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Winkler, C. ; Friedl, N. ; Abt, R.* ; Ackermann, K. ; Bently, J.* ; Braig, S.* ; Brämswig, S.* ; Dunstheimer, D.* ; Ermer, U.* ; Ewald, D.* ; Gerstl, E.M.* ; Hammersen, J.* ; Haupt, F. ; Hergl, M. ; Hubmann, M.* ; Hummel, S. ; Jochem, B.* ; Knopff, A. ; Lange, K.* ; Lwowsky, D.* ; Nellen-Hellmuth, N.* ; Prey, B.* ; Rettner, D.* ; Schill, S. ; Schmidt, S.* ; Scholz, M. ; Sindichakis, M.* ; Stock, J. ; Stricker, D.* ; Völkl, T.M.K.* ; Warncke, K.* ; Weber, L.* ; Weiss, A. ; Bonifacio, E. ; Achenbach, P. ; Ziegler, A.-G.

Screening children for early-stage type 1 diabetes.

JAMA, DOI: 10.1001/jama.2026.6085 (2026)
DOI PMC
Open Access Green as soon as Postprint is submitted to ZB.
IMPORTANCE: Detecting type 1 diabetes in presymptomatic stages is essential for therapies aimed at delaying clinical onset. OBJECTIVE: To estimate early-stage (stage 1 or 2) type 1 diabetes prevalence and disease progression to clinical (stage 3) type 1 diabetes in children in a population-based screening study. DESIGN, SETTING, AND PARTICIPANTS: From February 2015 to July 2025, children living in Bavaria, Germany, were screened for early-stage type 1 diabetes. Screening was conducted by 716 primary care pediatricians. Screening was performed once in children aged 1.75 to 5.99 years until March 2019 and was subsequently expanded to include up to 2 screenings in children aged 1.75 to 10.99 years. Families of children with early-stage disease were offered diabetes education, metabolic staging, and longitudinal monitoring in 18 specialized diabetes centers. EXPOSURES: Measurement of islet autoantibodies. MAIN OUTCOMES AND MEASURES: The primary outcome was early-stage type 1 diabetes, defined as 2 or more autoantibodies against insulin, glutamic acid decarboxylase, islet antigen-2, or zinc transporter 8 confirmed in consecutive blood samples, with categorization into stages 1 (normoglycemia) and 2 (dysglycemia) and progression to clinical (stage 3) diabetes. RESULTS: Among 220 476 enrolled children (median [IQR] age, 3.1 [2.2-5.0] years; 106 952 [48.7%] females), 590 had presymptomatic early-stage type 1 diabetes at first screening (adjusted population frequency, 0.3% [95% CI, 0.28%-0.32%]) with prevalences of 0.23% for stage 1 and 0.06% for stage 2 type 1 diabetes. Repeat screening in 11 726 children after a median of 3.3 years identified 29 additional cases. During a median follow-up of 5.7 years, 212 children with an early-stage diagnosis at first screening, 5 with a diagnosis at rescreening, and 43 without an early-stage diagnosis developed clinical (stage 3) diabetes. Five-year progression from early-stage to clinical diabetes was 36.2% (95% CI, 31.2%-40.8%; annualized rate, 9.6%), and not significantly different between children with and without a first-degree family history (P = .54). CONCLUSIONS AND RELEVANCE: General population screening of children identified early-stage type 1 diabetes and similar progression rates to clinical diabetes between children with and without a first-degree family history. These findings inform disease-modifying therapy trials and suggest that screening can be considered beyond genetically selected populations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04039945.
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Publication type Article: Journal article
Document type Scientific Article
Keywords Islet Autoantibodies; Young-children; Risk; Autoimmunity; Elisa
ISSN (print) / ISBN 0098-7484
e-ISSN 1538-3598
Journal JAMA: Journal of the American Medical Association
Publisher American Medical Association
Publishing Place 330 N Wabash Ave, Ste 39300, Chicago, Il 60611-5885 Usa
Reviewing status Peer reviewed
Institute(s) Institute of Diabetes Research (IDF)
Institute of Pancreatic Islet Research (IPI)
Grants German Center for Diabetes Research
EASD-Novo Nordisk Foundation Diabetes Prize for Excellence
Bavarian Ministry of Economic Affairs, Energy, and Technology (Digital Lab)
Deutsche Diabetiker Bund e.V.
Leona M. and Harry B. Helmsley Charitable Trust
LifeScience Stiftung
Breakthrough T1D (formerly Juvenile Diabetes Research Foundation International)