Staging presymptomatic type 1 diabetes: A scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association

Insel, Richard A.; Dunne, Jessica L.; Atkinson, Mark A.; Chiang, Jane L.; Dabelea, Dana; Gottlieb, Peter A.; Greenbaum, Carla J.; Herold, Kevan C.; Krischer, Jeffrey P.; Lernmark, Åke; Ratner, Robert E.; Rewers, Marian J.; Schatz, Desmond A.; Skyler, Jay S.; Sosenko, Jay M.; Ziegler, Anette-G.

doi:10.2337/dc15-1419

Cited by 1,216Diabetes and associated disordersDiabetes Management and ResearchPancreatic function and diabetes

Staging presymptomatic type 1 diabetes: A scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association

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Insel, Richard A., Dunne, Jessica L., Atkinson, Mark A., Chiang, Jane L., Dabelea, Dana, Gottlieb, Peter A., Greenbaum, Carla J., Herold, Kevan C. +8 more·2015·Diabetes Care

DOI 10.2337/dc15-1419PMC PMC5321245

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Abstract

Insights from prospective, longitudinal studies of individuals at risk for developing type 1 diabetes have demonstrated that the disease is a continuum that progresses sequentially at variable but predictable rates through distinct identifiable stages prior to the onset of symptoms. Stage 1 is defined as the presence of β-cell autoimmunity as evidenced by the presence of two or more islet autoantibodies with normoglycemia and is presymptomatic, stage 2 as the presence of β-cell autoimmunity with dysglycemia and is presymptomatic, and stage 3 as onset of symptomatic disease. Adoption of this staging classification provides a standardized taxonomy for type 1 diabetes and will aid the development of therapies and the design of clinical trials to prevent symptomatic disease, promote precision medicine, and provide a framework for an optimized benefit/risk ratio that will impact regulatory approval, reimbursement, and adoption of interventions in the early stages of type 1 diabetes to prevent symptomatic disease.

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Autoantibody markers plus clinical presentation can help distinguish type 1 from type 2 diabetes in children and adults.
“The presence or absence of autoimmune markers (autoantibodies to glutamic acid decarboxylase [GAD65], pancreatic islet b cells [tyrosine phosphatase IA-2], and IA-2b zinc transporter [ZnT8], and/or insulin) in addition to the clinical presentation may help establish the correct diagnosis to distinguish between T1D and T2D in children or adults.22–27”
From American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. (2022) · cites this paper as [24]
The Stage 1 section identifies insulin, GAD65, IA-2, and ZnT8 autoantibodies as markers of presymptomatic type 1 diabetes; the Overview and Stage 3 sections also describe clinical symptoms at diagnosis. The paper does not say that combining marker results with clinical presentation distinguishes type 1 from type 2 diabetes in children or adults. (LLM, conf=0.83)
Experimental — accuracy not yet measured
At stage 1 of type 1 diabetes, the 5-year risk of developing symptomatic type 1 diabetes is ~44% overall but varies considerably based on number, titer, and specificity of autoantibodies as well as age of seroconversion and genetic risk.
“At stage 1, the 5-year risk of developing symptomatic type 1 diabetes is 44% overall but varies considerably based on number, titer, and speci fi city of autoantibodies as well as age of seroconversion and genetic risk (47).”
From 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes—2024 (2024) · cites this paper as [47]
The Overview of Staging, Stage 1 section gives an approximately 44% five-year risk, but specifically for children screened for genetic risk at birth who reached stage 1—not for all people at stage 1. The Stage 1 section supports variation by autoantibody number, titer and type, age at seroconversion, and HLA genotype. Page numbers were not provided in our copy. (LLM, conf=0.85)
Experimental — accuracy not yet measured
At stage 1 of type 1 diabetes, the 5-year risk of developing symptomatic type 1 diabetes is 44% overall but varies considerably based on number, titer, and specificity of autoantibodies as well as age of seroconversion and genetic risk.
“At stage 1, the 5-year risk of developing symptomatic type 1 diabetes is 44% overall but varies considerably based on number, titer, and specificity of autoantibodies as well as age of seroconversion and genetic risk (45).”
From 2. Diagnosis and classification of diabetes: standards of care in diabetes-2025 (2025) · cites this paper as [45]
The Overview of Staging, Stage 1 section gives an approximately 44% five-year risk for children screened for genetic risk at birth who reach stage 1, not an overall estimate for everyone at stage 1. The Stage 1 section supports variation by autoantibody number, titer and type, age at seroconversion, and HLA genotype. (LLM, conf=0.84)
Experimental — accuracy not yet measured
Three distinct stages of type 1 diabetes have been defined and serve as a framework for research and regulatory decision-making.
“Three distinct stages of type 1 diabetes have been defi ned ( Table 2.3 ) and serve as a framework for research and regulatory decisionmaking (40,47).”
From 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes—2024 (2024) · cites this paper as [47]
Multiple studies indicate that measuring islet autoantibodies in relatives of those with type 1 diabetes or in children from the general population can effectively identify those who will develop type 1 diabetes.
“Multiple studies indicate that measuring islet autoantibodies in relatives of those with type 1 diabetes (47) or in children from the general population (72,73) can effectively identify those who will develop type 1 diabetes.”
From 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes—2024 (2024) · cites this paper as [47]

