GPPAD Study Group

GPPAD Study Group
GPPAD-Coordinating Center (CC)
Peter Achenbach ^1,2,3, Stefanie Arnolds ¹, Karina Blasius¹, Ezio Bonifacio^2,4,5,6, Michaela Dilong¹, Veronika Fendt¹, Melanie Gündert ¹, Florian Haupt¹, Martin Heigermoser¹, Elisabeth Huber¹, Sandra Hummel¹, Nadine Klein¹, Ramona Lickert¹, Claudia Matzke¹, Lorena Müller¹, Rebecca Niewöhner¹, Cigdem Sanverdi¹, Marlon Scholz¹, Katharina Schütte-Borkovec¹, Merve Vurucu ¹, Anette-Gabriele Ziegler ^1,2,3

Statistical Analysis Team
Thomas Lang⁷, Markus Pfirrmann⁷, Andreas Weiß¹, José Maria Zapardiel Gonzalo¹

Screnning for Risk (GPPAD-02)
Belgium, Flanders
Kristina Casteels^8,9, Janne Houben^8,10, An Jacobs⁸, Charlien Jannsen¹¹, Hilde Morobé¹¹, Jasmin Paulus¹¹, Anne Rochtus⁸, Natalie Van den Driessche¹¹, Renka Van Heyste¹¹, Veerle Vanhuyse¹², Brontë Vrancken¹¹
Germany, Saxony
Lisa Barbknecht⁴, Ezio Bonifacio^2,4,5,6, Uta Ceglarec¹³, Franziska Ehrlich⁴, Gita Gemulla^{4, 14}, Angela Hommel⁴, Anja Loff⁴, Peter Mirtschink¹⁵, Anne Schille⁴, Pauline Wimberger¹⁶, Nicole Zubizarreta⁴
Germany, Lower Saxony
Frank Roloff¹⁷
Germany, Bavaria
Stefanie Jacobson¹, Manja Jolink¹, Kerstin Kick^1, Christiane Winkler ¹
Poland, Voivodship Mazowieckie
Marta Krysicka¹⁸, Mariusz Ołtarzewski^18,19, Agnieszka Szypowska^18,19
Sweden, Skåne Region
Sofie Alström Mortin²⁰, Helena Elding Larsson^20,21, Maria Hyllengren²⁰, Ida Jönsson²⁰,
Emma Karlsson^20,21, Dorota Lacki^20,21, Markus Lundgren^20,22, Hannah Nenonen^20,21, Hanna Samuelsson^20,21
United Kingdom, Oxford Region
Ian Smith²³, Nazia Taj²³, John A Todd²⁴, Manu Vatish²⁵, Tabitha Wishlade²⁵

POInT Clinical Trial (GPPAD-03)
Belgium, Leuven
Kristina Casteels^8,9, Janne Houben^8,10, An Jacobs⁸, Charlien Jannsen¹¹, Hilde Morobé¹¹, Jasmin Paulus¹¹, Anne Rochtus⁸, Natalie Van den Driessche¹¹, Renka Van Heyste¹¹, Veerle Vanhuyse¹², Brontë Vrancken¹¹
Germany, Dresden
Reinhard Berner¹⁴, Ezio Bonifacio^2,4,5,6, Sevina Dietz⁴, Irena Drozd⁴, Franziska Ehrlich⁴, Gita Gemulla^4,14, Angela Hommel⁴, Franziska Lange¹⁴, Anja Loff⁴, Katja Steinberg-Bains⁴, Dana Thetmeyer⁴, Marc Weigelt⁴, Nicole Zubizarreta⁴
Germany, Hanover
Olga Kordonouri¹⁷, Carolin Kruse¹⁷, Sarah Landsberg¹⁷, Erika Marquardt¹⁷, Mareike Niemeyer¹⁷, Felix Reschke¹⁷, Frank Roloff¹⁷, Bianca Schmidt¹⁷, Thekla von dem Berge¹⁷, Jantje Weiskorn¹⁷
Germany, Munich
Peter Achenbach ^1,2,3, elanie Bunk ¹, Willi Grätz¹, Anna Hofelich ¹, Annette Knopff ¹, Annette Munzinger ¹, Franziska Reinmüller ¹, Katharina Sarcletti ¹
Poland, Warsaw
Adrianna Cieloch¹⁸, Wiktoria Czerwińska¹⁸, Sylwia Dybkowska¹⁸, Natalia Dziedzic¹⁸, Elżbieta Górska¹⁸, Lidia Groele¹⁸, Agnieszka Mroczek¹⁸, Dorota Owczarek¹⁸, Katarzyna Popko¹⁸, Agnieszka Szypowska^18,19, Beata Zduńczyk¹⁸, Anna Zych¹⁸
Sweden, Malmö
Sofie Alström Mortin²⁰, Helena Elding Larsson^20,21, Lina Fransson^20,21, Malin Goldman-Tsubarah^20,21, Markus Lundgren^20,22, Jessica Melin^20,21, Hannah Nenonen^20,21, Kobra Rhamati^20,21, Falastin Salami^20,21, Carina Törn²⁶
United Kingdom, Oxford
Owen Bendor-Samuel²⁷, Rachel E J Besser^28,29,30, Rachel Craik²⁷, Sophia Hawkins^.31,32, Alice Lelliott^31,32, Helen Ratcliffe^31,32, Matthew Snape²⁹, Sophie Vernon^31,32, Connor Whelan^31,32, Louise Willis²⁷

