Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT05524792
Brief Summary:
Prospective observational study of the POINTED consortium to evaluate whether new diagnoses of diabetes mellitus, occur significantly more frequently in the post-acute phase of a laboratory-confirmed SARS-CoV-2 infection than in carefully matched control groups.
Detailed Description:
Long-term health sequelae of the coronavirus disease 2019 (COVID-19) are a major public health concern. There is evidence on new-onset hyperglycaemia and insulin resistance in patients without history of diabetes in the post-acute phase of COVID-19 (Long-Covid).
This study is a longitudinal matched cohort study based on a total data pool of about 35 million SHI insured persons and investigates the incidence of a diabetes mellitus (differentiated into type 1, type 2 and other diabetes mellitus) diagnosis after confirmed SARS-Cov-2 infection compared to different control groups without SARS-Cov-2 infection. Individuals will be followed up from the date of diagnosis of SARS-Cov-2 infection, influenza diagnosis, or a randomly assigned index date for at least two quarters.
To assess effects of Long-Covid on incidence of diabetes mellitus, follow-up begins with the second quarter after the quarter of the index date.
The data analysis is carried out decentrally at the respective data holders of the POINTED consortium. Subsequently, the aggregated individual results are pooled.
Study:
NCT05524792
Study Brief:
Protocol Section:
NCT05524792