can prevent life-threatening diabetic ketoacidosis in children: Diabetic ketoacidosis (DKA) is a severe complication at the onset of typ1 diabetes with a prevalence of around 20% in Germany (link to article). In the Fr1da study, the prevalence of DKA was drastically reduced to 1.2% in children participating in the Fr1da diabetes care program.
Fr1da study participations per administrative district in Bavaria
Islet autoantibodies are measured using a stepwise approach:
FR1DA DIABETES CARE PROGRAM
For children with 2 or more islet autoantibodies (presymptomatic type 1 diabetes), the Fr1da study provides an individual Fr1da diabetes care program and the participation in intervention trials (if available):
Fr1da diabetes care program:
The program starts with metabolic staging, an assessment of psychological stress associated with the diagnosis of presymptomatic type 1 diabetes and diabetes education at a pediatric diabetes clinic /specialist close to the family’s residence.
Metabolic staging: An oral glucose tolerance test (OGTT) is performed for staging.
Depending on the OGTT result, presymptomatic type 1 diabetes is classified as stage 1, 2, or 3 type 1 diabetes as previously defined (see below). On the basis of the individual disease stage, a monitoring plan is provided for future visits at 2 to 6-month intervals. The monitoring plan will be adjusted according to the child’s glucose tolerance.
Monitoring plan of the Fr1da diabetes care program:
The Bavarian State Association of Pediatricians: 663 registered pediatricians
PaedNetz Bayern e. V.
The Bavarian State Office for Health and Care
Pediatric diabetes clinics: 17 contracted partner clinics in 13 cities in Bavaria, Germany (Augsburg, Bayreuth, Deggendorf, München, Neuburg, Nürnberg, Passau, Rosenheim, Schweinfurt, Traunstein, Weiden, Wurzburg, Kempten).
FR1DA & SAR-S-CoV-2 ANTIBODY MEASUREMENT
Since April 2020, optional antibody tests to SARS-CoV-2 has been offered to children aged 1 to 18 years participating in the type 1 diabetes screening of the Fr1da study. By May 2021, we have now tested up to 35,053 blood smaples of our study participants for antibodies against SARS-CoV-2. The study results are available in a dashboard along with an overview of the geographic disttribution of antibody abundance. The figures are updated monthly!
Click here to access the Fr1da & SARS-CoV-2 Dashboard
John M Wentworth, The Walter and Eliza Hall Institute of Medical Research, Department of Population Health and Immunity in Parkville, Australia, received de-identified Fr1da study data as of 30.04.2020, including participant age, gender, body mass index, HbA1c, antibody results, glucose and C-peptide during OGTT, duration of follow-up and diabetes status. The data will be used to further validate a simple model to predict disease progression from stage 1 or 2 to stage 3 diabetes together with datasets from Trialnet, DPT, TEDDY and Fr1da. Click here to read the full paper.
Annette Peters, Institute of Epidemiology, Helmholtz Zentrum München, for an analysis looking at effects of environmental exposures (air pollution, noise, temperature, greenness) on the prevalence of presymptomatic type 1 diabetes in children in Bavaria, Germany.
Florian Karl, Michael Laxy, Institute of Health Economics and Health Care Management, Helmholtz Zentrum München, for cost analysis of the Fr1da public health screening for islet autoantibodies in Bavaria, Germany.
Sarah Shuck and Bart Roep, Beckman Research Institute at City of Hope, received serum samples from participants of the Fr1da study, including children with or without presymptomatic type 1 diabetes, to measure novel biomarkers (methylglyoxal adducts) produced by metabolic pathways thought to be upregulated early in type 1 diabetes development. The goal is to determine whether these biomarkers can be associated with T1D stage and used to predict the risk of progression from presymptomatic to clinical type 1 diabetes.