Acknowledgement
We sincerely thank the participating families for their contribution to type 1 diabetes research and their support in advancing therapies for prevention.
We also highly acknowledge the following support:
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:
Donation from Eli Lilly Product Research and Development (PR&D), Eli Lilly Indianapolis Active
Pharmaceutical Ingredient (IAPI), Indianapolis, USA
IMP Supply:
Allphamed Pharbil Arzneimittel GmbH, Göttingen, Germany
Biorepository:
Integrated BioBank of Luxembourg (IBBL), Dudelange, Luxembourg

Funding
The GPPAD studies are supported by multiple grants and funding sources:

– The Leona M. and Harry B. Helmsley Charitable Trust (Helmsley) grants

• #2018PG-T1D022: The Global Platform for Prevention of Autoimmune Diabetes (GPPAD)-02 study and GPPAD coordinating center
• #2018PG-T1D023: GPPAD-03 study – POInT (Primary Oral Insulin Trial)
• #2018PG-T1D062: Biobanking for the Primary Oral Insulin Trial

– Helmholtz Munich, German Research Center for Environmental Health, Germany

– Bavarian Ministry of Economic Affairs, Energy, and Technology (grant: Prevention of Autoimmune Diabetes – Digital Lab)

– German Federal Ministry of Education and Research (BMBF):

• grant FKZ: 01KX1818
• German Center for Diabetes Research (DZD e.V.)

– Munich, Germany: EASD-Novo Nordisk Foundation Diabetes Prize for Excellence (NNF22SA0081044)

– Malmö, Sweden: Swedish Diabetes Foundation

– Oxford, United Kingdom: Wellcome [107212/Z/15/Z] and JDRF [5-SRA-2015-130-A-N]

Patent
The authors AGZ, EB, and PA are inventors of a patent entitled “Method for determining the risk to develop type 1 diabetes” (WO 2019/002364).

1 Institute of Diabetes Research, Helmholtz Munich, German Research Center for Environmental Health, Neuherberg, Germany
2 German Center for Diabetes Research (DZD e.V.), Neuherberg, Germany
3 Forschergruppe Diabetes, School of Medicine, Klinikum rechts der Isar, Technical University Munich, Munich, Germany
4 Center for Regenerative Therapies Dresden, Technische Universität Dresden, Dresden, Germany
5 Paul Langerhans Institute Dresden of the 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 The Institute for Medical Information Processing, Biometry, and Epidemiology (IBE), 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 Liaison Psychology Pediatrics, UZ Leuven, Leuven, Belgium
11 Research & Development Endocrinology, University Hospital Gasthuisberg, Leuven, Belgium
12 Clinical & Experimental Endocrinology, KU Leuven, Leuven, Belgium
13 Department of Medicine, University of Leipzig, Leipzig, Germany
14 Department of Pediatrics, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
15 Institute for Clinical Chemistry and Laboratory Medicine, Faculty of Medicine, Technische Universität Dresden, Dresden, Germany
16 Department of Obstetrics and Gynecology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
17 Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany
18 Department of Paediatric Diabetology and Paediatrics, The Children’s Clinical Hospital Józef Polikarp Brudziński, Warsaw, Poland
19 Department of 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 Screening Laboratory, Department of Clinical Biochemistry, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
24 Diabetes and Inflammation Laboratory, Centre for Human Genetics, Nuffield Department of Medicine, NIHR Oxford Biomedical Research Centres, University of Oxford, Oxford, UK
25 Nuffield Department of Obstetrics and Gynaecology, University of Oxford, John Radcliffe Hospital, Oxford, UK
26 Unit for Celiac and Diabetes, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden
27 Oxford Vaccine Group, University of Oxford, Oxford, UK
28 Centre for Human Genetics, Nuffield Department of Medicine, National Institute for Health and Care Research Oxford Biomedical Research Centre, University of Oxford UK
29 Department of Paediatrics, 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
31 Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK
32 NIHR Oxford Biomedical Research Centre, Oxford, UK

