EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents
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...
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2025-01-01
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| author | Melanie Gündert Anette-Gabriele Ziegler Peter Achenbach Olga Kordonouri Agnieszka Szypowska Ezio Bonifacio Parth Narendran Christiane Winkler R Ribeiro Sandra Hummel Przemysława Jarosz-Chobot Emanuele Bosi R Lahesmaa K Casteels M Peakman P Jarosz-Chobot O Kordonouri Chantal Mathieu Vito Lampasona J F Raposo H Hyöty F Pociot João Filipe Raposo R Berner R Bergholdt E Bonifacio Flemming Pociot B Petersen J Van Rampelbergh L Overbergh B Van der Schueren V Lampasona C Winkler R Coelho O Cohen C Mathieu E Bosi Stefanie Arnolds Lut Overbergh Zdenek Sumnik A Koralova G Sebastiani Luisa Hoffmann Mirjam Kohls Regine Bergholdt Bianca K Hoefelschweiger Jurgen Vercauteren P Gillard J Vercauteren A G Ziegler P Achenbach F Haupt S Hummel T Pieber J Mader S Moitzi S Del Prato B Torbeyns Z Sumnik O Cinek V Neuman B Berka J Antvorskov J H Klaebel J E Laiho F Reschke T von dem Berge A Hommel A Loff G Gemulla N Zubizarreta L Piemonti F Dotta A Szypowska K Karczewski E Niemoeller M Baccara-Dinet K Fogh M I Buompensiere C Hurtado del Pozo E Latres G Agiostratidou |
| author_facet | Melanie Gündert Anette-Gabriele Ziegler Peter Achenbach Olga Kordonouri Agnieszka Szypowska Ezio Bonifacio Parth Narendran Christiane Winkler R Ribeiro Sandra Hummel Przemysława Jarosz-Chobot Emanuele Bosi R Lahesmaa K Casteels M Peakman P Jarosz-Chobot O Kordonouri Chantal Mathieu Vito Lampasona J F Raposo H Hyöty F Pociot João Filipe Raposo R Berner R Bergholdt E Bonifacio Flemming Pociot B Petersen J Van Rampelbergh L Overbergh B Van der Schueren V Lampasona C Winkler R Coelho O Cohen C Mathieu E Bosi Stefanie Arnolds Lut Overbergh Zdenek Sumnik A Koralova G Sebastiani Luisa Hoffmann Mirjam Kohls Regine Bergholdt Bianca K Hoefelschweiger Jurgen Vercauteren P Gillard J Vercauteren A G Ziegler P Achenbach F Haupt S Hummel T Pieber J Mader S Moitzi S Del Prato B Torbeyns Z Sumnik O Cinek V Neuman B Berka J Antvorskov J H Klaebel J E Laiho F Reschke T von dem Berge A Hommel A Loff G Gemulla N Zubizarreta L Piemonti F Dotta A Szypowska K Karczewski E Niemoeller M Baccara-Dinet K Fogh M I Buompensiere C Hurtado del Pozo E Latres G Agiostratidou |
| collection | DOAJ |
| 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 the EDENT1FI Master Protocol, site-specific protocols are developed and approved by local ethics committees (Technical University of Munich, Medical Faculty, Nr. 70/14; Medizinische Hochschule Hannover, Nr. 9588_BO_S_2021; Technische Universität Dresden, Nr. BO-EK-356082020; Center for Sundhed Region Hovedstaden, Nr. H-22053116; Swedish Ethical Review Authority, Nr. 2023-00312-01; National Health Service Health Research Authority and Health Care Research Wales, IRAS (Integrated Research Application System) project ID 309252; Italian National Institute of Health, National ethics committee for clinical trials of public research bodies (EPR) and other national public institutions, Prot. PRE BIO CE Nr. 0059835; Charles University in Prague, Ethics Committee for Multi-Centric Clinical Trials of the University Hopital Motol and 2nd Faculty of Medicine, Nr. 1271/23; Bioethics Committee at the Medical University of Warsaw, Nr. 21/2024 and KB/6/R/2024; Associação Protectora dos Diabéticos de Portugal, Nr. 211/2024). Results are disseminated through peer-reviewed journals and conference presentations and will be shared openly. |
| format | Article |
| id | doaj-art-b1ceae6df10c4486ab1728759728e122 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-b1ceae6df10c4486ab1728759728e1222025-01-09T18:15:08ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-088522EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents Melanie Gündert0Anette-Gabriele Ziegler1Peter Achenbach2Olga Kordonouri3Agnieszka Szypowska4Ezio Bonifacio5Parth Narendran6Christiane Winkler7R RibeiroSandra Hummel8Przemysława Jarosz-Chobot9Emanuele Bosi10R LahesmaaK CasteelsM PeakmanP Jarosz-ChobotO KordonouriChantal Mathieu11Vito Lampasona12J F RaposoH HyötyF PociotJoão Filipe Raposo13R BernerR BergholdtE BonifacioFlemming Pociot14B PetersenJ Van RampelberghL OverberghB Van der SchuerenV LampasonaC WinklerR CoelhoO CohenC MathieuE BosiStefanie Arnolds15Lut Overbergh16Zdenek Sumnik17A KoralovaG SebastianiLuisa Hoffmann18Mirjam Kohls19Regine Bergholdt20Bianca K Hoefelschweiger21Jurgen Vercauteren22P GillardJ VercauterenA G ZieglerP AchenbachF HauptS HummelT PieberJ MaderS MoitziS Del PratoB TorbeynsZ SumnikO CinekV NeumanB BerkaJ AntvorskovJ H KlaebelJ E LaihoF ReschkeT von dem BergeA HommelA LoffG GemullaN ZubizarretaL PiemontiF DottaA SzypowskaK KarczewskiE NiemoellerM Baccara-DinetK FoghM I BuompensiereC Hurtado del PozoE LatresG Agiostratidou1 Institute of Diabetes Research, Helmholtz Munich German Research Center for Environmental Health, Munich, Germany2 Forschergruppe Diabetes at Klinikum