NCT05524792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157,134

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

3.7 years

First QC Date

August 30, 2022

Last Update Submit

March 22, 2024

Conditions

COVID-19Diabetes Mellitus

Keywords

Long-COVIDDiabetes MellitusHealth claims dataAdministative claimsHealthcare

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • 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.

Study Arms (4)

COVID-19

no interventional study

Other: no interventional study

Control I: No COVID-19

no interventional study

Other: no interventional study

Control II: Influenza 2018

no interventional study

Other: no interventional study

Control III: Historical 2018

no interventional study

Other: no interventional study

Interventions

no interventional studyOTHER

no interventional study

COVID-19Control I: No COVID-19Control II: Influenza 2018Control III: Historical 2018

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Evidence-Based Healthcare, Technische Universität Dresden

Dresden, Germany

Location

Related 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.

    PMID: 35654399BACKGROUND

MeSH Terms

Conditions

COVID-19Diabetes MellitusPost-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jochen Schmitt, Prof. Dr. med.

    Center for Evidence-Based Healthcare, Technische Universität Dresden

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 1, 2022

Study Start

January 1, 2018

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

March 25, 2024

Record last verified: 2024-03

Locations

DE(1)