Evidence map›Paper›PMID 21515839›Full record

Trial reportDiabetes care2011

Primary dietary intervention study to reduce the risk of islet autoimmunity in children at increased risk for type 1 diabetes: the BABYDIET study.

Sandra Hummel, Maren Pflüger, Michael Hummel, Ezio Bonifacio, Anette-G Ziegler

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03037190 (Investigation Whether a Gluten Free Diet After the Onset of Type 1 Diabetes), which is not on this map. Cited by 97 papers.

0numbers the graph read from it
0cells of the map it votes in
97citing papers in PubMed
11.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT03037190 naunknown statusnot on this mapstarted 2015, after this paper: background citation

Investigation Whether a Gluten Free Diet After the Onset of Type 1 Diabetes (T1D) Can Better Preserve the Remaining Beta Cell Mass and at the Same Time Prevent the Development of Celiac Disease (CD) in These Patients.

TypeinterventionalSponsorLund UniversityRan2015 to 2020Enrolled160ConditionsDiabetes Mellitus, Type 1, Remission, Celiac Disease in ChildrenArmswithdrawal of gluten from the diet
3 · Its place in the literature

Who cites it

97 citing papers in PubMed, 216 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Type 1 Diabetes Mellitus Pathogenesis: Mechanisms, Early Diagnostic Strategies, and Emerging Therapeutic Approaches.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026
    Review
  4. Review
  5. Article
  6. Are We Ready With Prevention for Type 1 Diabetes?Diabetes/metabolism research and reviews · 2025
    Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Gamma-aminobutyric acid for delaying type 1 diabetes mellitus: an update.Annals of pediatric endocrinology & metabolism · 2024
    Article
  12. Article
  13. Review
  14. Screening and Prevention of Type 1 Diabetes: Where Are We?The Journal of clinical endocrinology and metabolism · 2023
    Review
  15. Article
  16. Review
  17. Review
  18. Prevention of Type 1 Diabetes in Children: A Worthy Challenge?International journal of environmental research and public health · 2023
    Review
  19. Review
  20. Updates of precision medicine in type 2 diabetes.Cambridge prisms. Precision medicine · 2023
    Review

37 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 1 country.

Sandra HummelInstitute for Diabetes Research, Helmholtz Zentrum München, Munich, Germany.
Maren Pflüger
Michael Hummel
Ezio Bonifacio
Anette-G Ziegler
Helmholtz Zentrum München · DEDeutsche Forschungsgemeinschaft · DEGerman Center for Diabetes Research · DEInstitute of Diabetes Research

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine whether delaying the introduction of gluten in infants with a genetic risk of islet autoimmunity is feasible, safe, and may reduce the risk of type 1 diabetes-associated islet autoimmunity. RESEARCH DESIGN AND

methodsA total of 150 infants with a first-degree family history of type 1 diabetes and a risk HLA genotype were randomly assigned to a first gluten exposure at age 6 months (control group) or 12 months (late-exposure group) and were followed 3 monthly until the age of 3 years and yearly thereafter for safety (for growth and autoantibodies to transglutaminase C [TGCAs]), islet autoantibodies to insulin, GAD, insulinoma-associated protein 2, and type 1 diabetes.

resultsAdherence to the dietary-intervention protocol was reported from 70% of families. During the first 3 years, weight and height were similar in children in the control and late-exposure groups, as was the probability of developing TGCAs (14 vs. 4%; P = 0.1). Eleven children in the control group and 13 children in the late-exposure group developed islet autoantibodies (3-year risk: 12 vs. 13%; P = 0.6). Seven children developed diabetes, including four in the late-exposure group. No significant differences were observed when children were analyzed as per protocol on the basis of the reported first gluten exposure of the children.

conclusionsDelaying gluten exposure until the age of 12 months is safe but does not substantially reduce the risk for islet autoimmunity in genetically at-risk children.

Indexed as

AutoantibodiesAutoimmunityCeliac DiseaseChild, PreschoolDiabetes Mellitus, Type 1GlutensGTP-Binding ProteinsHumansInfantInfant FoodIslets of LangerhansPilot ProjectsProtein Glutamine gamma Glutamyltransferase 2Risk FactorsTransglutaminasesAutoantibodiesGlutensGTP-Binding ProteinsProtein Glutamine gamma Glutamyltransferase 2Transglutaminases

Identifiers

PMID21515839
PMCPMC3114350
OpenAlexW2140973227

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.