Considerations for more actionable consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes. Reply to Mallone R [letter]

Moshe Phillip^{1

2}, Peter Achenbach^{3

4}, Ananta Addala^{5

6}, Anastasia Albanese-O'Neill⁷, Tadej Battelino^{8

9}, Kirstine J Bell¹⁰, Rachel E J Besser^{11

12}, Ezio Bonifacio^{13

14}, Helen M Colhoun^{15

16}, Jennifer J Couper^{17

18

19}, Maria E Craig^{10

20}, Thomas Danne^{21

22}, Carine de Beaufort^{23

24

25}, Klemen Dovc^{8

9}, Sanjoy Dutta²², Osagie Ebekozien²⁶, Helena Elding Larsson^{27

28}, Brigitte I Frohnert²⁹, Mary P Gallagher³⁰, Carla J Greenbaum³¹, Kurt J Griffin^{32

33}, William Hagopian³⁴, Michael J Haller^{35

36}, Emile Hendriks³⁷, Richard I G Holt^{38

39}, Heba M Ismail⁴⁰, Laura M Jacobsen³⁶, Leslie E Kolb⁴¹, Olga Kordonouri²¹, Karin Lange⁴², Robert W Lash⁴³, Åke Lernmark²⁷, Ingrid Libman⁴⁴, Markus Lundgren^{27

45}, David M Maahs⁵, M Loredana Marcovecchio^{37

46}, Chantal Mathieu⁴⁷, Tal Oron^{1

2}, Shivajirao P Patil⁴⁸, Marian J Rewers²⁹, Stephen S Rich⁴⁹, Desmond A Schatz³⁵, Rifka Schulman-Rosenbaum⁵⁰, Kimber M Simmons²⁹, Emily K Sims^{40

51}, Jay S Skyler⁵², Cate Speake³¹, Andrea K Steck²⁹, Ksenia N Tonyushkina⁵³, Riitta Veijola⁵⁴, John M Wentworth^{55

56}, Diane K Wherrett⁵⁷, Jamie R Wood⁵⁸, Anette-Gabriele Ziegler³, Linda A DiMeglio⁴⁰

Affiliations

¹ The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
² Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.
³ Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany.
⁴ Forschergruppe Diabetes, Technical University Munich, Klinikum Rechts Der Isar, Munich, Germany.
⁵ Division of Pediatric Endocrinology, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.
⁶ Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford, CA, USA.
⁷ Breakthrough T1D (formerly known as JDRF), Gainesville, FL, USA. aaoneill@breakthrought1d.org.
⁸ Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
⁹ University Medical Centre Ljubljana, Ljubljana, Slovenia.
¹⁰ Charles Perkins Centre and Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
¹¹ Breakthrough T1D (formerly known as JDRF)/Wellcome Diabetes and Inflammation Laboratory, Wellcome Centre Human Genetics, Nuffield Department of Medicine Oxford NIHR Biomedical Research Centre, University of Oxford, Oxford, UK.
¹² Oxford Children's Hospital, University of Oxford, Oxford, UK.
¹³ Center for Regenerative Therapies Dresden, Faculty of Medicine, Technical University of Dresden, Dresden, Germany.
¹⁴ Paul Langerhans Institute Dresden, Helmholtz Centre Munich at the University Clinic Carl Gustav Carus of TU Dresden and Faculty of Medicine, Dresden, Germany.
¹⁵ The Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK.
¹⁶ Department of Public Health, NHS Fife, Kirkcaldy, UK.
¹⁷ Robinson Research Institute, The University of Adelaide, Adelaide, SA, Australia.
¹⁸ Adelaide Medical School, The University of Adelaide, Adelaide, SA, Australia.
¹⁹ Endocrinology and Diabetes Department, Women's and Children's Hospital, Adelaide, SA, Australia.
²⁰ Discipline of Paediatrics & Child Health, School of Clinical Medicine, UNSW Medicine & Health, Sydney, NSW, Australia.
²¹ NOVA Medical School, Lisbon, Portugal.
²² Breakthrough T1D (formerly known as JDRF), New York, NY, USA.
²³ International Society for Pediatric and Adolescent Diabetes (ISPAD), Berlin, Germany.
²⁴ Pediatric Clinic/Centre Hospitalier de Luxembourg, Luxembourg City, Luxembourg.
²⁵ Faculty of Science, Technology and Medicine, University of Luxembourg, Esch-Belval, Luxembourg.
²⁶ T1D Exchange, Boston, MA, USA.
²⁷ Department of Clinical Sciences Malmö, Lund University CRC, Malmö, Sweden.
²⁸ Department of Pediatrics, Skåne University Hospital, Malmö, Lund, Sweden.
²⁹ Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
³⁰ Department of Pediatrics, Division of Pediatric Endocrinology, NYU Grossman School of Medicine, Hassenfeld Children's Hospital at NYU Langone Health, New York, NY, USA.
³¹ Center for Interventional Immunology and Diabetes Program, Benaroya Research Institute, Seattle, WA, USA.
³² Sanford Research, Sioux Falls, SD, USA.
³³ Department of Pediatrics, Sanford School of Medicine, University of South Dakota, Sioux Falls, SD, USA.
³⁴ Pacific Northwest Diabetes Research Institute, University of Washington, Seattle, WA, USA.
³⁵ Department of Pediatrics, University of Florida Diabetes Institute, Gainesville, FL, USA.
³⁶ Division of Endocrinology, University of Florida College of Medicine, Gainesville, FL, USA.
³⁷ Department of Paediatrics, University of Cambridge and Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
³⁸ Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
³⁹ Southampton National Institute for Health Research Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
⁴⁰ Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.
⁴¹ Association of Diabetes Care & Education Specialists, Chicago, IL, USA.
⁴² Medical Psychology, Hannover Medical School, Hannover, Germany.
⁴³ Endocrine Society, Washington, DC, USA.
⁴⁴ Division of Pediatric Endocrinology and Diabetes, University of Pittsburgh, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.
⁴⁵ Department of Pediatrics, Kristianstad Hospital, Kristianstad, Sweden.
⁴⁶ Department of Paediatric Diabetes and Endocrinology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
⁴⁷ Department of Endocrinology, University Hospitals Gasthuisberg Leuven, Leuven, Belgium.
⁴⁸ Department of Family Medicine, Brody School of Medicine, East Carolina University, Greenville, NC, USA.
⁴⁹ Center for Public Health Genomics, University of Virginia, Charlottesville, VA, USA.
⁵⁰ Division of Endocrinology, Long Island Jewish Medical Center, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, NY, USA.
⁵¹ Division of Pediatric Endocrinology and Diabetology, Herman B Wells Center for Pediatric Research, Center for Diabetes and Metabolic Diseases, Indiana University School of Medicine, Indianapolis, IN, USA.
⁵² Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL, USA.
⁵³ Division of Endocrinology and Diabetes, Baystate Children's Hospital and University of Massachusetts Chan Medical School - Baystate, Springfield, MA, USA.
⁵⁴ Research Unit of Clinical Medicine, Department of Pediatrics, Medical Research Center, Oulu University Hospital and University of Oulu, Oulu, Finland.
⁵⁵ The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia.
⁵⁶ Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville, VIC, Australia.
⁵⁷ Paediatric Endocrinology, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
⁵⁸ Department of Pediatric Endocrinology, University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.

PMID: 39934371
DOI: 10.1007/s00125-024-06350-x

Considerations for more actionable consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes. Reply to Mallone R [letter]

Moshe Phillip et al. Diabetologia. 2025 Apr.

. 2025 Apr;68(4):892-895.

doi: 10.1007/s00125-024-06350-x. Epub 2025 Feb 12.