Study Group

GPPAD-Coordinating Center (CC, 02)
Melanie Gündert, Stefanie Arnolds, Karina Blasius, Michaela Dilong, Nadine Friedl, Gertrud
Göppel, Florian Haupt, Luisa Hoffmann, Martin Heigermoser, Maja Hergl, Sandra Hummel, Manja Jolink, Krisztian Kisfügedi, Kristina Korhonova, Nadine Klein, Ramona Lickert Stefanie Löbner, Leonard Nevaril, Rebecca Niewöhner, Katharina Sarcletti, Marlon Scholz, Lena Schwenker, Katharina Schütte-Borkovec, Ricarda Stössel, Andreas Weiß, Christiane Winkler, José Maria Zapardiel Gonzalo, Lorena Müller
Belgium Clinical Center
Kristina Casteels, An Jacobs, Charlien Jannsen, Hilde Morobé, Jasmin Paulus, Anne Rochtus, Natalie Van den Driessche, Renka Van Heyste, Janne Houben, Veerle Vanhuyse, Brontë Vrancken
Germany, Dresden Clinical Center
Ezio Bonifacio, Reinhard Berner, Sari Arabi, Lisa Barbknecht, Uta Ceglarec, Sevina Dietz, Irena Drozd, Franziska Ehrlich, Gita Gemulla, Angela Hommel, Franziska Lange, Anja Loff, Peter Mirtschink, Anne Schille, Marc Weigelt, Pauline Wimberger, Nicole Zubizarreta
Germany, Hanover Clinical Center
Olga Kordonouri, Carolin Kruse, Sarah Landsberg, Karin Lange, Erika Marquardt, Mareike Niemeyer, Felix Reschke, Frank Roloff, Bianca Schmidt, Jantje Weiskorn, Thekla von dem Berge
Germany, Munich Clinical Center
Anette-Gabriele Ziegler, Peter Achenbach, Heidi Eifler, Annika Fehn, Anna Festl, Anna Hofelich, Stefanie Jacobson, Melina Kaiser, Claudia Matzke, Annette Munzinger, Franziska Reinmüller, Thaisa Rodrigues Tagliari, Katharina Sarcletti, Natalie Villalobos Trigueros, Merve Vurucu
Poland Clinical Center
Agnieszka Szypowska, Mariusz Ołtarzewski, Wiktoria Czerwińska, Adrianna Cieloch, Sylwia Dybkowska, Natalia Dziedzic, Elżbieta Górska, Lidia Groele, Agnieszka Mroczek, Dorota Owczarek, Katarzyna Popko, Beata Zduńczyk, Anna Zych
Sweden Clinical Center
Helena Elding Larsson, Markus Lundgren, Daniel Agardh, Sofie Alström Mortin, Rasmus Bennet,
Charlotte Brundin, Lina Fransson, Malin Goldman-Tsubarah, Maria Hyllengren, Ida Jönsson, Emma Karlsson, Marielle Lindström, Jessica Melin, Hannah Nenonen, Anita Ramelius, Kobra Rhamati, Falastin Salami, Hanna Samuelsson, Carina Törn
United Kingdom, Newcastle Clinical Center
Catherine Owen, Stephen Robson, Stephen Crulley, Marc Davies, Andrea Fenn, Helen Gallon, Fiona Jenkinson, Andrew Johnston, Sharon King, Caroline Miller, Fiona Yelnoorkar, Claire Wood

Acknowledgement

We thank participating families for their participation in type 1 diabetes research and for helping to develop therapies for prevention.
We also highly acknowledge the following support:
Data Safety and Monitoring Board:
Polly Bingley (University of Bristol, Bristol, UK), Ulrich Heininger (Division of Paediatric Infectious  Diseases and Vaccinology, University Children’s Hospital, Basel, Switzerland), Markus Pfirrmann (Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Ludwig-Maximilians-Universität, Munich, Germany), Wolfgang Rascher (Department of Pediatrics and Adolescent Medicine, Erlangen, Germany), Paul Turner (Nuffield Department of Medicine, Medical Science Division, Oxford, UK)
Beta-cell Autoantibody and Confirmatory Laboratory:
Institute of Diabetes Research, Helmholtz Munich, Neuherberg, Germany.
Bristol Medical School, The University of Bristol, Bristol, UK.
Genotyping Laboratory: 
Grace London, LGC Ltd., Hertfordshire, UK
Database/ Electronic Questionnaires: 
PHARMALOG, GmbH, Ismaning, Germany
Study Product Supply:
Infinant Health Davis, California, USA
Central Pharmacy:
Pharmacy of the University Hospital of Heidelberg, Germany
Biorepository:
Integrated BioBank of Luxembourg (IBBL), Dudelange, Luxembourg
IVRS:
GxP brain GmbH, Berlin, Germany

