Epidemiologic Register on Diabetes and COVID-19 in Tunisia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diabetes and COVID-19 in Tunisia (CoviDTUN)

Conditions
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COVID-19 Disease

Intervention / Treatment
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* Other: routinely collected clinical information


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: routinely collected clinical information|medical history, epidemiological characteristics, clinical examination, biological assessment (blood glucose, NFS, CRP, D-dimer,etc...)|

What is the study measuring?
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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 |