Introducing the Endotype Concept to Address the Challenge of Disease Heterogeneity in Type 1 Diabetes
Open accessAbstract
The clinical diagnosis of new-onset type 1 diabetes has, for many years, been considered relatively straightforward. Recently, however, there is increasing awareness that within this single clinical phenotype exists considerable heterogeneity: disease onset spans the complete age range; genetic susceptibility is complex; rates of progression differ markedly, as does insulin secretory capacity; and complication rates, glycemic control, and therapeutic intervention efficacy vary widely. Mechanistic and immunopathological studies typically show considerable patchiness across subjects, undermining conclusions regarding disease pathways. Without better understanding, type 1 diabetes heterogeneity represents a major barrier both to deciphering pathogenesis and to the translational effort of designing, conducting, and interpreting clinical trials of disease-modifying agents. This realization comes during a period of unprecedented change in clinical medicine, with increasing emphasis on greater individualization and precision. For complex disorders such as type 1 diabetes, the option of maintaining the “single disease” approach appears untenable, as does the notion of individualizing each single patient’s care, obliging us to conceptualize type 1 diabetes less in terms of phenotypes (observable characteristics) and more in terms of disease endotypes (underlying biological mechanisms). Here, we provide our view on an approach to dissect heterogeneity in type 1 diabetes. Using lessons from other diseases and the data gathered to date, we aim to delineate a roadmap through which the field can incorporate the endotype concept into laboratory and clinical practice. We predict that such an effort will accelerate the implementation of precision medicine and has the potential for impact on our approach to translational research, trial design, and clinical management.
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Contemporary and large natural history studies have shown that type 1 diabetes is a heterogeneous disorder and that features beyond autoimmunity, including metabolic factors, exocrine function and environmental exposures, impact progression to clinical disease.
“Contemporary and large natural history studies assembled based on HLA genotypes and family history have shown that type 1 diabetes is a heterogenous disorder and that features beyond autoimmunity, including metabolic factors, exocrine function and environmental exposures, impact progression to clinical disease61.”
From 100 years of insulin: celebrating the past, present and future of diabetes therapy (2021) · cites this paper as [61]
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Self-citation
- Authors
- Battaglia, M., Ahmed, S., Anderson, M. S., Atkinson, M. A., Becker, D., Bingley, P. J., Bosi, E., Brusko, T. M., DiMeglio, L. A., Evans-Molina, C., Gitelman, S. E., Greenbaum, C. J., Gottlieb, P. A., Herold, K. C., Hessner, M. J., Knip, M., Jacobsen, L., Krischer, J. P., Long, S. A., Lundgren, M., McKinney, E. F., Morgan, N. G., Oram, R. A., Pastinen, T., Peters, M. C., Petrelli, A., Qian, X., Redondo, M. J., Roep, B. O., Schatz, D., Skibinski, D., & Peakman, M.
- Affiliations
- IRCCS Ospedale San Raffaele (IT)
- Breakthrough T1D (US)
- University of California, San Francisco (US)
- University of Florida Health (US)
- Children's Hospital of Pittsburgh (US)
- University of Bristol (GB)
- Vita-Salute San Raffaele University (IT)
- Indiana University Indianapolis (US)
- Herman B Wells Center for Pediatric Research, Indiana University School of Medicine, Indianapolis, IN
- Benaroya Research Institute (US)
- University of Colorado Anschutz (US)
- Yale University (US)
- Medical College of Wisconsin (US)
- University of Helsinki (FI)
- University of South Florida (US)
- Lund University (SE)
- University of Cambridge (GB)
- University of Exeter (GB)
- Children's Mercy Hospital (US)
- Texas A&M University System (US)
- Baylor College of Medicine (US)
- City Of Hope National Medical Center (US)
- King's College London (GB)
- Corresponding author
- Battaglia, Manuela
- Peakman, Mark
- ORCID
- Battaglia, Manuela
- Anderson, Mark S.
- Atkinson, Mark A.
- Becker, Dorothy
- Bosi, Emanuele
- Brusko, Todd M.
- DiMeglio, Linda A.
- Evans-Molina, Carmella
- Gitelman, Stephen E.
- Greenbaum, Carla J.
- Gottlieb, Peter A.
- Herold, Kevan C.
- Hessner, Martin J.
- Knip, Mikael
- Jacobsen, Laura
- Krischer, Jeffrey P.
- Long, S. Alice
- Lundgren, Markus
- McKinney, Eoin F.
- Morgan, Noel G.
- Oram, Richard A.
- Pastinen, Tomi
- Peters, Michael C.
- Petrelli, Alessandra
- Qian, Xiaoning
- Redondo, Maria J.
- Roep, Bart O.
- Schatz, Desmond
- Skibinski, David
- Peakman, Mark
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2019-12-12
- Volume
- 43
- Issue
- 1
- Pages
- 5-12
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC6925574
- OpenAlex
- W2991077754
- Cited by
- 351
- References
- 7
- Citations by year
- 2026: 31 · 2025: 52 · 2024: 48 · 2023: 61 · 2022: 57 · 2021: 69 · 2020: 32 · 2018: 1
- FWCI
- 23.81
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
- Research Portal (King's College London) (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- Royal Devon and Exeter Research Repository (Royal Devon and Exeter) (submittedVersion)
- Bristol Research (University of Bristol) (submittedVersion)
- IUScholarWorks (Indiana University) (submittedVersion)
- Purdue University Indianapolis (Indiana University) (submittedVersion)
- Funders
- U.S. Department of Veterans Affairs (I01-BX001733)
- Leona M. and Harry B. Helmsley Charitable Trust
- University of South Florida
- Wellcome Trust (104064/Z/14/Z)
- University of Oxford
- Novo Nordisk Fonden (NNF19OC0056748)
- National Institutes of Health (UL1TR001863)
- Medical Research Council (MC_PC_15047)
- National Institute of Allergy and Infectious Diseases (P01AI042288)
- National Institute of Diabetes and Digestive and Kidney Diseases (U01DK103153, U01DK061010, U01DK103180, P30DK097512, P30DK045735)
- National Center for Advancing Translational Sciences
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Surgery › Pancreatic function and diabetes
- Keywords
- type 1 diabetes, disease endotypes, disease heterogeneity, precision medicine, disease-modifying therapy, clinical trial design, pathogenesis, insulin secretion, disease progression, genetic susceptibility
- MeSH terms
- Biological Variation, Population, Blood Glucose, Diabetes Mellitus, Type 1, Humans, Insulin, Phenotype, Disease Progression, Precision Medicine
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