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临床试验/NCT04531111
NCT04531111Unknown不适用

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

Ain Shams University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年7月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Impact of COVID-19 pandemic and lockdown on glycemic control among a sample of Egyptian children and adolescents with type 1 diabetes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with type 1 diabetes and willing to participate in the study.
  • Age: less than 18 years old

排除标准

  • 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.

结局指标

主要结局

Impact of COVID-19 pandemic and lockdown on glycemic control among a sample of Egyptian children and adolescents with type 1 diabetes

时间窗: 12 weeks

Change in HbA1c from baseline to 3 month after the lockdown

次要结局

  • Impact of COVID-19 pandemic and lockdown on insulin dosage among a sample of Egyptian children and adolescents with type 1 diabetes(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasmine Ibrahim Elhenawy

Assistant Professor of Pediatrics

Ain Shams University

研究点 (1)

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