COVID-19, Diabetes Mellitus
Conditions
Keywords
Long-COVID, Diabetes Mellitus, Health claims data, Administative claims, Healthcare
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.
Interventions
no interventional study
Sponsors
Robert Koch Institut
Center for Evidence-Based Healthcare, Technische Universität Dresden
Techniker Krankenkasse
BARMER
DAK Gesundheit
AOK PLUS
Vandage GmbH
IKK Classic
InGef - Institute for Applied Health Research Berlin GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
(cohorts: COVID-19 and No COVID-19) * Persons who were insured for at least one day between 01.01.2020 and 31.03.2021 * Insured who were fully observable in 2019, as well as between 01.01.2020 and the end of the available observation period (maximum 30.09.2021) or until death * Alternatively to two previous items: or insured who were born between 01.01.2019 and 31.03.2021 and were fully observable until the end of the observation period (30.09.2021) or death Additional inclusion criteria (cohort: COVID-19): \- Insured with at least one U07.1! confirmed outpatient diagnosis or an inpatient main or secondary diagnosis U07.1! between 01.02.2020 and 31.03.2021
Exclusion criteria
* Insured with an outpatient confirmed E10-E14 diagnosis or an inpatient main or secondary E10-E14 diagnosis in the four quarters prior to the COVID-19 index quarter or without a corresponding diagnosis between birth to cohort entry * Insured who are not alive on the first day of the second quarter after the index quarter Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type 1 Diabetes mellitus | 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 | 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. |
| Other Diabetes mellitus | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Patients with at least one confirmed ambulatory or main or secondary inpatient diagnosis ICD-10-GM G93.3 Chronic fatigue syndrome. |
| 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. | Patients with at least one confirmed ambulatory or main or secondary inpatient diagnosis ICD-10-GM R43 Taste diorders. |
Countries
Germany
Outcome results
None listed