Incidence of Diabetes After a COVID-19 Infection

NCT ID: NCT05524792

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

157134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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COVID-19 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19

no interventional study

no interventional study

Intervention Type OTHER

no interventional study

Control I: No COVID-19

no interventional study

no interventional study

Intervention Type OTHER

no interventional study

Control II: Influenza 2018

no interventional study

no interventional study

Intervention Type OTHER

no interventional study

Control III: Historical 2018

no interventional study

no interventional study

Intervention Type OTHER

no interventional study

Interventions

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no interventional study

no interventional study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


\- 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


* Insured who were insured for at least one day between 01.01.2018 and 31.03.2019 (COVID-19 inclusion period minus 2 years)
* Insureds who were fully observable in 2017 and between 01.01.2018 and the end of the observation period (30.09.2019) or until death
* Alternative to two previous items: Insured who were fully observable from birth (between 01.01.2017 and 31.03.2019) to 30.09.2019 or until death


-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

* 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


-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)


* Insured with an outpatient confirmed E10-E14 diagnosis or an inpatient main or secondary E10-E14 diagnosis in the four quarters before the index quarter or without a corresponding diagnosis between birth and cohort entry (if period between birth and cohort entry \< four months)
* Insured who are not still alive on the first day of the second quarter after the index quarter.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Robert Koch Institut

OTHER_GOV

Sponsor Role collaborator

Center for Evidence-Based Healthcare, Technische Universität Dresden

UNKNOWN

Sponsor Role collaborator

Techniker Krankenkasse

OTHER

Sponsor Role collaborator

BARMER

OTHER

Sponsor Role collaborator

DAK Gesundheit

OTHER

Sponsor Role collaborator

AOK PLUS

INDUSTRY

Sponsor Role collaborator

Vandage GmbH

UNKNOWN

Sponsor Role collaborator

IKK Classic

UNKNOWN

Sponsor Role collaborator

InGef - Institute for Applied Health Research Berlin GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jochen Schmitt, Prof. Dr. med.

Role: STUDY_DIRECTOR

Center for Evidence-Based Healthcare, Technische Universität Dresden

Josephine Jacob, MSc

Role: PRINCIPAL_INVESTIGATOR

InGef - Institute for Applied Health Research Berlin GmbH

Christa Scheidt-Nave, Dr.

Role: PRINCIPAL_INVESTIGATOR

Robert Koch-Institut; Fachgebiet 25 - Körperliche Gesundheit

Lukas Reitzle, Dr.

Role: PRINCIPAL_INVESTIGATOR

Robert Koch-Institut; Fachgebiet 24: Gesundheits-bericht-erstattung

Locations

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Center for Evidence-Based Healthcare, Technische Universität Dresden

Dresden, , Germany

Site Status

Countries

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Germany

References

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Reitzle L, Ihle P, Heidemann C, Paprott R, Koster I, Schmidt C. [Algorithm for the Classification of Type 1 and Type 2 Diabetes Mellitus for the Analysis of Routine Data]. Gesundheitswesen. 2023 Mar;85(S 02):S119-S126. doi: 10.1055/a-1791-0918. Epub 2022 Jun 2. German.

Reference Type BACKGROUND
PMID: 35654399 (View on PubMed)

Other Identifiers

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2022-07 COVID-19 and diabetes

Identifier Type: -

Identifier Source: org_study_id

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