Hb A1C Pre and Post Confinement in Latin American Children With Type 1 Diabetes: Dulce Study Group
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Hb A1C pre and post Confinement in Latin American children with Type 1 Diabetes
研究概览
简要总结
A multicenter retrospective observational study among children with type 1 diabetes will be performed. The Objective of this study will be to determine a) the association between the increase in Hba1c in children with type 1 diabetes and confinement due to the COVID 19 pandemic. b) the association between the frequency of patient care during social confinement and the Hba1c values. Different centers from Latin America including Argentina, Peru, Panama, Chile, and Ecuador will participate in this study. Children younger than 17 years with a diagnosis of type 1 diabetes prior to 2018 will be included. Data from the medical records of the participating centers will be collected on the Hb A1c value before and after confinement (6 months completed). The initial (base) value will be taken as a value of HbA1c registered in the patient's Clinical History for the year 2018, 2019, and 2020 pre and post quarantine (Sep-Oct-Nov) 2020, considering compliance with six months of quarantine. Hb A1c should have been performed in the same institution or with the same methods in order to avoid bias.
详细描述
Research protocol Hb A1C pre and post Confinement in Latin American children with Type 1 Diabetes: Dulce Study Group
The coronavirus disease is caused by an RNA virus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) that has spikes on its surface that give a crown appearance under the electron microscope; hence its name.
A recent cluster of pneumonia cases in Wuhan, China, was caused by this new coronavirus, SARS-CoV-2. In December 2019, adults in Wuhan, a central transportation hub in China, began presenting severe pneumonia of unknown origin in local hospitals. On December 31, 2019, China notified the WHO of the outbreak. On January 7, the virus was identified as a SARS-CoV-2. It soon became known that the disease could be transmitted from asymptomatic people and before the onset of symptoms. The infection is acquired either by inhaling drops or touching contaminated surfaces and then touching the nose, mouth, and eyes. The virus is also present in the stool.
The incubation period ranges from 2 to 14 d [median 5 d]. Studies have identified the angiotensin 2 receptor as the receptor through which the virus enters the respiratory mucosa. (1)
What happens in children? Less than 1% of the cases were in children under the age of 10 in Wuhan, China. Unlike adults, most children have a milder clinical course.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with type 1 diabetes younger than 17 years -
排除标准
- •pregnancy, kidney failure, treatments that alter hydrocarbon metabolism (corticosteroids, chemotherapy, etc.), and chronic iron deficiency pathologies that alter the value of HbA1c.
结局指标
主要结局
Hb A1C pre and post Confinement in Latin American children with Type 1 Diabetes
时间窗: six months
The increase in Hba1c in children with type 1 diabetes and confinement due to the COVID 19 pandemic
次要结局
未报告次要终点