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NCT05233592

Glycemic Effects of the COVID-19 Booster Vaccine in Type 1 Diabetes

Completed Last updated 17 May 2023
What this trial tests

trial testing CGM in Type 1 Diabetes in 21 participants. Completed in 4 April 2023.

Timeline
8 March 2022
Primary endpoint
4 April 2023
4 April 2023

Quick facts

Lead sponsorJohns Hopkins University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment21
Start date8 March 2022
Primary completion4 April 2023
Estimated completion4 April 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins University

Who can join

18 and older, any sex, with Type 1 Diabetes or Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Vaccines for COVID-19 are an essential part of combating the coronavirus pandemic. Vaccines "prime" the immune system against an invader (in this case the SARS-CoV-2 virus) by causing a temporary increased immune or inflammatory response. Inflammation can temporarily increase sugar levels and/or insulin requirements among patients with diabetes. The purpose of this study is to investigate whether the "booster" COVID-19 vaccine dose causes temporarily increased sugar levels and/or insulin dose requirements among patients with Type 1 Diabetes (T1D).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. COVID-19 Vaccines and Hyperglycemia-Is There a Need for Postvaccination Surveillance?
    Samuel SM, Varghese E, Triggle CR, Büsselberg D. · · 2022 · cited 20× · PMID 35335086 · DOI 10.3390/vaccines10030454
  2. European Safety Analysis of mRNA and Viral Vector COVID-19 Vaccines on Glucose Metabolism Events.
    di Mauro G, Mascolo A, Longo M, Maiorino MI, et al · · 2022 · cited 11× · PMID 35745596 · DOI 10.3390/ph15060677
  3. Transient Hyperglycemia in a Patient With Type 2 Diabetes After COVID-19 Messenger RNA Vaccination: A Case Report.
    Okon-Umoren A, Yaphe S, Smith A, Passalacqua KD, et al · · 2024 · PMID 39105031 · DOI 10.7759/cureus.63983

Verify or expand the search:

Other trials of CGM

Trials testing the same drug.

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

Other Johns Hopkins University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05233592.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing