Epidemiologic Register on Diabetes and COVID-19 in Tunisia

COVID-19 Disease Clinical Trial

Official title:

Diabetes and COVID-19 in Tunisia (CoviDTUN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05603130
• Other study ID #: CoviDTUN
• Status: Completed
• Start date: March 23, 2022
• Est. completion date: October 17, 2022

Study information

• Verified date: October 2022
• Source: Les Laboratoires des Médicaments Stériles
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 811
• Est. completion date: October 17, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Disease

Intervention

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

Locations

Country	Name	City	State
Tunisia	Autoimmune diseases research unit UR17DN02, Department of Internal Medicine at the Military Hospital of Tunis	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Les Laboratoires des Médicaments Stériles

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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