Hospitalized Children and Adolescent Patients With Type 1 Diabetes During the COVID-19 Pandemic in Egypt
- Conditions
- Type 1 DiabetesCovid19
- 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
- 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.
ā¢ Children with other forms of diabetes, including: type 2, monogenic forms and secondary diabetes
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method Incidence of new onset type 1 diabetes among confirmed cases of Covid-19 infection among children and adolescents 4 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 Egypt 4 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
šŖš¬Cairo, Egypt