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

NCT05851820 | Completed

• 1 other identifier: SRouis
• Study Type: observational
• Target: 866
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Prevalence; Diabetes Mellitus; Impaction; COVID-19

Keywords

diabetes mellitus; death; complications; COVID-19; SARS-CoV2; Intensive Care Units; Tunisia

Outcome Measures

Primary Outcomes (3)

• Admission to Intensive Care Units

  patients who were transferred to ICU

  7 days

• death

  patients who were dead

  7 days

• overall length of hospital stay

  length of hospital stay from admission to discharge (or transfer or death)

  7 days

Study Arms (2)

diabetic patients with COVID-19

patients hospitalized for COVID-19 and were diabetic

Other: comparison of outcomes/exposure

Non-diabetic patients with COVID-19

patients hospitalized for COVID-19 and were not diabetic

Other: comparison of outcomes/exposure

Interventions

comparison of outcomes/exposure OTHER

analysing if diabetes mellitus have an impact on the primary outcomes: hospital stay, admission to the ICU, death.

Non-diabetic patients with COVID-19; diabetic patients with COVID-19

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Sana Rouis: lead

Study Sites (1)

Kairouan

Kairouan, Tunisia

Location

Related Publications (5)

• 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.

  PMID: 32267833 BACKGROUND

• Apicella 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.

  PMID: 32687793 BACKGROUND

• Yang 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.

  PMID: 16759303 BACKGROUND

• Wu 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.

  PMID: 32496012 BACKGROUND

• Al-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.

  PMID: 32683744 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; COVID-19; Death

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• sana rouis, MD

  Faculty of Medicine, Sousse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor in Infectious Diseases

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 10, 2023
• Study Start: September 25, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

TU (1)