Incidence of Diabetes After a COVID-19 Infection - Comparison of COVID-19 Patients, Non-infected Individuals, Historic Controls and Patients With Influenza
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 157,134
- 试验地点
- 1
- 主要终点
- Other Diabetes mellitus
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Other Diabetes mellitus
时间窗: 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.
Type 1 Diabetes mellitus
时间窗: 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.
Type 2 Diabetes mellitus
时间窗: 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.
次要结局
- Fatigue(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.)
- Taste disorders(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.)