ArticleBMJ open2019
Oral insulin therapy for primary prevention of type 1 diabetes in infants with high genetic risk: the GPPAD-POInT (global platform for the prevention of autoimmune diabetes primary oral insulin trial) study protocol.
Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03364868 (Oral Insulin Therapy for Prevention of Autoimmune Diabetes), which is not on this map. Cited by 52 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Oral Insulin Therapy for Prevention of Autoimmune Diabetes
Who cites it
52 citing papers in PubMed, 1 synthesis or guideline pooled it, 87 citations in OpenAlex.
- ISPAD Clinical Practice Consensus Guidelines 2024: Screening, Staging, and Strategies to Preserve Beta-Cell Function in Children and Adolescents with Type 1 Diabetes.Hormone research in paediatrics · 2024Guideline
- Oral insulin immunotherapy in children at risk for type 1 diabetes in a randomised controlled trial.Diabetologia · 2021Trial
- Determinants of Infant Participation and Non-Participation in Primary Prevention Trials.Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme · 2026Article
- [Diabetes mellitus-definition, classification, diagnosis, screening and prevention (Update 2026)].Wiener klinische Wochenschrift · 2026Review
- Heterogeneity between insulin and proinsulin in the potency for insulin autoantibodies in newly diagnosed type 1 diabetes children.Clinical and experimental immunology · 2026Article
- Blood methylome signatures in children exposed to maternal type 1 diabetes are linked to protection against islet autoimmunity.Nature metabolism · 2025Article
- Type 1 diabetes mellitus prevention: present and future.Nature reviews. Endocrinology · 2025Review
- Perspectives on prevention of type 1 diabetes and heterogeneities.Diabetologia · 2025Review
- Are We Ready With Prevention for Type 1 Diabetes?Diabetes/metabolism research and reviews · 2025Review
- Genetics of circulating proteins in newborn babies at high risk of type 1 diabetes.Nature communications · 2025Article
- Anti-viral action against type 1 diabetes autoimmunity: The GPPAD-AVAnT1A study protocol.Contemporary clinical trials communications · 2025Article
- Epidemiology of type 1 diabetes in Podlasie region, Poland, in years 2010-2022 - 13-years-single-center study, including COVID-19 pandemic perspective.Pediatric endocrinology, diabetes, and metabolism · 2025Article
- Infection episodes and islet autoantibodies in children at increased risk for type 1 diabetes before and during the COVID-19 pandemic.Infection · 2024Article
- Oral Insulin Delay of Stage 3 Type 1 Diabetes Revisited in HLA DR4-DQ8 Participants in the TrialNet Oral Insulin Prevention Trial (TN07).Diabetes care · 2024Article
- A Review of Stage 0 Biomarkers in Type 1 Diabetes: The Holy Grail of Early Detection and Prevention?Journal of personalized medicine · 2024Review
- Environmental Determinants of Islet Autoimmunity (ENDIA) longitudinal prospective pregnancy to childhood cohort study of Australian children at risk of type 1 diabetes: parental demographics and birth information.BMJ open diabetes research & care · 2024Article
- Article
- Vitamin D insufficiency in infants with increased risk of developing type 1 diabetes: a secondary analysis of the POInT Study.BMJ paediatrics open · 2024Article
- Disrupted RNA editing in beta cells mimics early-stage type 1 diabetes.Cell metabolism · 2024Article
- Screening and Prevention of Type 1 Diabetes: Where Are We?The Journal of clinical endocrinology and metabolism · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 12 institutions in 7 countries.
Funding
Abstract
introductionThe POInT study, an investigator initiated, randomised, placebo-controlled, double-blind, multicentre primary prevention trial is conducted to determine whether daily administration of oral insulin, from age 4.0 months to 7.0 months until age 36.0 months to children with elevated genetic risk for type 1 diabetes, reduces the incidence of beta-cell autoantibodies and diabetes. METHODS AND ANALYSIS: Infants aged 4.0 to 7.0 months from Germany, Poland, Belgium, UK and Sweden are eligible if they have a >10.0% expected risk for developing multiple beta-cell autoantibodies as determined by genetic risk score or family history and human leucocyte antigen genotype. Infants are randomised 1:1 to daily oral insulin (7.5 mg for 2 months, 22.5 mg for 2 months, 67.5 mg until age 36.0 months) or placebo, and followed for a maximum of 7 years. Treatment and follow-up is stopped if a child develops diabetes. The primary outcome is the development of persistent confirmed multiple beta-cell autoantibodies or diabetes. Other outcomes are: (1) Any persistent confirmed beta-cell autoantibody (glutamic acid decarboxylase (GADA), IA-2A, autoantibodies to insulin (IAA) and zinc transporter 8 or tetraspanin 7), or diabetes, (2) Persistent confirmed IAA, (3) Persistent confirmed GADA and (4) Abnormal glucose tolerance or diabetes. ETHICS AND DISSEMINATION: The study is approved by the ethical committees of all participating clinical sites. The results will be disseminated through peer-reviewed journals and conference presentations and will be openly shared after completion of the trial. TRIAL REGISTRATION NUMBER: NCT03364868.
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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.