GPPAD Study Group
Please find detailed information on the study group for GPPAD-03 below.
GPPAD-POInT Study Group Authors
GPPAD-Coordinating Center (CC)
Peter Achenbach 1,2,3, Stefanie Arnolds 1, Karina Blasius1, Ezio Bonifacio3,4,5,6, Michaela Dilong1, Veronika Fendt1, Melanie Gündert 1, Florian Haupt1, Martin Heigermoser1, Maja Hergl1, Elisabeth Huber1, Sandra Hummel1, Nadine Klein1, Ramona Lickert1, Claudia Matzke1, Lorena Müller1, Rebecca Niewöhner1, Marlon Scholz1, Katharina Schütte-Borkovec1, Merve Vurucu 1, José Maria Zapardiel Gonzalo1, Anette-Gabriele Ziegler 1,2,3
Statistical analysis team
Thomas Lang7, Markus Pfirrmann7 (independent statistician, DSMB), Andreas Weiß1 (trial statistician)
Screening for genetic T1D risk (GPPAD-02)
Belgium, Flanders: Kristina Casteels8,9, An Jacobs8, Charlien Jannsen10, Hilde Morobé10, Jasmin Paulus10, Anne Rochtus8,9, Natalie Van den Driessche10, Renka Van Heyste10, Veerle Vanhuyse11, Brontë Vrancken10
Germany, Saxony: Uta Ceglarec12, Petrina Delivani4, Franziska Ehrlich4, Angela Hommel4, Anja Loff4, Peter Mirtschink14, Pauline Wimberger15, Nicole Zubizarreta4
Germany, Lower Saxony: Frank Roloff16
Germany, Bavaria: Annika Fehn1, Stefanie Jacobson1,2, Elisabeth Huber1, Christiane Winkler1,3
Poland, Voivodship Mazowieckie: Marta Krysicka17, Mariusz Ołtarzewski17, Agnieszka Szypowska17,18, 19
Sweden, Skåne Region: Helena Elding Larsson20,21, Ida Jönsson20, Dorota Lacki20,21, Markus Lundgren20,22, Hannah Nenonen20,21
UK, Oxford Region: Parvinder Aley23, Ian Smith24, Matthew Snape25, Nazia Taj24, John A Todd26, Manu Vatish27, Tabitha Wishlade27
POInT study (GPPAD-03)
Belgium, Leuven: Kristina Casteels8,9, Janne Houben8, An Jacobs8, Charlien Jannsen10, Jasmin Paulus10, Anne Rochtus8,9, Natalie Van den Driessche10, Veerle Vanhuyse11, Brontë Vrancken10
Germany, Dresden: Sari Arabi4,13, Reinhard Berner13, Ruth Blechschmidt4, Ezio Bonifacio2,4,5,6, Sevina Dietz4, Franziska Ehrlich4, Gita Gemulla4,13, Sophie Heinke4,13, Raphael Hoffmann4,13, Angela Hommel4, Susan Kowal4, Franziska Lange4,13, Anja Loff4, Marie-Luise Michael4,13, Bianca Schlee4, Marc Weigelt4, Nicole Zubizarreta4
Germany, Hanover: Laura Galuschka16, Olga Kordonouri16, Carolin Kruse16, Sarah Landsberg16, Erika Marquardt16, Mareike Niemeyer16, Felix Reschke16, Frank Roloff16, Bianca Schmidt16, Kerstin Semler16, Thekla von dem Berge16, Jantje Weiskorn16
Germany, Munich: Peter Achenbach 1,2,3, Melanie Bunk 1, Willi Grätz1,2, Anna Hofelich 2, Annette Knopff 1, Annette Munzinger 1, Claudia Ramminger1, Franziska Reinmüller 2, Cigdem Sanverdi1, Katharina Sarcletti 1 , Sarah Schill2, Anette-Gabriele Ziegler1,2,3
Poland, Warsaw: Adrianna Cieloch18, Wiktoria Czerwińska18, Sylwia Dybkowska18, Natalia Dziedzic18, Elżbieta Górska18,19, Lidia Groele18,19, Agnieszka Mroczek18, Dorota Owczarek18, Katarzyna Popko18,19, Agnieszka Szypowska17, 18,19, Beata Zduńczyk18, Anna Zych18
Sweden, Malmö: Sofie Alström Mortin20, Susanne Dahlberg22 Helena Elding Larsson20,21, Lina Fransson20,21, Malin Goldman-Tsubarah20,21, Markus Lundgren20,22, Jessica Melin20,21, Hannah Nenonen20,21, Kobra Rhamati20,21, Falastin Salami20,21, Carina Törn28
UK, Oxford: Parvinder Aley23, Owen Bendor-Samuel23, Rachel E J Besser25,29,30, Rachel Craik23, Sophia Hawkins.23,32, Alice Lelliott23,32, Helen Ratcliffe23,32, Matthew Snape29, John A Todd24, Sophie Vernon23,32, Connor Whelan23,32, Louise Willis23
Affiliations
1 Institute of Diabetes Research, Helmholtz Munich, German Research Center for Environmental Health, Neuherberg, Germany
2 Technical University of Munich, School of Medicine and Health, Forschergruppe Diabetes, TUM University Hospital, Munich, Germany
