PrevalenceNCT05851820
Prevalence and Impact of Diabetes Mellitus in Hospitalized COVID-19 Patients in a Tunisian Center
An observational study of Prevalence and Diabetes Mellitus, run by Sana Rouis at 1 site in Tunisia.
Trial summary
Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19. Methods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Prevalence, Diabetes Mellitus, Impaction
- What is being tested?
- comparison of outcomes/exposure
- How many people
- 866 participants
- Where
- 1 siteTunisia
- Study dates
- 25 Sep 2020to 31 Aug 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Data collection is carried out from the medical records of patients using a standardized data collection form performed by the preventive medicine department of Ibn Al Jazzar's University Hospital. A trained team of family medicine residents accomplished the data collection. The variables included the following : Socio-demographic data, underlying comorbidities, symptoms and signs at admission, routine laboratory results, complications, treatment and outcomes. Patients were labelled as having diabetes mellitus if they were presently treated with insulin or oral hypoglycemic agents, and based on the patient's self-report on admission
Who may be able to join
- Confirmed cases indicated the patients whose real-time reverse transcriptase-polymerase chain reaction (RT-PCR) analysis results for nasal swab specimens were positive.
Who cannot join
- the investigators didn't included patients who were suspected cases, and whose the result of PCR test was negative ; Covid-19 patients admitted in other departments (Cardiology, pediatrics, obstetrics, intensive care unit, medicine, surgery department…) ; and patients with missing medical records. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Impact of Diabetes Mellitus in Hospitalized COVID-19 Patients in a Tunisian Center: a Cross Sectional Study
Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19.
Methods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death.
Read the detailed description
The outbreak of the coronavirus disease 2019 (Covid-19) has become an evolving worldwide health crisis. With the rising prevalence of diabetes mellitus has come an increasing awareness of their impacts on infectious diseases, and the risk for post-infection complications and mortality from critical infections.
Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19.
Methods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death. Association between diabetes and death was assessed in a Cox proportional hazards model.
- Conditions
- Prevalence, Diabetes Mellitus, Impaction, COVID-19
- Being tested
- comparison of outcomes/exposure
- Keywords
- diabetes mellitus, death, complications, COVID-19, SARS-CoV2, Intensive Care Units, Tunisia
- Medical subject headings
- Diabetes Mellitus, COVID-19, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparison of outcomes/exposureOther
analysing if diabetes mellitus have an impact on the primary outcomes: hospital stay, admission to the ICU, death.
| Study group | Role | What they receive |
|---|---|---|
| diabetic patients with COVID-19 | patients hospitalized for COVID-19 and were diabetic Receives: Other: comparison of outcomes/exposure | |
| Non-diabetic patients with COVID-19 | patients hospitalized for COVID-19 and were not diabetic Receives: Other: comparison of outcomes/exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission to Intensive Care Units
patients who were transferred to ICU
Measured: 7 days
death
patients who were dead
Measured: 7 days
overall length of hospital stay
length of hospital stay from admission to discharge (or transfer or death)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start25 Sep 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PrevalenceStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 866 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana Rouis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sana Rouis, Faculty of Medicine, Sousse
- Investigators
- sana rouis, MD, Principal investigator, Faculty of Medicine, Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851820
- Sponsor's protocol ID
- SRouis
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang B, Li R, Lu Z, Huang Y. Does comorbidity increase the risk of patients with COVID-19: evidence from meta-analysis. Aging (Albany NY). 2020 Apr 8;12(7):6049-6057. doi: 10.18632/aging.103000. Epub 2020 Apr 8.
PubMed 32267833Apicella M, Campopiano MC, Mantuano M, Mazoni L, Coppelli A, Del Prato S. COVID-19 in people with diabetes: understanding the reasons for worse outcomes. Lancet Diabetes Endocrinol. 2020 Sep;8(9):782-792. doi: 10.1016/S2213-8587(20)30238-2. Epub 2020 Jul 17.
PubMed 32687793Yang JK, Feng Y, Yuan MY, Yuan SY, Fu HJ, Wu BY, Sun GZ, Yang GR, Zhang XL, Wang L, Xu X, Xu XP, Chan JC. Plasma glucose levels and diabetes are independent predictors for mortality and morbidity in patients with SARS. Diabet Med. 2006 Jun;23(6):623-8. doi: 10.1111/j.1464-5491.2006.01861.x.
PubMed 16759303Wu J, Zhang J, Sun X, Wang L, Xu Y, Zhang Y, Liu X, Dong C. Influence of diabetes mellitus on the severity and fatality of SARS-CoV-2 (COVID-19) infection. Diabetes Obes Metab. 2020 Oct;22(10):1907-1914. doi: 10.1111/dom.14105. Epub 2020 Jul 7.
PubMed 32496012Al-Salameh A, Lanoix JP, Bennis Y, Andrejak C, Brochot E, Deschasse G, Dupont H, Goeb V, Jaureguy M, Lion S, Maizel J, Moyet J, Vaysse B, Desailloud R, Ganry O, Schmit JL, Lalau JD. Characteristics and outcomes of COVID-19 in hospitalized patients with and without diabetes. Diabetes Metab Res Rev. 2021 Mar;37(3):e3388. doi: 10.1002/dmrr.3388. Epub 2020 Aug 18.
