Incidence of Diabetes After a COVID-19 Infection

COVID-19 Clinical Trial

— POINTED_Diab  

Official title:

Incidence of Diabetes After a COVID-19 Infection - Comparison of COVID-19 Patients, Non-infected Individuals, Historic Controls and Patients With Influenza

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05524792
• Other study ID #: 2022-07 COVID-19 and diabetes
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2024
• Source: InGef - Institute for Applied Health Research Berlin GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157134
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 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)
• 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 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
• 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.

Related Conditions & MeSH terms

• COVID-19
• Diabetes Mellitus

Intervention

Other:
• no interventional study
no interventional study

Locations

Country	Name	City	State
Germany	Center for Evidence-Based Healthcare, Technische Universität Dresden	Dresden

Sponsors (9)

Lead Sponsor	Collaborator
InGef - Institute for Applied Health Research Berlin GmbH	AOK PLUS, BARMER, Center for Evidence-Based Healthcare, Technische Universität Dresden, DAK Gesundheit, IKK Classic, Robert Koch Institut, Techniker Krankenkasse, Vandage GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type 1 Diabetes mellitus	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.	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.
Primary	Type 2 Diabetes mellitus	Patients with a newly documented, confirmed Type 2 Diabetes mellitus diagnosis. Based on a published algorithm using ICD-10-GM diagnoses and ATC-codes.	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.
Primary	Other Diabetes mellitus	Patients with a newly documented, confirmed "Other Diabetes mellitus" diagnosis. Based on a published algorithm using ICD-10-GM diagnoses and ATC-codes.	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.
Secondary	Fatigue	Patients with at least one confirmed ambulatory or main or secondary inpatient diagnosis ICD-10-GM G93.3 Chronic fatigue syndrome.	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.
Secondary	Taste disorders	Patients with at least one confirmed ambulatory or main or secondary inpatient diagnosis ICD-10-GM R43 Taste diorders.	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.