Screening Children for Early-Stage Type 1 Diabetes.
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Winkler Christiane, Friedl Nadine, Abt Renate, Ackermann Kathrin, Bently Julia, Braig Sonja, Brämswig Susanne, Dunstheimer Desiree, Ermer Uwe, Ewald Dominik, Gerstl Eva-Maria, Hammersen Johanna, Haupt Florian, Hergl Maja, Hubmann Michael, Hummel Sandra, Jochem Benedikt, Knopff Annette, Lange Karin, Lwowsky Dominik, Nellen-Hellmuth Nicole, Prey Birgit, Rettner Daniela, Schill Sarah, Schmidt Silke, Scholz Marlon, Sindichakis Marina, Stock Joanna, Stricker Dominik, Völkl Thomas M K, Warncke Katharina, Weber Leonie, Weiss Andreas, Bonifacio Ezio, Achenbach Peter, Ziegler Anette-Gabriele
Аннотация
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.