ArticleDiabetologia2013
The use of intermediate endpoints in the design of type 1 diabetes prevention trials.
Article in Diabetologia, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06427421 (Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals), which is not on this map. Cited by 37 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Characterization of Autoreactive Regulatory and Conventional CD4 T Cells in Recent Onset Type 1 Diabetes and Control Individuals
Who cites it
37 citing papers in PubMed, 62 citations in OpenAlex.
- Trial
- 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2026.Diabetes care · 2026Review
- Type 1 Diabetes: A Guide to Autoimmune Mechanisms for Clinicians.Diabetes, obesity & metabolism · 2025Review
- From Prediction to Prevention: The Intricacies of Islet Autoantibodies in Type 1 Diabetes.Current diabetes reports · 2025Review
- REDEFINING AUTOIMMUNE DISEASES: THE OPPORTUNITY FOR PRECISION AND PREVENTION.Transactions of the American Clinical and Climatological Association · 2025Review
- 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2025.Diabetes care · 2025Review
- Postprandial Plasma Glucose.Clinical diabetes : a publication of the American Diabetes Association · 2025Review
- Review
- PRE1BRAZIL Protocol: A Randomized Controlled Trial to Evaluate the Effectiveness and Safety of the DPP-4 Inhibitor Alogliptin in Delaying the Progression of Stage 2 Type 1 Diabetes.Diabetes, metabolic syndrome and obesity : targets and therapy · 2024Article
- Plasma Glucose.Clinical diabetes : a publication of the American Diabetes Association · 2024Review
- 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2024.Diabetes care · 2024Review
- Heterogeneity and endotypes in type 1 diabetes mellitus.Nature reviews. Endocrinology · 2023Review
- Anti-Islet Autoantibodies in Type 1 Diabetes.International journal of molecular sciences · 2023Review
- Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies.Diabetologia · 2023Review
- Beta cell function in the early stages of type 1 diabetes: still a long way ahead of us.Pediatric endocrinology, diabetes, and metabolism · 2023Article
- First-emerging islet autoantibody and glucose metabolism: search for type 1 diabetes subtypes.Endocrine connections · 2022Article
- Rapid Point-of-Care Test for Determination of C-Peptide Levels.Journal of diabetes science and technology · 2022Article
- Article
- Early glucose metabolism in children at risk for type 1 diabetes based on islet autoantibodies compared to low-risk control groups.Frontiers in endocrinology · 2022Article
- Diagnosis and treatment of type 1 diabetes at the dawn of the personalized medicine era.Journal of translational medicine · 2021Review
Corrections and comments
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
Abstract
aims/hypothesisThis paper presents a rationale for the selection of intermediate endpoints to be used in the design of type 1 diabetes prevention clinical trials.
methodsRelatives of individuals diagnosed with type 1 diabetes were enrolled on the TrialNet Natural History Study and screened for diabetes-related autoantibodies. Those with two or more such autoantibodies were analysed with respect to increased HbA1c, decreased C-peptide following an OGTT, or abnormal OGTT values as intermediate markers of disease progression.
resultsOver 2 years, a 10% increase in HbA1c, and a 20% or 30% decrease in C-peptide from baseline, or progression to abnormal OGTT, occurred with a frequency between 20% and 41%. The 3- to 5-year risk of type 1 diabetes following each intermediate endpoint was high, namely 47% to 84%. The lower the incidence of the endpoint being reached, the higher the risk of diabetes. A diabetes prevention trial using these intermediate endpoints would require a 30% to 50% smaller sample size than one using type 1 diabetes as the endpoint. CONCLUSIONS/
interpretationThe use of an intermediate endpoint in diabetes prevention is based on the generally held view of disease progression from initial occurrence of autoantibodies through successive immunological and metabolic changes to manifest type 1 diabetes. Thus, these markers are suitable for randomised phase 2 trials, which can more rapidly screen promising new therapies, allowing them to be subsequently confirmed in definitive phase 3 trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.