Center for Evidence-Based Healthcare, Technische Universität Dresden
Dresden, Germany
NCT Number: NCT05524792
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.
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Observational
Dresden, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(cohorts: COVID-19 and No COVID-19)
Additional inclusion criteria (cohort: COVID-19):
Exclusion criteria
Additional Exclusion criteria (cohort: no COVID-19):
-Insured with at least one COVID-19 diagnosis (U07.1 or U07.2) during the observation period (between 01.02.2020 and 30.09.2021)
Inclusion criteria
(cohorts: Influenza 2018 and Historical 2018)
Additional inclusion Criteria (cohort: Influenza 2018):
-Insured with at least one J10 diagnosis (Influenza) confirmed in an outpatient setting or an inpatient main or secondary J10 diagnosis between 01.02.2018 and 30.06.2018.
Exclusion criteria
no interventional study
Time frame: Starting with the second quarter following inclusion quarter until end of follow-up or death, whatever comes first. Time frame must be at least two quarters following inclusion quarter.
Patients with a newly documented, confirmed Type 1 Diabetes mellitus diagnosis. Based on a published algorithm (Reitzle et al. 2022) using ICD-10-GM diagnoses and ATC-codes.
Time frame: Starting with the second quarter following inclusion quarter until end of follow-up or death, whatever comes first. Time frame must be at least two quarters following inclusion quarter.
Patients with a newly documented, confirmed Type 2 Diabetes mellitus diagnosis. Based on a published algorithm using ICD-10-GM diagnoses and ATC-codes.
Time frame: Starting with the second quarter following inclusion quarter until end of follow-up or death, whatever comes first. Time frame must be at least two quarters following inclusion quarter.
Patients with a newly documented, confirmed "Other Diabetes mellitus" diagnosis. Based on a published algorithm using ICD-10-GM diagnoses and ATC-codes.
Time frame: Starting with the second quarter following inclusion quarter until end of follow-up or death, whatever comes first. Time frame must be at least two quarters following inclusion quarter.
Patients with at least one confirmed ambulatory or main or secondary inpatient diagnosis ICD-10-GM G93.3 Chronic fatigue syndrome.
Time frame: Starting with the second quarter following inclusion quarter until end of follow-up or death, whatever comes first. Time frame must be at least two quarters following inclusion quarter.
Patients with at least one confirmed ambulatory or main or secondary inpatient diagnosis ICD-10-GM R43 Taste diorders.
InGef - Institute for Applied Health Research Berlin GmbH
Industry
Incidence of Diabetes After a COVID-19 Infection - Comparison of COVID-19 Patients, Non-infected Individuals, Historic Controls and Patients With Influenza
Acronym: POINTED_Diab
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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