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β cell death and dysfunction during type 1 diabetes development in at-risk individuals.
Herold, K., Usmani-Brown, S., Ghazi, T., Lebastchi, J., Beam, C., Bellin, M., Ledizet, M., Sosenko, J. M., Krischer, J., & Palmer, J. (2015) · Journal of Clinical Investigation · doi:10.1172/jci78142 · Cited by 131 · see citing works
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The intestinal microbiome in type 1 diabetes
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TEDDY–The Environmental Determinants of Diabetes in the Young: An Observational Clinical Trial
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The prediction of type 1 diabetes by multiple autoantibody levels and their incorporation into an autoantibody risk score in relatives of type 1 diabetic patients
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Noninvasive mapping of pancreatic inflammation in recent-onset type-1 diabetes patients
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Predictive value of intravenous glucose tolerance test insulin secretion less than or greater than the first percentile in islet cell antibody positive relatives of type 1 (insulin-dependent) diabetic patients
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Type 1 Diabetes TrialNet–An International Collaborative Clinical Trials Network
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Young children (<5 yr) and adolescents (>12 yr) with type 1 diabetes mellitus have low rate of partial remission: diabetic ketoacidosis is an important risk factor
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IDDM2/insulin VNTR modifies risk conferred by IDDM1/HLA for development of Type 1 diabetes and associated autoimmunity
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A Risk Score for Type 1 Diabetes Derived From Autoantibody-Positive Participants in the Diabetes Prevention Trial–Type 1
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Insulin Resistance and Progression to Type 1 Diabetes in the European Nicotinamide Diabetes Intervention Trial (ENDIT)
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GAD65 Autoantibodies Detected by Electrochemiluminescence Assay Identify High Risk for Type 1 Diabetes
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Decreased Cord-Blood Phospholipids in Young Age–at–Onset Type 1 Diabetes
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The prenatal environment and type 1 diabetes
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Familial Risk of Type I diabetes in European Children
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Incidence of diabetic ketoacidosis at diagnosis of type 1 diabetes in Colorado youth, 1998-2012
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Distinguishing Persistent Insulin Autoantibodies With Differential Risk
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Cord Serum Lipidome in Prediction of Islet Autoimmunity and Type 1 Diabetes
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IDDM1 and Multiple Family History of Type 1 Diabetes Combine to Identify Neonates at High Risk for Type 1 Diabetes
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Molecular Signatures Differentiate Immune States in Type 1 Diabetic Families
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Electrochemiluminescence Assays for Insulin and Glutamic Acid Decarboxylase Autoantibodies Improve Prediction of Type 1 Diabetes Risk
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Biomarker discovery study design for type 1 diabetes in The Environmental Determinants of Diabetes in the Young (TEDDY) study
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Incidence of Insulin-Dependent Diabetes Mellitus in Colorado
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The use of intermediate endpoints in the design of type 1 diabetes prevention trials
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Stepwise or Linear Decrease in Penetrance of Type 1 Diabetes With Lower-Risk HLA Genotypes Over the Past 40 Years
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HLA-Associated Insulin Autoantibody Formation in Newly Diagnosed Type I Diabetic Patients
