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Cited by 383Diabetes and associated disordersDiabetes Management and ResearchT-cell and B-cell Immunology

The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index.

Nasal insulin to prevent type 1 diabetes in children with HLA genotypes and autoantibodies conferring increased risk of disease: a double-blind, randomised controlled trial

Näntö-Salonen, Kirsti, Kupila, Antti, Simell, Satu, Siljander, Heli, Salonsaari, Tiina, Hekkala, Anne, Korhonen, Sari, Erkkola, Risto, Sipilä, Jukka I, Haavisto, Lotta, Siltala, Marja, Tuominen, Juhani, Hakalax, Jari, Hyöty, Heikki, Ilonen, Jorma, Veijola, Riitta, Simell, Tuula, Knip, Mikael, Simell, Olli·2008·The Lancet
DOI 10.1016/s0140-6736(08)61309-4
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Abstract

Background In mouse models of diabetes, prophylactic administration of insulin reduced incidence of the disease. We investigated whether administration of nasal insulin decreased the incidence of type 1 diabetes, in children with HLA genotypes and autoantibodies increasing the risk of the disease. Methods At three university hospitals in Turku, Oulu, and Tampere (Finland), we analysed cord blood samples of 116 720 consecutively born infants, and 3430 of their siblings, for the HLA-DQB1 susceptibility alleles for type 1 diabetes. 17 397 infants and 1613 siblings had increased genetic risk, of whom 11 225 and 1574, respectively, consented to screening of diabetes-associated autoantibodies at every 3-12 months. In a double-blind trial, we randomly assigned 224 infants and 40 siblings positive for two or more autoantibodies, in consecutive samples, to receive short-acting human insulin (1 unit/kg; n=115 and n=22) or placebo (n=109 and n=18) once a day intranasally. We used a restricted randomisation, stratified by site, with permuted blocks of size two. Primary endpoint was diagnosis of diabetes. Analysis was by intention to treat. The study was terminated early because insulin had no beneficial effect. This study is registered with ClinicalTrials.gov, number NCT00223613. Findings Median duration of the intervention was 1.8 years (range 0-9.7). Diabetes was diagnosed in 49 index children randomised to receive insulin, and in 47 randomised to placebo (hazard ratio [HR] 1.14; 95% C…

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Metadata

Authors
Näntö-Salonen, K., Kupila, A., Simell, S., Siljander, H., Salonsaari, T., Hekkala, A., Korhonen, S., Erkkola, R., Sipilä, J. I., Haavisto, L., Siltala, M., Tuominen, J., Hakalax, J., Hyöty, H., Ilonen, J., Veijola, R., Simell, T., Knip, M., & Simell, O.
Affiliations
  • University of Turku (FI)
  • University of Helsinki (FI)
  • Tampere University Hospital (FI)
  • University of Oulu (FI)
  • Tampere University (FI)
ORCID
Venue
The Lancet
Publisher
Elsevier BV
Published
2008-11
Volume
372
Issue
9651
Pages
1746-1755
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
DOI
10.1016/s0140-6736(08)61309-4
OpenAlex
W2157440365
Cited by
382
References
32
Citations by year
2026: 3 · 2025: 10 · 2024: 19 · 2023: 15 · 2022: 16 · 2021: 21 · 2020: 19 · 2019: 16 · 2018: 19 · 2017: 8 · 2016: 21 · 2015: 33 · 2014: 19 · 2013: 36 · 2012: 30
FWCI
18.28
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Life Sciences › Immunology and Microbiology › Immunology › T-cell and B-cell Immunology
Keywords
type 1 diabetes prevention, nasal insulin, diabetes-associated autoantibodies, high genetic risk, children, siblings, diabetes onset, diabetes screening, cord blood screening, early trial termination, diabetic mouse model, insulin resistance index
MeSH terms
Administration, Intranasal, Autoantibodies, Child, Child, Preschool, Diabetes Mellitus, Type 1, Double-Blind Method, Female, Finland, Genetic Testing, Genotype, HLA-DQ Antigens, Humans, Hypoglycemic Agents, Infant, Infant, Newborn, Insulin, Male, Risk Factors, HLA-DQ beta-Chains

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