Epidemiologic Register on Diabetes and COVID-19 in Tunisia

Diabetes and COVID-19 in Tunisia (CoviDTUN)

CoviDTUN is a multicenter observatory set up by a steering committee to determine the presentation and evolution of diabetes in COVID-19 and study its pathogenesis.

The observatory comprises a dataset consisting of routinely collected clinical information anonymously to be entered by the investigator as a participating clinician/researcher.

The study will be an opportunity to understand the relationship between COVID-19 and diabetes, to enrich Tunisian data on diabetic and de novo diabetic patients who have contracted COVID-19 and to evaluate the prognostic severity factors for better management of these patients.

Study Overview

• Status: Completed
• Conditions: COVID-19 Disease
• Intervention / Treatment: Other: routinely collected clinical information

Detailed Description

It is a multicentric Tunisian observatory for COVID-19 patients. Confirmed COVID-19 patients, treated on an outpatient basis, in containment centers or hospitalized in COVID-19 units were included retrospectively from March 2020 and had continued prospectively til June 2022. The study had selected eligible patient recorded for inclusion by free practice physicians and hospital physicians. General data, medical history, epidemiological characteristics, clinical examination, biological assessment (blood glucose, NFS, CRP, D-dimer, etc.), clinical course and complications were therefore recorded in a structured and anonymized database. Data collection was carried out by DACIMA Clinical Suite® solution, in accordance with the normative and regulatory provisions in force in the management of health data.

• Study Type: Observational
• Enrollment (Actual): 811

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia
    • Autoimmune diseases research unit UR17DN02, Department of Internal Medicine at the Military Hospital of Tunis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Confirmed COVID-19 patients, treated on an outpatient basis, in containment centers or hospitalized in COVID-19 units.

Description

Inclusion Criteria:

• Diagnosis of COVID-19 infection confirmed by an evocative clinical picture according to INEAS score or a positive polymerase chain reaction [PCR] test and/or chest CT specific radiological signs and/or a rapid diagnostic antigen test.
• Diabetes known before COVID-19 (known diabetes patient before COVID-19: Diabetic patient before COVID-19: History in medical record and/or presence of antidiabetic therapy and/or HbA1c ≥ 6.5%).

or

- De novo diabetes (the de novo diabetic patient is defined as: Fasting blood glucose ≥ 1.26 g/L (7mmol/L) or postprandial blood glucose ≥ 2g/L (11.1 mmol/L) within 2 weeks of COVID-19 infection, no history of diabetes before the COVID-19 episode)).

Exclusion criteria:

• children
• pregnant women

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of patients with COVID-19 who have developed de novo diabetes.	The de novo diabetic patient is defined as follows: Fasting blood glucose ≥ 1.26 g/L (7mmol/L) or postprandial blood glucose ≥ 2g/L (11.1 mmol/L) within 2 weeks of COVID- 19 infection, no history of diabetes before the COVID-19 episode.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic characteristics of diabetic patients	age, weight, gender, BMI, age of diabetes, diabetes treatments, type of diabetes, diabetes complications, comorbidities (hypertension, heart disease, dyslipidemia), vaccination status (number of doses, type of vaccine), associated treatments, hospitalization, evolution (use of respiratory support, cure, death following COVID-19 infection in diabetic and non-diabetic patients).	3 months

Collaborators and Investigators

• Sponsor: Les Laboratoires des Médicaments Stériles
• Investigators: Principal Investigator: Faida AJILI, Pr., Department of Internal Medicine at the Military Hospital of Tunis

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 23, 2022
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): October 17, 2022

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (ACTUAL): November 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CoviDTUN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No