Authors

Affiliations

¹ The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
² Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.
³ Institute of Diabetes Research, Helmholtz Zentrum München, German Research Center for Environmental Health, Munich-Neuherberg, Germany.
⁴ Forschergruppe Diabetes, Technical University Munich, Klinikum Rechts Der Isar, Munich, Germany.
⁵ Division of Pediatric Endocrinology, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.
⁶ Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford, CA, USA.
⁷ Breakthrough T1D (formerly known as JDRF), Gainesville, FL, USA. aaoneill@breakthrought1d.org.
⁸ Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
⁹ University Medical Centre Ljubljana, Ljubljana, Slovenia.
¹⁰ Charles Perkins Centre and Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
¹¹ Breakthrough T1D (formerly known as JDRF)/Wellcome Diabetes and Inflammation Laboratory, Wellcome Centre Human Genetics, Nuffield Department of Medicine Oxford NIHR Biomedical Research Centre, University of Oxford, Oxford, UK.
¹² Oxford Children's Hospital, University of Oxford, Oxford, UK.
¹³ Center for Regenerative Therapies Dresden, Faculty of Medicine, Technical University of Dresden, Dresden, Germany.
¹⁴ Paul Langerhans Institute Dresden, Helmholtz Centre Munich at the University Clinic Carl Gustav Carus of TU Dresden and Faculty of Medicine, Dresden, Germany.
¹⁵ The Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK.
¹⁶ Department of Public Health, NHS Fife, Kirkcaldy, UK.
¹⁷ Robinson Research Institute, The University of Adelaide, Adelaide, SA, Australia.
¹⁸ Adelaide Medical School, The University of Adelaide, Adelaide, SA, Australia.
¹⁹ Endocrinology and Diabetes Department, Women's and Children's Hospital, Adelaide, SA, Australia.
²⁰ Discipline of Paediatrics & Child Health, School of Clinical Medicine, UNSW Medicine & Health, Sydney, NSW, Australia.
²¹ NOVA Medical School, Lisbon, Portugal.
²² Breakthrough T1D (formerly known as JDRF), New York, NY, USA.
²³ International Society for Pediatric and Adolescent Diabetes (ISPAD), Berlin, Germany.
²⁴ Pediatric Clinic/Centre Hospitalier de Luxembourg, Luxembourg City, Luxembourg.
²⁵ Faculty of Science, Technology and Medicine, University of Luxembourg, Esch-Belval, Luxembourg.
²⁶ T1D Exchange, Boston, MA, USA.
²⁷ Department of Clinical Sciences Malmö, Lund University CRC, Malmö, Sweden.
²⁸ Department of Pediatrics, Skåne University Hospital, Malmö, Lund, Sweden.
²⁹ Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
³⁰ Department of Pediatrics, Division of Pediatric Endocrinology, NYU Grossman School of Medicine, Hassenfeld Children's Hospital at NYU Langone Health, New York, NY, USA.
³¹ Center for Interventional Immunology and Diabetes Program, Benaroya Research Institute, Seattle, WA, USA.
³² Sanford Research, Sioux Falls, SD, USA.
³³ Department of Pediatrics, Sanford School of Medicine, University of South Dakota, Sioux Falls, SD, USA.
³⁴ Pacific Northwest Diabetes Research Institute, University of Washington, Seattle, WA, USA.
³⁵ Department of Pediatrics, University of Florida Diabetes Institute, Gainesville, FL, USA.
³⁶ Division of Endocrinology, University of Florida College of Medicine, Gainesville, FL, USA.
³⁷ Department of Paediatrics, University of Cambridge and Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
³⁸ Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
³⁹ Southampton National Institute for Health Research Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
⁴⁰ Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.
⁴¹ Association of Diabetes Care & Education Specialists, Chicago, IL, USA.
⁴² Medical Psychology, Hannover Medical School, Hannover, Germany.
⁴³ Endocrine Society, Washington, DC, USA.
⁴⁴ Division of Pediatric Endocrinology and Diabetes, University of Pittsburgh, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.
⁴⁵ Department of Pediatrics, Kristianstad Hospital, Kristianstad, Sweden.
⁴⁶ Department of Paediatric Diabetes and Endocrinology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
⁴⁷ Department of Endocrinology, University Hospitals Gasthuisberg Leuven, Leuven, Belgium.
⁴⁸ Department of Family Medicine, Brody School of Medicine, East Carolina University, Greenville, NC, USA.
⁴⁹ Center for Public Health Genomics, University of Virginia, Charlottesville, VA, USA.
⁵⁰ Division of Endocrinology, Long Island Jewish Medical Center, Northwell Health, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, NY, USA.
⁵¹ Division of Pediatric Endocrinology and Diabetology, Herman B Wells Center for Pediatric Research, Center for Diabetes and Metabolic Diseases, Indiana University School of Medicine, Indianapolis, IN, USA.
⁵² Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, FL, USA.
⁵³ Division of Endocrinology and Diabetes, Baystate Children's Hospital and University of Massachusetts Chan Medical School - Baystate, Springfield, MA, USA.
⁵⁴ Research Unit of Clinical Medicine, Department of Pediatrics, Medical Research Center, Oulu University Hospital and University of Oulu, Oulu, Finland.
⁵⁵ The Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, Australia.
⁵⁶ Department of Diabetes and Endocrinology, Royal Melbourne Hospital, Parkville, VIC, Australia.
⁵⁷ Paediatric Endocrinology, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
⁵⁸ Department of Pediatric Endocrinology, University Hospitals Cleveland Medical Center, Rainbow Babies and Children's Hospital, Cleveland, Ohio, USA.

