Type 1 Diabetes Risk and Severity after SARS-CoV-2 Infection or Vaccination
medrxiv(2024)
摘要
Aim: To clarify whether SARS-CoV-2 infection or vaccination contribute to risk of type 1 diabetes or more severe diabetes onset in children and young adults. Methods: We analysed cohorts of population-wide registries of young individuals from Norway (N=1,986,970) and Sweden (N=2,100,188). We used regression models to estimate adjusted rate ratios (aRR), treating exposures as time-varying, starting 30 days after registered SARS-CoV-2 positive test or vaccination. Results: Pooled results from Norway and Sweden and age-groups 12-17 and 18-29 years showed no significant increase in type 1 diabetes after documented infections (aRR 1.06, 95%CI:0.77-1.45). There was moderate heterogeneity, with a suggestive increased risk among children in Norway after infection. Pooled results for Norway and Sweden and age-groups 12-17 years and 18-29 years showed no significant association between SARS-CoV-2 vaccination and risk of type 1 diabetes (aRR 1.09, 95%CI: 0.81, 1.48). There was significant heterogeneity, primarily driven by a positive association among children and an inverse association in young adults in Sweden. While the type 1 diabetes incidence increased and diabetes ketoacidosis decreased over time during 2016-2023, no significant break in time-trends were seen after March 2020 for HbA1c, risk or severity of diabetic ketoacidosis, or islet autoantibodies, at diagnosis of type 1 diabetes. Conclusion: Taken together, these results do not indicate any consistent, large effects of SARS-CoV-2 infection or -vaccination on risk of type 1 diabetes or severity at disease onset. Suggestive associations in sub-groups should be investigated further in other studies. ### Competing Interest Statement Paz Lopez-Doriga Ruiz report participation in research projects funded by pharmaceutical companies (one on diabetes drug), all regulator-mandated Phase IV studies (PASS) unrelated to the submitted work, with all funds paid to their institution (no personal fees). Dr Sundstrom reported participating in research funded by governmental agencies, universities, Astellas Pharma, Janssen Biotech, AstraZeneca, Pfizer, Roche, (then) Abbott Laboratories, (then) Schering-Plough, UCB Nordic, and Sobi, with all funds paid to Karolinska Institutet, outside the submitted work. Dr Ljung reported receiving grants from Sanofi Aventis paid to his institution outside the submitted work; and receiving personal fees from Pfizer outside the submitted work. No other disclosures were reported. ### Funding Statement The work was done as part of regular work at the institutions where the authors had their primary affiliation, and no specific funding was obtained for these studies. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Norwegian Institute of Public Health is entitled by law to set up and use the preparedness register (Beredt C19) to help national and international authorities handle the pandemic. The emergency preparedness register was established according to the Health Preparedness Act paragraph 2-4. The study was approved by the Norwegian Regional Committee for Medical and Health Research Ethics South-East (REK Sor-Ost A, ref 122745), and has conformed to the principles embodied in the Declaration of Helsinki. Data from the Norwegian Childhood Diabetes Registry was routinely collected as part of the medical quality registry, and the use of data for this study together with BeredtC91 was approved by REK Sor-Ost A. Swedish Ethics approval: The Swedish study is approved by the Swedish Ethical Review Authority (2020-06859, 2021-02186) and has conformed to the principles embodied in the Declaration of Helsinki. Consent to participate is not applicable as this is a register-based study. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data privacy legislation in Norway and Sweden does not allow the authors to share individual level patient data. Researchers can apply for similar data to the respective registry holders after ethics approval in the respective countries. Researchers can apply for access to the Norwegian population health registry data by application to https://helsedata.no/, and for access to data from the Norwegian Childhood Diabetes by sending an application to barnediabetes@ous-hf.no. The Swedish Medical Products Agency will consider proposals for research collaboration. Enquiries can be submitted to the Swedish Medicines Agency (registrator@lakemedelsverket.se and CC rickard.ljung@lakemedelsverket.se).
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