Epidemiologic Register on Diabetes and COVID-19 in Tunisia

NCT05603130 | Completed

• 1 other identifier: CoviDTUN
• Study Type: observational
• Target: 811
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Demographic characteristics of diabetic patients

  3 months

Interventions

routinely collected clinical information OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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%).
• \- 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)).

You may not qualify if:

• children
• pregnant women

Sponsors & Collaborators

• Les Laboratoires des Médicaments Stériles: lead

Study Sites (1)

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

Tunis, Tunisia

Location

Study Officials

• Faida AJILI, Pr.

  Department of Internal Medicine at the Military Hospital of Tunis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 2, 2022
• Study Start: March 23, 2022
• Primary Completion: June 30, 2022
• Study Completion: October 17, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)