Covid19NCT04663659
The Effect of Diabetes Mellitus on Mortality of Patients With COVID-19
An observational study of Covid19 and Diabetes Mellitus, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020. Retrospective records were examined by examining the electronic data files of the patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Diabetes Mellitus
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 15 May 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over 18 years of age with and without a medical history of DM in their history will be identified and compared in 2 groups
Who may be able to join
- All patients over 18 years of age
Who cannot join
- Patients under 18 years of age
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SisliHamidiye Etfal Education and Training Hospital
Istanbul, 34771
About this study
Official title: The Effect of Diabetes Mellitus on Mortality in Patients Hospitalized in the COVID Intensive Care Unit in the COVID-19 Pandemic
The study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020.
Retrospective records were examined by examining the electronic data files of the patients.
Polymerase Chain Reaction (PCR) tests performed with nasopharyngeal swab taken from the person, which is the standard diagnostic method, and also the diagnosis of infection symptoms, risk factors and thoracic CT scans indicating pneumonia were diagnosed.
Patients over 18 years of age with and without a medical history of DM in their history were identified and compared in 2 groups.
Read the detailed description
The study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020.
Retrospective records will be examined by examining the electronic data files of the patients.
Polymerase Chain Reaction (PCR) tests performed with nasopharyngeal swab taken from the person, which is the standard diagnostic method, and also the diagnosis of infection symptoms, risk factors and thoracic CT scans indicating pneumonia were diagnosed.
Patients over 18 years of age with and without a medical history of DM in their history will be identified and compared in 2 groups.
Demographic data such as age, gender, Body Mass Index (BMI) of all patients, presence of additional comorbid disease, blood glucose values during hospitalization in intensive care, ferritin, C-Reactive Protein (CRP), respiratory support methods (nasal oxygen, nasal high flow, non-invasive mechanical ventilation, intubation), length of stay in intensive care unit, and mortality will be recorded.
- Conditions
- Covid19, Diabetes Mellitus
- Being tested
- no intervention
- Medical subject headings
- COVID-19, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| diabetic group | Patients over the age of 18 with diabetes mellitus in intensive care unit Receives: Other: no intervention | |
| non-diabetic group | Patients over the age of 18 without diabetes mellitus in intensive care unit Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality rates of patients
Measured: 3 months
length of stay in intensive care
The time between admission to intensive care unit and discharge
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start15 Mar 2020
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermin Balta Başı, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Nermin Balta Basi, Principal investigator, Sisli Hamidiye Etfal Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663659
- Sponsor's protocol ID
- 1559
- Status last verified
- Dec 2020
- First submitted
- 10 Dec 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diabetes Mellitus on Mortality in Patients Hospitalized in the COVID Intensive Care Unit in the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04663659
- Acronym / sponsor ID
- 1559
- Conditions
- Covid19, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 11 Dec 2020 (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.
The study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020.
Retrospective records were examined by examining the electronic data files of the patients.
Polymerase Chain Reaction (PCR) tests performed with nasopharyngeal swab taken from the person, which is the standard diagnostic method, and also the diagnosis of infection symptoms, risk factors and thoracic CT scans indicating pneumonia were diagnosed.
Patients over 18 years of age with and without a medical history of DM in their history were identified and compared in 2 groups.
Detailed description
The study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020.
Retrospective records will be examined by examining the electronic data files of the patients.
Polymerase Chain Reaction (PCR) tests performed with nasopharyngeal swab taken from the person, which is the standard diagnostic method, and also the diagnosis of infection symptoms, risk factors and thoracic CT scans indicating pneumonia were diagnosed.
Patients over 18 years of age with and without a medical history of DM in their history will be identified and compared in 2 groups.
Demographic data such as age, gender, Body Mass Index (BMI) of all patients, presence of additional comorbid disease, blood glucose values during hospitalization in intensive care, ferritin, C-Reactive Protein (CRP), respiratory support methods (nasal oxygen, nasal high flow, non-invasive mechanical ventilation, intubation), length of stay in intensive care unit, and mortality will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic group | – | Other: no interventionPatients over the age of 18 with diabetes mellitus in intensive care unit |
| non-diabetic group | – | Other: no interventionPatients over the age of 18 without diabetes mellitus in intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age with and without a medical history of DM in their history will be identified and compared in 2 groups
Key inclusion criteria (1 listed)
- All patients over 18 years of age
Key exclusion criteria (1 listed)
- Patients under 18 years of age
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 interventionno intervention | Other | diabetic group, non-diabetic group |
Primary outcome
Mortality
Time frame: 3 months
Mortality rates of patients
length of stay in intensive care
Time frame: 3 months
The time between admission to intensive care unit and discharge
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 14 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
Nermin Balta Basi principal investigator
Sisli Hamidiye Etfal Education and Training Hospital
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 Covid19 and Diabetes Mellitus, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 14 Dec 2020. 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 Turkey (Türkiye). 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?
Mortality (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2020.