Clinical trial NCT05603130: Epidemiologic Register on Diabetes and COVID-19 in Tunisia
Official title: Diabetes and COVID-19 in Tunisia (CoviDTUN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Disease
Lead sponsor: Les Laboratoires des Médicaments Stériles
Sponsor class: INDUSTRY
First posted: 2022-11-02
Enrollment: 811
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Effectiveness of patients with COVID-19 who have developed de novo diabetes.
timeFrame: 3 months
Secondary outcomes:
measure: Demographic characteristics of diabetic patients
timeFrame: 3 months
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Autoimmune diseases research unit UR17DN02, Department of Internal Medicine at the Military Hospital of Tunis
Study officials:
affiliation: Department of Internal Medicine at the Military Hospital of Tunis
name: Faida AJILI, Pr.
role: PRINCIPAL_INVESTIGATOR
References: