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

August 26, 2020 updated by: Yasmine Ibrahim Elhenawy, Ain Shams University

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

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.

Study Overview

Status

Unknown

Conditions

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).

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Khadiga Eltonbary

Study Locations

  • Egypt
      • Cairo, Egypt, 11765
        • Recruiting
        • Pediatrics and Adolescents Diabetes Unit (PADU), Pediatrics Hospital, Faculty of Medicine, Ain Shams University
        • Contact:
          • Yasmine Ehenawyl
          • Phone Number: +201006714334
        • Contact:
          • Khadiga Eltonbary
          • Phone Number: +201010477244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Data will be collected from patients who are conveniently available and willing to participate in the study in the period from July to August 2020, will be used. A questionnaire will be circulated among patients and/or their caregivers and can be filled online or through telephone calls.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of COVID-19 pandemic and lockdown on glycemic control among a sample of Egyptian children and adolescents with type 1 diabetes
Time Frame: 12 weeks
Change in HbA1c from baseline to 3 month after the lockdown
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of COVID-19 pandemic and lockdown on insulin dosage among a sample of Egyptian children and adolescents with type 1 diabetes
Time Frame: 12 weeks
Change in total insulin dosage from baseline to 3 month after the lockdown
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Yasmine Elhenawy, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU P66/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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