3 German Center for Diabetes Research (DZD e.V.), Neuherberg, Germany
4 Center for Regenerative Therapies Dresden, Technische Universität Dresden, Dresden, Germany
5 Paul Langerhans Institute Dresden of Helmholtz Munich at University Hospital Carl Gustav Carus, Faculty of Medicine, Technische Universität Dresden, Dresden, Germany
6 Institute of Diabetes and Obesity (IDO), Helmholtz Munich, German Research Center for Environmental Health, Neuherberg, Germany
7 Institute for Medical Information Processing, Biometry, and Epidemiology (IBE), Faculty of Medicine, Ludwig-Maximilians-Universität, Munich, Germany
8 Department of Pediatrics, University Hospital Gasthuisberg, Leuven, Belgium
9 Department of Development and Regeneration, KU Leuven, Leuven, Belgium
10 Research & Development Endocrinology, University Hospital Gasthuisberg, Leuven, Belgium
11 Clinical & Experimental Endocrinology, KU Leuven, Leuven, Belgium
12 Department of Medicine, University of Leipzig, Leipzig, Germany
13 Department of Pediatrics, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
14 Institute for Clinical Chemistry and Laboratory Medicine, Faculty of Medicine, Technische Universität Dresden, Dresden, Germany
15 Department of Obstetrics and Gynecology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
16 Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany
17 Department of Screening and Metabolic Diagnostics, Institute of Mother and Child, Warsaw, Poland
18 Department of Paediatric Diabetology and Paediatrics, The Children’s Clinical Hospital Józef Polikarp Brudziński, University Clinical Centre of the Medical University of Warsaw, Warsaw, Poland
19 Department of Paediatric Diabetology and Paediatrics, Medical University of Warsaw, Warsaw, Poland
20 Unit for Pediatric Endocrinology, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden
21 Department of Paediatrics, Skåne University Hospital, Malmö/Lund, Sweden
22 Department of Paediatrics, Skåne University Hospital, Kristianstad, Sweden
23 Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK
24 Oxford Screening Laboratory, Department of Clinical Biochemistry, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
25 Department of Paediatrics, University of Oxford, Oxford, UK
26 Diabetes and Inflammation Laboratory, Centre for Human Genetics, Nuffield Department of Medicine, NIHR Oxford Biomedical Research Centres, University of Oxford, Oxford, UK
27 Nuffield Department of Women’s & Reproductive Health, University of Oxford, John Radcliffe Hospital, Oxford, UK
28 Unit for Celiac and Diabetes, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden
29 Centre for Human Genetics, Nuffield Department of Medicine, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford UK
30 Department of Paediatric Diabetes and Endocrinology, Oxford Children’s Hospital, The John Radcliffe, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
32 NIHR Oxford Biomedical Research Centre, Oxford, UK
Declarations
Acknowledgements
We sincerely thank the participating families for their contribution to type 1 diabetes research and their support in advancing therapies for prevention. We also greatly acknowledge the following support:
GPPAD coordination center: Robin Assfalg, Gertrud Goppel, Bianca Höfelschweiger, Stephanie Löbner, Claudia Peplow, Eva-Maria Sedlmeier, Sandra Steinebrunner
Clinical site, Germany, Dresden: Irena Drozd, Robert Morgenstern, Maike Sigg, Andre Weise
Clinical site, Germany, Munich: Melanie Heinrich, Kerstin Kick, Benjamin Marcus (Klinikum rechts der Isar, Technical University of Munich), Theresa Faure, Melina Kaiser (Helmholtz Munich).
