COVID-19POINTED_DiabNCT05524792

Incidence of Diabetes After a COVID-19 Infection

An observational study of COVID-19 and Diabetes Mellitus, run by InGef - Institute for Applied Health Research Berlin GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Any age
Conditions the study is for: COVID-19, Diabetes Mellitus
How many people: 157,134 participants
Where: 1 siteGermany
Study dates: 1 Jan 2018to 30 Sep 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

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)

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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.
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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Center for Evidence-Based Healthcare, Technische Universität Dresden
Dresden

Other trials in Germany

About this study

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

Read the 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.

Conditions: COVID-19, Diabetes Mellitus
Being tested: no interventional study
Keywords: Long-COVID, Diabetes Mellitus, Health claims data, Administative claims, Healthcare
Medical subject headings: COVID-19, Diabetes Mellitus, Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

no interventional studyOther
no interventional study

Study groups in NCT05524792
Study group	Role	What they receive
COVID-19		no interventional study Receives: Other: no interventional study
Control I: No COVID-19		no interventional study Receives: Other: no interventional study
Control II: Influenza 2018		no interventional study Receives: Other: no interventional study
Control III: Historical 2018		no interventional study Receives: Other: no interventional study

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
Patients with at least one confirmed ambulatory or main or secondary inpatient diagnosis ICD-10-GM G93.3 Chronic fatigue syndrome.
Measured: 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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201830 Sep 2021

First posted1 Sep 2022
Study start1 Jan 2018
Primary completion30 Sep 2021
Study completion30 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 157,134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05524792
Sponsor's protocol ID: 2022-07 COVID-19 and diabetes
Acronym: POINTED_Diab
Status last verified: Mar 2024
First submitted: 30 Aug 2022
Last updated: 25 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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.
PubMed 35654399

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Incidence of Diabetes After a COVID-19 Infection - Comparison of COVID-19 Patients, Non-infected Individuals, Historic Controls and Patients With Influenza
ClinicalTrials.gov ID: NCT05524792
Acronym / sponsor ID: POINTED_Diab / 2022-07 COVID-19 and diabetes
Conditions: COVID-19, Diabetes Mellitus
Keywords: Long-COVID, Diabetes Mellitus, Health claims data, Administative claims, Healthcare
Study type: Observational
Recruitment status: Completed
Enrolment: 157,134 participants (actual)
Lead sponsor: InGef - Institute for Applied Health Research Berlin GmbHIndustry (pharma, biotech, devices)
Collaborators: Robert Koch Institut, Center for Evidence-Based Healthcare, Technische Universität Dresden, Techniker Krankenkasse, BARMER, DAK Gesundheit, AOK PLUS, Vandage GmbH, IKK Classic
Study start: 1 Jan 2018 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 1 Sep 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
COVID-19	–	Other: no interventional studyno interventional study
Control I: No COVID-19	–	Other: no interventional studyno interventional study
Control II: Influenza 2018	–	Other: no interventional studyno interventional study
Control III: Historical 2018	–	Other: no interventional studyno interventional study

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients who are insured in one of the data-contributing health insurance companies and meet the inclusion/exclusion criteria.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (12 listed)

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)
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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
no interventional studyno interventional study	Other	COVID-19, Control I: No COVID-19, Control II: Influenza 2018, Control III: Historical 2018

Primary outcome

Type 1 Diabetes mellitus
Time frame: 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
Time frame: 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
Time frame: 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.

2 secondary outcomes

Fatigue
Time frame: 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
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
Background: PubMed 35654399Reitzle 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jochen Schmitt, Prof. Dr. med. study director

Center for Evidence-Based Healthcare, Technische Universität Dresden

Josephine Jacob, MSc principal investigator

InGef - Institute for Applied Health Research Berlin GmbH

Christa Scheidt-Nave, Dr. principal investigator

Robert Koch-Institut; Fachgebiet 25 - Körperliche Gesundheit

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Diabetes Mellitus, run by InGef - Institute for Applied Health Research Berlin GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Type 1 Diabetes mellitus (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05524792, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.