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

Study Overview
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Brief Summary
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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
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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. • 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

Official Title
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Clinical Characteristics and Outcome of Hospitalized Children and Adolescent Patients With Type 1 Diabetes During the COVID-19 Pandemic: Data From a Single Center Surveillance Study in Egypt

Conditions
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Type 1 Diabetes, Covid19

Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: • Children with other forms of diabetes, including: type 2, monogenic forms and secondary diabetes

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. | complications and comorbidities associated with diabetes | 4 months | 
| Laboratory characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. | Acute phase reactants | 4 months | 
| Prognosis of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. | Intensive care admission | 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of new onset type 1 diabetes among confirmed cases of Covid-19 infection among children and adolescents | Incidence of new onset type 1 diabetes among confirmed cases of Covid-19 infection among children and adolescents | 4 months | 
| Presentation of diabetes and its acute complications among pediatric and adolescent patients with type 1 diabetes during COVID-19 Pandemic in Egypt | Impact of Covid-19 pandemic on presentation of diabetes and its acute complications among pediatric and adolescent patients with type 1 diabetes | 4 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Covid 19, Diabetic ketoacidosis