| Title: |
EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents |
| Authors: |
Hoffmann L.; Kohls M.; Arnolds S.; Achenbach P.; Bergholdt R.; Bonifacio E.; Bosi E.; Gundert M.; Hoefelschweiger B. K.; Hummel S.; Jarosz-Chobot P.; Kordonouri O.; Lampasona V.; Narendran P.; Overbergh L.; Pociot F.; Raposo J. F.; Sumnik Z.; Szypowska A.; Vercauteren J.; Winkler C.; Mathieu C.; Ziegler A. -G.; Gillard P.; Casteels K.; Schueren B. V. D.; Ziegler A. G.; Piemonti L. |
| Contributors: |
Hoffmann, L.; Kohls, M.; Arnolds, S.; Achenbach, P.; Bergholdt, R.; Bonifacio, E.; Bosi, E.; Gundert, M.; Hoefelschweiger, B. K.; Hummel, S.; Jarosz-Chobot, P.; Kordonouri, O.; Lampasona, V.; Narendran, P.; Overbergh, L.; Pociot, F.; Raposo, J. F.; Sumnik, Z.; Szypowska, A.; Vercauteren, J.; Winkler, C.; Mathieu, C.; Ziegler, A. -G.; Gillard, P.; Casteels, K.; Schueren, B. V. D.; Ziegler, A. G.; Piemonti, L. |
| Publisher Information: |
BMJ Publishing Group |
| Publication Year: |
2025 |
| Subject Terms: |
Community child health; General diabetes; Paediatric endocrinology; PUBLIC HEALTH |
| Description: |
Introduction The identification of type 1 diabetes at an early presymptomatic stage has clinical benefits. These include a reduced risk of diabetic ketoacidosis (DKA) at the clinical manifestation of the disease and a significant reduction in clinical symptoms. The European action for the Diagnosis of Early Non-clinical Type 1 diabetes For disease Interception (EDENT1FI) represents a pioneering effort to advance early detection of type 1 diabetes through public health screening. With the EDENT1FI Master Protocol, the project aims to harmonise and standardise screening for early-stage type 1 diabetes and care. Methods and analysis Public health islet autoantibody screening is conducted in the Czech Republic, Denmark, Germany, Italy, Poland, Portugal, Sweden and the UK. Between November 2023 (start date) and October 2028 (planned end date), an estimated number of 200 000 children and adolescents aged 1-17 years are expected to be screened. Screening is performed in capillary blood, examining different islet autoantibodies (autoantibodies against insulin, glutamic acid decarboxylase-65, insulinoma-associated antigen-2 and/or zinc transporter-8). Positive screening results undergo confirmation through a second antibody method. A second (venous) blood sample is requested if at least two autoantibodies are detected, to confirm the autoantibody status. Children and adolescents with confirmed two or more autoantibodies are invited to metabolic staging (oral glucose tolerance test, haemoglobin A1c (HbA1c), random glucose, optionally continuous glucose monitoring); an educational programme and recommendations for monitoring are provided. The feasibility and acceptability of screening are evaluated by feedback questionnaires. Pseudonymised data is collated in the EDENT1FI Registry. Study outcomes include country-specific screening rates, prevalences of stage 1 and stage 2 type 1 diabetes, number in EDENT1FI Registry, proportion with DKA and symptoms at clinical diagnosis and median HbA1c. Ethics and dissemination Following ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/39753267; info:eu-repo/semantics/altIdentifier/wos/WOS:001391488400001; volume:15; issue:1; numberofpages:10; journal:BMJ OPEN; https://hdl.handle.net/20.500.11768/180758; https://bmjopen.bmj.com/content/15/1/e088522 |
| DOI: |
10.1136/bmjopen-2024-088522 |
| Availability: |
https://hdl.handle.net/20.500.11768/180758; https://doi.org/10.1136/bmjopen-2024-088522; https://bmjopen.bmj.com/content/15/1/e088522 |
| Rights: |
info:eu-repo/semantics/openAccess ; license:Creative commons ; license uri:http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Accession Number: |
edsbas.7D393D02 |
| Database: |
BASE |