PubMed 32683744
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Impact of Diabetes Mellitus in Hospitalized COVID-19 Patients in a Tunisian Center: a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT05851820
- Acronym / sponsor ID
- SRouis
- Conditions
- Prevalence, Diabetes Mellitus, Impaction, COVID-19
- Keywords
- diabetes mellitus, death, complications, COVID-19, SARS-CoV2, Intensive Care Units, Tunisia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 866 participants (actual)
- Lead sponsor
- Sana RouisUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 10 May 2023 (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.
Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19.
Methods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death.
Detailed description
The outbreak of the coronavirus disease 2019 (Covid-19) has become an evolving worldwide health crisis. With the rising prevalence of diabetes mellitus has come an increasing awareness of their impacts on infectious diseases, and the risk for post-infection complications and mortality from critical infections.
Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19.
Methods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death. Association between diabetes and death was assessed in a Cox proportional hazards model.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic patients with COVID-19 | – | Other: comparison of outcomes/exposurepatients hospitalized for COVID-19 and were diabetic |
| Non-diabetic patients with COVID-19 | – | Other: comparison of outcomes/exposurepatients hospitalized for COVID-19 and were not diabetic |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Data collection is carried out from the medical records of patients using a standardized data collection form performed by the preventive medicine department of Ibn Al Jazzar's University Hospital. A trained team of family medicine residents accomplished the data collection. The variables included the following : Socio-demographic data, underlying comorbidities, symptoms and signs at admission, routine laboratory results, complications, treatment and outcomes. Patients were labelled as having diabetes mellitus if they were presently treated with insulin or oral hypoglycemic agents, and based on the patient's self-report on admission
Key inclusion criteria (1 listed)
- Confirmed cases indicated the patients whose real-time reverse transcriptase-polymerase chain reaction (RT-PCR) analysis results for nasal swab specimens were positive.
Key exclusion criteria (1 listed)
- the investigators didn't included patients who were suspected cases, and whose the result of PCR test was negative ; Covid-19 patients admitted in other departments (Cardiology, pediatrics, obstetrics, intensive care unit, medicine, surgery department…) ; and patients with missing medical records. -
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 |
|---|---|---|
| comparison of outcomes/exposureanalysing if diabetes mellitus have an impact on the primary outcomes: hospital stay, admission to the ICU, death. | Other | Non-diabetic patients with COVID-19, diabetic patients with COVID-19 |
Primary outcome
Admission to Intensive Care Units
Time frame: 7 days
patients who were transferred to ICU
death
Time frame: 7 days
patients who were dead
overall length of hospital stay
Time frame: 7 days
length of hospital stay from admission to discharge (or transfer or death)
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 10 May 2023.
- Background: PubMed 32267833Wang B, Li R, Lu Z, Huang Y. Does comorbidity increase the risk of patients with COVID-19: evidence from meta-analysis. Aging (Albany NY). 2020 Apr 8;12(7):6049-6057. doi: 10.18632/aging.103000. Epub 2020 Apr 8.
- Background: PubMed 32687793Apicella M, Campopiano MC, Mantuano M, Mazoni L, Coppelli A, Del Prato S. COVID-19 in people with diabetes: understanding the reasons for worse outcomes. Lancet Diabetes Endocrinol. 2020 Sep;8(9):782-792. doi: 10.1016/S2213-8587(20)30238-2. Epub 2020 Jul 17.
- Background: PubMed 16759303Yang JK, Feng Y, Yuan MY, Yuan SY, Fu HJ, Wu BY, Sun GZ, Yang GR, Zhang XL, Wang L, Xu X, Xu XP, Chan JC. Plasma glucose levels and diabetes are independent predictors for mortality and morbidity in patients with SARS. Diabet Med. 2006 Jun;23(6):623-8. doi: 10.1111/j.1464-5491.2006.01861.x.
- Background: PubMed 32496012Wu J, Zhang J, Sun X, Wang L, Xu Y, Zhang Y, Liu X, Dong C. Influence of diabetes mellitus on the severity and fatality of SARS-CoV-2 (COVID-19) infection. Diabetes Obes Metab. 2020 Oct;22(10):1907-1914. doi: 10.1111/dom.14105. Epub 2020 Jul 7.
- Background: PubMed 32683744Al-Salameh A, Lanoix JP, Bennis Y, Andrejak C, Brochot E, Deschasse G, Dupont H, Goeb V, Jaureguy M, Lion S, Maizel J, Moyet J, Vaysse B, Desailloud R, Ganry O, Schmit JL, Lalau JD. Characteristics and outcomes of COVID-19 in hospitalized patients with and without diabetes. Diabetes Metab Res Rev. 2021 Mar;37(3):e3388. doi: 10.1002/dmrr.3388. Epub 2020 Aug 18.
- 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.
sana rouis, MD principal investigator
Faculty of Medicine, Sousse
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 Prevalence and Diabetes Mellitus, run by Sana Rouis at 1 site in Tunisia.
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 10 May 2023. 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 Tunisia. 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?
Admission to Intensive Care Units (time frame: 7 days). 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 NCT05851820, which also lists 5 linked publications.
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 10 May 2023.