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Hospitalized Children and Adolescent Patients With Type 1 Diabetes During the COVID-19 Pandemic in Egypt

Completed
Conditions
Type 1 Diabetes
Covid19
Registration Number
NCT04536285
Lead Sponsor
Ain Shams University
Brief Summary

Although reports showed that children with well controlled diabetes do not appear to have increased risk of infection with SARS-CoV-2, however data are scarce regarding the extent to which clinical and demographic data of patient could modify the outcome and severity of the disease. Additionally, the link between covid-19 and diabetes remains controversial.

Detailed Description

Data from poorly controlled patients with type 1 diabetes remains controversial regarding whether diabetes itself could increases the susceptibility of infection with SARS-CoV-2 and subsequently impacts the outcomes in these patients , or the SARS-CoV-2 subsequently affects the risk of type 1 diabetes and increase in the prevalence of severe DKA.

Poorly controlled diabetes and chronic hyperglycemia creates a state of low grade chronic inflammation, which may explain the underlying mechanism of increased susceptibility to infection and infer the outcome in patients with diabetes .

Poorly controlled diabetes has been linked to multiple derangements of immune system including inhibition of lymphocyte proliferation in response to different stimuli, as well as impaired monocyte/macrophage function together with increased synthesis of pro-inflammatory cytokines and adhesion molecules that mediate tissue inflammation .

Few data links the association between development of diabetic ketoacidosis in patients with COVID-19, where the infection could trigger higher stressful conditions, with the release of stress hormones leading to increased blood glucose levels and abnormal glucose variability .

The extent to which clinical and demographic data of patients with type 1 diabetes modifies the outcome and severity of the disease seems entirely unclear and is the question of several researches.

ā€¢ Study Tools:

All patients admitted to Pediatrics Hospital, Ain Shams University in the period between May to August 2020 will be subjected to:

1- Detailed history 2. Thorough clinical examination: To assess the inclusion and exclusion criteria. A thorough clinical review to assess organ involvements and clinical and laboratory characteristics as well as the outcome measures in the studied cohort.

3. Data collection: Demographic and data will be extracted from patients inpatient files and reports

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
36
Inclusion Criteria
  • All patients with type 1 diabetes admitted to Pediatrics Hospital, Ain Shams University in the period between May to July 2020.
  • Age: less than 18 years old.
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Exclusion Criteria

ā€¢ Children with other forms of diabetes, including: type 2, monogenic forms and secondary diabetes

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Clinical characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.4 months

complications and comorbidities associated with diabetes

Laboratory characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.4 months

Acute phase reactants

Prognosis of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.4 month

Intensive care admission

Secondary Outcome Measures
NameTimeMethod
Incidence of new onset type 1 diabetes among confirmed cases of Covid-19 infection among children and adolescents4 months

Incidence of new onset type 1 diabetes among confirmed cases of Covid-19 infection among children and adolescents

Presentation of diabetes and its acute complications among pediatric and adolescent patients with type 1 diabetes during COVID-19 Pandemic in Egypt4 month

Impact of Covid-19 pandemic on presentation of diabetes and its acute complications among pediatric and adolescent patients with type 1 diabetes

Trial Locations

Locations (1)

Pediatrics and Adolescents Diabetes Unit (PADU), Pediatrics Hospital, Faculty of Medicine, Ain Shams University

šŸ‡ŖšŸ‡¬

Cairo, Egypt

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