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NCT Number: NCT04536285

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

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.

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Key information

Conditions

Type 1 Diabetes Acid-Base Imbalance Acidosis Autoimmune Diseases COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Ketoacidosis Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Infections Ketosis Lung Diseases Metabolic Diseases Nidovirales Infections Nutritional and Metabolic Diseases Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Cairo, 11765, Egypt

About this study

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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 4 months

    complications and comorbidities associated with diabetes

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

    Time frame: 4 months

    Acute phase reactants

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

    Time frame: 4 month

    Intensive care admission

Secondary outcomes

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

    Time frame: 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

    Time frame: 4 month

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 2, 2020
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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