Clinical site, UK, Oxford: Patrick Bose (Royal Berkshire Hospital, Reading), Edel Claire, Eleni Fotaki, Jude Mossop, Dorota Pietrzak, Fenella Roseman (Nuffield Department of Women’s & Reproductive Health, University of Oxford), Yama F Mujadidi, Sophie Vernon, Rachel White (Oxford Vaccine Group, Department of Paediatrics, University of Oxford), Aparna Reddy (Stoke Mandeville Hospital, Aylesbury).
Medical Monitor: Katharina Warncke (Technical University of Munich, Department of Pediatrics, Kinderklinik München Schwabing)
Data Safety and Monitoring Board: Polly Bingley (University of Bristol, Bristol, UK), Ulrich Heininger (University of Basel Children’s Hospital, Basel, Switzerland), Markus Pfirrmann (Ludwig-Maximilians-Universität, Munich, Germany), Wolfgang Rascher (Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany), Paul Turner (University of Oxford, Oxford, UK).
Islet Autoantibody and Confirmatory Laboratory: Institute of Diabetes Research, Helmholtz Munich, Neuherberg, Germany; Bristol Medical School, University of Bristol, Bristol, UK, (Kathleen Gillespie, Kyla Chandler).
Genotyping Laboratory: LGC Genomics Limited, Hoddesdon, Hertfordshire, UK.
Data Management: PHARMALOG, GmbH, Ismaning, Germany.
Pharmacovigilance: Dr. Nibler & Partner, Munich, Germany.
Randomization and Study Product Logistics: GxP Brain GmbH, Berlin, Germany.
Insulin Crystal Supply: Eli Lilly Product Research and Development (PR&D), Eli Lilly Indianapolis, USA.
IMP Supply: Allphamed Pharbil Arzneimittel GmbH, Göttingen, Germany.
Biorepository: Integrated BioBank of Luxembourg (IBBL), Dudelange, Luxembourg.
Funding
The GPPAD studies were supported by The Leona M. and Harry B. Helmsley Charitable Trust grants (#2018PG-T1D022: The Global Platform for Prevention of Autoimmune Diabetes (GPPAD)-02 study and GPPAD coordinating center; #2018PG-T1D023: GPPAD-03 study – POInT; #2018PG-T1D062: Biobanking for POInT). The GPPAD Coordination Center at Helmholtz Munich, Germany, was also supported by internal funding from Helmholtz Munich; the Bavarian Ministry of Economic Affairs, Energy, and Technology (Prevention of Autoimmune Diabetes – Digital Lab), German Federal Ministry of Education and Research (BMBF, FKZ: 01KX1818), German Center for Diabetes Research (DZD e.V.); and an EASD-Novo Nordisk Foundation Diabetes Prize for Excellence (NNF22SA0081044). The Malmö clinical site was also supported by the Swedish Diabetes Foundation, and the Oxford clinical site was also supported by Wellcome (107212/Z/15/Z), JDRF (5-SRA-2015-130-A-N) and the 2021 EASD-Novo Nordisk Foundation Diabetes Prize for Excellence.