Rechts der Isar, Technical University of Munich School of Medicine, Munich, Germany1 Institute of Diabetes Research, Helmholtz Munich German Research Center for Environmental Health, Munich, Germany8 Kinderkrankenhaus auf der Bult, Hanover, Germany15 Department of Pediatrics, Medical University of Warsaw, Warsaw, Poland4 Center for Regenerative Therapies Dresden, Faculty of Medicine, TU Dresden, Dresden, Germany9 University of Birmingham, Birmingham, UK1 Institute of Diabetes Research, Helmholtz Munich German Research Center for Environmental Health, Munich, Germany1 Institute of Diabetes Research, Helmholtz Munich German Research Center for Environmental Health, Munich, Germany7 Department of Children`s Diabetology, Faculty of Medical Sciences in Katowice, Medical University of Silesia, Katowice, Poland5 Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy16 Department of Endocrinology, University Hospitals Leuven, Leuven, Belgium5 Diabetes Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy12 NOVA Medical School, Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal11 Department of Clinical Research, Translational Type 1 Diabetes Research, Steno Diabetes Center Copenhagen, Herlev, Denmark1 Institute of Diabetes Research, Helmholtz Munich German Research Center for Environmental Health, Munich, Germany10 Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium14 Department of Pediatrics, Second Faculty of Medicine, Charles University in Prague and Motol University Hospital, Prague, Czech Republic1 Institute of Diabetes Research, Helmholtz Munich German Research Center for Environmental Health, Munich, Germany1 Institute of Diabetes Research, Helmholtz Munich German Research Center for Environmental Health, Munich, Germany3 Novo Nordisk A/S, Soeborg, Denmark1 Institute of Diabetes Research, Helmholtz Munich German Research Center for Environmental Health, Munich, Germany10 Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, BelgiumIntroduction 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 the EDENT1FI Master Protocol, site-specific protocols are developed and approved by local ethics committees (Technical University of Munich, Medical Faculty, Nr. 70/14; Medizinische Hochschule Hannover, Nr. 9588_BO_S_2021; Technische Universität Dresden, Nr. BO-EK-356082020; Center for Sundhed Region Hovedstaden, Nr. H-22053116; Swedish Ethical Review Authority, Nr. 2023-00312-01; National Health Service Health Research Authority and Health Care Research Wales, IRAS (Integrated Research Application System) project ID 309252; Italian National Institute of Health, National ethics committee for clinical trials of public research bodies (EPR) and other national public institutions, Prot. PRE BIO CE Nr. 0059835; Charles University in Prague, Ethics Committee for Multi-Centric Clinical Trials of the University Hopital Motol and 2nd Faculty of Medicine, Nr. 1271/23; Bioethics Committee at the Medical University of Warsaw, Nr. 21/2024 and KB/6/R/2024; Associação Protectora dos Diabéticos de Portugal, Nr. 211/2024). Results are disseminated through peer-reviewed journals and conference presentations and will be shared openly.https://bmjopen.bmj.com/content/15/1/e088522.full |
| spellingShingle | Melanie Gündert Anette-Gabriele Ziegler Peter Achenbach Olga Kordonouri Agnieszka Szypowska Ezio Bonifacio Parth Narendran Christiane Winkler R Ribeiro Sandra Hummel Przemysława Jarosz-Chobot Emanuele Bosi R Lahesmaa K Casteels M Peakman P Jarosz-Chobot O Kordonouri Chantal Mathieu Vito Lampasona J F Raposo H Hyöty F Pociot João Filipe Raposo R Berner R Bergholdt E Bonifacio Flemming Pociot B Petersen J Van Rampelbergh L Overbergh B Van der Schueren V Lampasona C Winkler R Coelho O Cohen C Mathieu E Bosi Stefanie Arnolds Lut Overbergh Zdenek Sumnik A Koralova G Sebastiani Luisa Hoffmann Mirjam Kohls Regine Bergholdt Bianca K Hoefelschweiger Jurgen Vercauteren P Gillard J Vercauteren A G Ziegler P Achenbach F Haupt S Hummel T Pieber J Mader S Moitzi S Del Prato B Torbeyns Z Sumnik O Cinek V Neuman B Berka J Antvorskov J H Klaebel J E Laiho F Reschke T von dem Berge A Hommel A Loff G Gemulla N Zubizarreta L Piemonti F Dotta A Szypowska K Karczewski E Niemoeller M Baccara-Dinet K Fogh M I Buompensiere C Hurtado del Pozo E Latres G Agiostratidou EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents BMJ Open |
| title | EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents |
| title_full | EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents |
| title_fullStr | EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents |
| title_full_unstemmed | EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents |
| title_short | EDENT1FI Master Protocol for screening of presymptomatic early-stage type 1 diabetes in children and adolescents |
| title_sort | edent1fi master protocol for screening of presymptomatic early stage type 1 diabetes in children and adolescents |
| url | https://bmjopen.bmj.com/content/15/1/e088522.full |
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