PMID: 39934371
DOI: 10.1007/s00125-024-06350-x

No abstract available

Keywords: Autoantibodies; Glucose monitoring; Prevention; Type 1 diabetes.

PubMed Disclaimer

Conflict of interest statement

Authors’ relationships and activities: MP has received honoraria for participation on advisory boards for AstraZeneca, Eli Lilly, MannKind, Medtronic Diabetes, Pfizer, Sanofi, Dompé, LifeScan, Novo Nordisk, Insulet, Provention Bio, Merck, Ascensia, Bayer, Embecta and Tandem, and as a speaker for Eli Lilly, Medtronic Diabetes, Novo Nordisk, Pfizer, Sanofi and Ascensia. MP owns stocks in DreaMed Diabetes and NG Solutions and his institution has received research grant support from Eli Lilly, Medtronic Diabetes, Novo Nordisk, Pfizer, Sanofi, DreaMed Diabetes, NG Solutions, Dompé, Lumos, GWave, OPKO, Provention Bio, AstraZeneca and Omega Galil, and consulting fees from Qulab Medical and Provention Bio. TB has served on advisory boards of Novo Nordisk, Sanofi, Eli Lilly, Boehringer Ingelheim, Medtronic, Abbott and Indigo Diabetes. TB has received honoraria for participating on the speakers bureau of Eli Lilly, Novo Nordisk, Medtronic, Abbott, Sanofi, Dexcom, Aventis, Astra Zeneca and Roche. TB’s institution has received research grant support from Abbott, Medtronic, Novo Nordisk, Sanofi, Novartis, Sandoz, Zealand Pharma, the Slovenian Research and Innovation Agency, the National Institutes of Health and the European Union. REJB is a member of the Provention Bio advisory board and has received a speaker’s honorarium from EASD Rising Stars sponsored by Sanofi and a Superior Novo Nordisk PHD Fellowship. EB has received speaker’s honoraria from Sanofi. HMC has received research grant support from Sanofi, IQVIA, Breakthrough T1D (formerly known as JDRF), Chief Scientist Office, Diabetes UK and the UK Medical Research Council. HMC has received honorarium from Novo Nordisk and owns shares in Roche Pharmaceuticals and Bayer AG. TD has received lecture/other fees and honoraria from Abbott, Astra Zeneca, Boehringer Ingelheim, Dexcom, Eli Lilly, Medtronic, Novo Nordisk, Provention Bio, Roche, Sanofi and Vertex. KD has received honoraria for participation on advisory boards for Medtronic and Novo Nordisk and speaker fees from Abbott, Eli Lilly, Novo Nordisk, Medtronic and Pfizer. OE is a member of the Sanofi and Medtronic Diabetes advisory boards. OE has received research support from Medtronic Diabetes, MannKind Pharmaceutical, Dexcom, Eli Lilly Diabetes, Abbott, Vertex Pharmaceutical and Janssen Pharmaceutical. OE has received consulting and speaker fees from Medtronic Diabetes, Sanofi and Vertex. All financial support from industry for OE has been through his organisation, T1D Exchange. RIGH has received honoraria for speaking from EASD, Eli Lilly, ENCORE, Liberum, Novo Nordisk, Rovi and Boehringer Ingelheim. RIGH has received conference funding from Novo Nordisk and Eli Lilly. OK has received honorarium and lecture fees from the Sanofi advisory board. DMM has received research support from the NIH, Breakthrough T1D (formerly known as JDRF), NSF and Helmsley Charitable Trust and his institution has had research support from Medtronic, Dexcom, Insulet, Bigfoot Biomedical, Tandem and Roche. RWL has received a consultancy fee from Cigna Insurance. AL has received honorarium from Diamyd Medical