Epidemiologic Register on Diabetes and COVID-19 in Tunisia

NCT ID: NCT05603130

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 811 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2022-10-17

Brief Summary

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.

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.

Conditions

COVID-19 Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

routinely collected clinical information

medical history, epidemiological characteristics, clinical examination, biological assessment (blood glucose, NFS, CRP, D-dimer,etc...)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Les Laboratoires des Médicaments Stériles

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Faida AJILI, Pr.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine at the Military Hospital of Tunis

Locations

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

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

CoviDTUN

Identifier Type: -

Identifier Source: org_study_id