Study Group

GPPAD-Coordinating Center (CC, 02)
Melanie Gündert, Stefanie Arnolds, Karina Blasius, Michaela Dilong, Nadine Friedl, Gertrud
Göppel, Florian Haupt, Luisa Hoffmann, Martin Heigermoser, Maja Hergl, Sandra Hummel, Manja Jolink, Krisztian Kisfügedi, Kristina Korhonova, Nadine Klein, Ramona Lickert Stefanie Löbner, Leonard Nevaril, Rebecca Niewöhner, Katharina Sarcletti, Marlon Scholz, Lena Schwenker, Katharina Schütte-Borkovec, Ricarda Stössel, Andreas Weiß, Christiane Winkler, José Maria Zapardiel Gonzalo, Lorena Müller
Belgium Clinical Center
Kristina Casteels, An Jacobs, Charlien Jannsen, Hilde Morobé, Jasmin Paulus, Anne Rochtus, Natalie Van den Driessche, Renka Van Heyste, Janne Houben, Veerle Vanhuyse, Brontë Vrancken
Germany, Dresden Clinical Center
Ezio Bonifacio, Reinhard Berner, Sari Arabi, Lisa Barbknecht, Uta Ceglarec, Sevina Dietz, Irena Drozd, Franziska Ehrlich, Gita Gemulla, Angela Hommel, Franziska Lange, Anja Loff, Peter Mirtschink, Anne Schille, Marc Weigelt, Pauline Wimberger, Nicole Zubizarreta
Germany, Hanover Clinical Center
Olga Kordonouri, Carolin Kruse, Sarah Landsberg, Karin Lange, Erika Marquardt, Mareike Niemeyer, Felix Reschke, Frank Roloff, Bianca Schmidt, Jantje Weiskorn, Thekla von dem Berge
Germany, Munich Clinical Center
Anette-Gabriele Ziegler, Peter Achenbach, elanie Bunk, Anna Festl, Anna Hofelich, Stefanie Jacobson, Melina Kaiser, Alexandra Käßl, Claudia Matzke, Annette Munzinger, Samuel Owoeye, Thaisa Rodrigues Tagliari, Cigdem Sanverdi Katharina Sarcletti, Sarah Schill, Natalie Villalobos Trigueros, Merve Vurucu, Christiane Winkler
Sweden Clinical Center
Helena Elding Larsson, Markus Lundgren, Daniel Agardh, Sofie Alström Mortin, Rasmus Bennet,
Charlotte Brundin, Lina Fransson, Malin Goldman-Tsubarah, Maria Hyllengren, Ida Jönsson, Emma Karlsson, Marielle Lindström, Jessica Melin, Hannah Nenonen, Anita Ramelius, Kobra Rhamati, Falastin Salami, Hanna Samuelsson, Carina Törn
United Kingdom, Newcastle Clinical Center
Catherine Owen, Stephen Robson, Stephen Crulley, Marc Davies, Andrea Fenn, Helen Gallon, Fiona Jenkinson, Andrew Johnston, Sharon King, Caroline Miller, Fiona Yelnoorkar, Claire Wood
United Kingdom, Cambridge Clinical Center
Loredana Marcovecchio, Katarzyna Gajewska-Knapik, Elena Otero Romero, Suzannah Twiss, Ann-Marie Wardell

Acknowledgement

We thank participating families for their participation in type 1 diabetes research and for helping to develop therapies for prevention.
We also highly acknowledge the following support:
Data Safety and Monitoring Board:
Polly Bingley (University of Bristol, Bristol, UK), Ulrich Heininger (Division of Paediatric Infectious Diseases and Vaccinology, University Children’s Hospital, Basel, Switzerland), Markus Pfirrmann (Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Ludwig-Maximilians-Universität, Munich, Germany), Wolfgang Rascher (Department of Pediatrics and Adolescent Medicine, Erlangen, Germany), Paul Turner (Nuffield Department of Medicine, Medical Science Division, Oxford, UK)
Beta-Cell autoantibody laboratory:
Institute of Diabetes Research, Helmholtz Munich, Neuherberg, Germany
Central Laboratories:
– Institute of Diabetes Research, Helmholtz Munich, Neuherberg, Germany
– University Hospital Leipzig, Institute for Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, Leipzig, Germany
– Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland
– King’s College London, London SE1 1UL, UK
– Thermo Fisher Scientific, Freiburg, Germany
Genotyping Laboratory:
Grace London, LGC Ltd., Hertfordshire, UK  
Electronic Questionnaires and Database:
PHARMALOG, GmbH, Ismaning, Germany  
Pharmacovigilance:
Dr. Nibler & Partner, Munich, Germany
IMP Supply:
Paul-Ehrlich-Institute (PEI), Institut: ZEPAI (Zentrum für Pandemie-Impfstoffe und Therapeutika), Langen, Germany
Study Pharmacy:
Pharmacy of the University Hospital of Heidelberg, Germany
Biorepository:
Integrated BioBank of Luxembourg (IBBL), Dudelange, Luxembourg