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

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04536285
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Actual Duration (Months): 4
• Patients Per Site Per Month: 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes; Covid19

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.

• 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.

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

Study Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: 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
• Actual Study Start Date: May 1, 2020
• Actual Primary Completion Date: Aug 31, 2020
• Actual Study Completion Date: Aug 31, 2020

Outcome Measures

Primary Outcome Measures

1. Clinical characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. [4 months]

   complications and comorbidities associated with diabetes

2. Laboratory characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. [4 months]

   Acute phase reactants

3. Prognosis of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. [4 month]

   Intensive care admission

Secondary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pediatrics and Adolescents Diabetes Unit (PADU), Pediatrics Hospital, Faculty of Medicine, Ain Shams University	Cairo		Egypt	11765

Sponsors and Collaborators

• Ain Shams University

Investigators

• Study Director: Yasmine Elhenawy, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eman Monir Sherif, Professor of Pediatrics, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04536285
• Other Study ID Numbers: FMASU P59/2020
• First Posted: Sep 2, 2020
• Last Update Posted: Sep 2, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eman Monir Sherif, Professor of Pediatrics, Ain Shams University: Type 1 Diabetes; Covid 19; Diabetic ketoacidosis
• Additional relevant MeSH terms: COVID-19; Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Sep 2, 2020