Glycemic Control Among Children and Adolescents With Type 1 Diabetes During COVID-19 Pandemic in Egypt

NCT ID: NCT04531111

Last Updated: 2020-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-07
• Study Completion Date: 2020-08-31

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).

Conditions

Type 1 Diabetes; Covid19

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Yasmine Ibrahim Elhenawy

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasmine Elhenawy

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Yasmine Elhenawy

Role: CONTACT

dr_yasmi@yahoo.com

+201006714334

Khadiga Eltonbary

Role: CONTACT

Facility Contacts

Yasmine Ehenawyl

Role: primary

+201006714334

Khadiga Eltonbary

Role: backup

+201010477244

Other Identifiers

FMASU P66/2020

Identifier Type: -

Identifier Source: org_study_id