Prevalence and Impact of Diabetes Mellitus in Hospitalized COVID-19 Patients in a Tunisian Center

May 8, 2023 updated by: Sana Rouis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

866

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Kairouan, Tunisia
        • Kairouan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

Confirmed cases indicated the patients whose real-time reverse transcriptase-polymerase chain reaction (RT-PCR) analysis results for nasal swab specimens were positive.

Exclusion Criteria:

  • 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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
diabetic patients with COVID-19
patients hospitalized for COVID-19 and were diabetic
Other: comparison of outcomes/exposure
analysing if diabetes mellitus have an impact on the primary outcomes: hospital stay, admission to the ICU, death.
Non-diabetic patients with COVID-19
patients hospitalized for COVID-19 and were not diabetic
Other: comparison of outcomes/exposure
analysing if diabetes mellitus have an impact on the primary outcomes: hospital stay, admission to the ICU, death.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Admission to Intensive Care Units
Time Frame: 7 days
patients who were transferred to ICU
7 days
death
Time Frame: 7 days
patients who were dead
7 days
overall length of hospital stay
Time Frame: 7 days
length of hospital stay from admission to discharge (or transfer or death)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sana Rouis

Investigators

  • Principal Investigator: sana rouis, MD, Faculty of Medicine, Sousse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2020

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRouis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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