Incidence of Diabetes After a COVID-19 Infection (POINTED_Diab)

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Diabetes Mellitus
• Intervention / Treatment: Other: no interventional study

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.

• Study Type: Observational
• Enrollment (Actual): 157134

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany
    • Center For Evidence-Based Healthcare, Technische Universität Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are insured in one of the data-contributing health insurance companies and meet the inclusion/exclusion criteria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19; no interventional study	Other: no interventional study; no interventional study
Control I: No COVID-19; no interventional study	Other: no interventional study; no interventional study
Control II: Influenza 2018; no interventional study	Other: no interventional study; no interventional study
Control III: Historical 2018; no interventional study	Other: no interventional study; no interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: InGef - Institute for Applied Health Research Berlin GmbH
• Collaborators: BARMER; Robert Koch Institut; Techniker Krankenkasse; DAK Gesundheit; AOK PLUS; IKK Classic; Center for Evidence-Based Healthcare, Technische Universität Dresden; Vandage GmbH
• Investigators: Study Director: Jochen Schmitt, Prof. Dr. med., Center For Evidence-Based Healthcare, Technische Universität Dresden; Principal Investigator: Josephine Jacob, MSc, InGef - Institute for Applied Health Research Berlin GmbH; Principal Investigator: Christa Scheidt-Nave, Dr., Robert Koch-Institut; Fachgebiet 25 - Körperliche Gesundheit; Principal Investigator: Lukas Reitzle, Dr., Robert Koch-Institut; Fachgebiet 24: Gesundheits-bericht-erstattung

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Long-COVID; Healthcare; Health claims data; Administative claims
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Endocrine System Diseases; COVID-19; Diabetes Mellitus
• Other Study ID Numbers: 2022-07 COVID-19 and diabetes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No