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Development of a Quantitative Methylation-Specific Polymerase Chain Reaction Method for Monitoring Beta Cell Death in Type 1 Diabetes
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Diabetic Subjects Diagnosed Through the Diabetes Prevention Trial–Type 1 (DPT-1) Are Often Asymptomatic With Normal A1C at Diabetes Onset
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Prognostic Performance of Metabolic Indexes in Predicting Onset of Type 1 Diabetes
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The Metabolic Progression to Type 1 Diabetes as Indicated by Serial Oral Glucose Tolerance Testing in the Diabetes Prevention Trial–Type 1
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Effect of HLA Class I and Class II Alleles on Progression From Autoantibody Positivity to Overt Type 1 Diabetes in Children With Risk-Associated Class II Genotypes
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General population screening for type 1 diabetes
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Performance of HbA1c as an Early Diagnostic Indicator of Type 1 Diabetes in Children and Youth
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Reduced morbidity at diagnosis and improved glycemic control in children previously enrolled in DiPiS follow-up
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Detection of Islet β-Cell Death in Vivo by Multiplex PCR Analysis of Differentially Methylated DNA
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Metabolomics in the Studies of Islet Autoimmunity and Type 1 Diabetes
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Islet Autoantibody Testing: An End to the Trials and Tribulations?
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Metabolic tests to determine risk for type 1 diabetes in clinical trials
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Authors: Insel, R. A., Dunne, J. L., Atkinson, M. A., Chiang, J. L., Dabelea, D., Gottlieb, P. A., Greenbaum, C. J., Herold, K. C., Krischer, J. P., Lernmark, Å., Ratner, R. E., Rewers, M. J., Schatz, D. A., Skyler, J. S., Sosenko, J. M., & Ziegler, A.-G.
Affiliations: Breakthrough T1D (US)
University of Florida (US)
American Diabetes Association (US)
Colorado School of Public Health (US)
University of Colorado Health (US)
Benaroya Research Institute (US)
Yale University (US)
University of South Florida (US)
Lund University (SE)
University of Miami (US)
TUM Klinikum (DE)
Corresponding author: Insel, Richard A.
ORCID: Insel, Richard A.
Dunne, Jessica L.
Atkinson, Mark A.
Chiang, Jane L.
Dabelea, Dana
Gottlieb, Peter A.
Greenbaum, Carla J.
Herold, Kevan C.
Krischer, Jeffrey P.
Lernmark, Åke
Rewers, Marian J.
Schatz, Desmond A.
Skyler, Jay S.
Sosenko, Jay M.
Ziegler, Anette-G.
Venue: Diabetes Care
Publisher: American Diabetes Association
Published: 2015-09-15
Volume: 38
Issue: 10
Pages: 1964-1974
ISSN: 0149-5992 (ISSN-L)
1935-5548
DOI: 10.2337/dc15-1419
PMC: PMC5321245
OpenAlex: W1942296996
Cited by: 1,216
References: 134
Citations by year: 2026: 149 · 2025: 182 · 2024: 139 · 2023: 151 · 2022: 124 · 2021: 132 · 2020: 82 · 2019: 89 · 2018: 71 · 2017: 50 · 2016: 42 · 2015: 4
FWCI: 7.05
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Diabetes Care (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Lund University Publications (Lund University) (submittedVersion)
Site cant be reached (submittedVersion)
PuSH - Publication Server of Helmholtz Zentrum München (submittedVersion)
Funders: National Institute of Diabetes and Digestive and Kidney Diseases (UC4DK106993, UC4DK097835)
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, presymptomatic disease, disease staging, islet autoimmunity, islet autoantibodies, dysglycemia, disease prevention, precision medicine, clinical trial design, regulatory approval
MeSH terms: Autoantibodies, Diabetes Mellitus, Type 1, Humans, Prediabetic State, Prospective Studies, Societies, Medical, United States, Autoimmunity, Disease Progression, Genetic Predisposition to Disease, Early Diagnosis, Insulin-Secreting Cells

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