AB. MJR has received employment/consultancy fees or grants from Sanofi, Provention Bio and Janssen R&D. KMS has received consultancy fees, grants or honorarium from Provention Bio and Sanofi. KMS has been an advisory board member and consultant for Sanofi, received research funding from Protect. EKS has received lecture fees from Medscape, ADA, Health Matters CME and Med Learning Group LLC and employment/consultancy fees from Sanofi and DRI Healthcare. JSS has been a scientific advisory board member for 4Immune, Abvance, ActoBiotics, Avotres, Biomea Fusion, Kriya Therapeutics, Levicure and Quell Therapeutics. JSS has been a data safety board member for Imcyse and Provention Bio and is a board of directors member for Applied Therapeutics and SAB Therapeutics. JSS has been an advisor or consultant for Dexcom, Eli Lilly, Immunomolecular Therapeutics, Novo Nordisk, Remedy Plan Inc, SAB Therapeutics, Sanofi and Shoreline Therapeutics. JSS has shares in or is an option holder for 4Immune, Abvance, Applied Therapeutics, Avotres, Dexcom, Immunomolecular Therapeutics, Levicure, Remedy Plan Inc and SAB Therapeutics. LAD has received research support for their institution from Dompé, Lilly, MannKind, Medtronic, Provention/Sanofi and Zealand and consulting fees from Vertex and Abata. LAD has a patent pending for use of difuoromethylornithine (DFMO). All other authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work. Contribution statement: All coauthors on the original manuscript were given the opportunity to contribute to this response letter. All listed authors were responsible for drafting and reviewing this letter of response. All listed authors approved the final version of the letter submitted for publication.

References

1. Mallone R (2024) Considerations for more actionable consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes. Diabetologia. https://doi.org/10.1007/s00125-024-06296-0 - DOI - PubMed
1. Phillip M, Achenbach P, Addala A et al (2024) Consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes. Diabetologia 67:1731–1759. https://doi.org/10.1007/s00125-024-06205-5 - DOI - PubMed - PMC
1. Marzinotto I, Pittman DL, Williams AJK et al (2023) Islet Autoantibody Standardization Program: interlaboratory comparison of insulin autoantibody assay performance in 2018 and 2020 workshops. Diabetologia 66(5):897–912. https://doi.org/10.1007/s00125-023-05877-9 - DOI - PubMed - PMC
1. US Food and Drug Administration (2023) Clinical Laboratory Improvement Amendments (CLIA). Available from https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-l... . Accessed 3 Dec 2024
1. Bediaga NG, Li-Wai-Suen CSN, Haller MJ et al (2021) Simplifying prediction of disease progression in pre-symptomatic type 1 diabetes using a single blood sample. Diabetologia 64(11):2432–2444. https://doi.org/10.1007/s00125-021-05523-2 - DOI - PubMed - PMC

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Considerations for more actionable consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes. Reply to Mallone R [letter]

Affiliations

Considerations for more actionable consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes. Reply to Mallone R [letter]

Authors

Affiliations

Conflict of interest statement

References

Publication types

LinkOut - more resources

Full Text Sources