Official Title
Glycemic Control Among Children and Adolescents With Type 1 Diabetes During COVID-19 Pandemic in Egypt: A Pilot Study
Brief Summary

During the current unusual situation with COVID-19 pandemic and the lockdown applied in most of the countries, school students were kept at home and offered e-learning modules and all activities were suspended. Lockdown entails significant modifications of life style, involving changes in physical activities, dietary habits and nutrition, which are likely to impact glycemic control. So the aim of the current study is to evaluate the impact of COVID-19 pandemic on glycemic control among children and adolescents with type 1 diabetes.

Detailed Description

All aspects of life were significantly impacted by the COVID-19 pandemic. The pandemic
created heavy burdens on all countries affecting all foundations of the country. Global
measures aimed to limit spread of COVID- 19 infection and a series of restriction were
announced by serial countries including the suspension of schools, organized sports
activities and gatherings. On March, 2020 Egypt started to take a series of lockdown
regulation to control the spread of infection.

The restriction and lockdown will impact the whole population especially populations with
chronic disease. It is known that the lockdown will render access to outpatient clinics and
services,beside the possible limitation of access to care, the restrictions may affect
glycemic control patients with diabetes.

The negative impact of limiting physical exercise, behavioral changes, dietary changes and
fear of shortage of medical supplies could have an influence on diabetes control.

Study procedure:

All included patients / caregivers will complete an online questionnaire. For patients with
limited internet access, the questionnaire will be carried out through phone calls according
to patients' convenience.

Perceived stress scale-10 (Arabic Validated version) will be used to measure patients'/
caregivers' level of stress in response to the extraordinary status of the pandemic and its
consequences. The scale is a 10 questions scale that will be circulated among the patients as
an Arabic validated electronic form .

Medical reports and files of included patients will be reviewed and last visit before the
lock down will be thoroughly evaluated to identify:

- Patients' body weight, body mass index.

- Insulin regimen with special emphasis on total daily dose and percentage of basal
insulin.

- Glycemic control of patients by evaluating the last HbA1C After completing the
questionnaire, patients' insulin dosage and glycemic control during the quarantine
period will be re-evaluated.

Evaluation of glycemic control at the end of the study:

- For patients on self- monitoring of blood glucose, a rapid Hba1c test will be done
according to patients' convenience, patterns and frequency of hypoglycemia and
hyperglycemia will be evaluated.

- For those on continous glucose monitoring ( if available), the data will be extracted
from the ambulatory glucose profile(AGP).

Unknown status
Type 1 Diabetes
COVID19
Eligibility Criteria

Inclusion Criteria:

- Patients with type 1 diabetes and willing to participate in the study.

- Age: less than 18 years old

Exclusion Criteria:

- Newly diagnosed patients with type 1 diabetes and those in honeymoon period.

- Children with other forms of diabetes, including: type 2, monogenic forms and
secondary diabetes.

- Patients with any other chronic disease.

Eligibility Gender
All
Eligibility Age
Minimum: 2 Years ~ Maximum: 18 Years
Countries
Egypt
Locations

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

Investigator: Yasmine Ehenawyl
Contact: +201006714334

Contacts

Yasmine Elhenawy
+201006714334
dr_yasmi@yahoo.com

Khadiga Eltonbary

Yasmine Elhenawy, Principal Investigator
Ain Shams University

Ain Shams University
NCT Number
Keywords
Type 1 Diabetes
Glycemic control
Covid-19
MeSH Terms
COVID-19
Diabetes Mellitus
Diabetes Mellitus, Type 1