Compliance to Obligatory and Recommended Vaccination in Children With Type 1 Diabetes Mellitus and Their Siblings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Time in Range (TIR) in children with T1D after switching to ultra-rapid insulin aspart
研究概览
简要总结
This is an observational, single-center, cross-sectional study about adherence to both obligatory and recommended vaccination in children with Type 1 Diabetes Mellitus and their siblings.
详细描述
A great amount of discussion has been made regarding the possible association between routine vaccinations and the risk of childhood type 1 diabetes mellitus. This study is designed to explore the level of compliance to obligatory and recommended vaccinations in children after being diagnosed with Type 1 Diabetes Mellitus and their siblings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate in the study
- •Informed consent obtained by parents or legal caregivers before any trial-related activities.
- •Documented diagnosis of tyoe 1 Diabetes mellitus in one children of the family
- •Written documents on vaccination schedules in participating subjects (children with Type 1 Diabetes and siblings)
排除标准
- •1. Communication problems
研究组 & 干预措施
Children with type 1 Diabetes
Retrospective analysis of their vaccination program
干预措施: Compliance to vaccination schedule (Behavioral)
Siblings of children with Typw 1 Diabetes
Retrospective analysis of their vaccination program
干预措施: Compliance to vaccination schedule (Behavioral)
结局指标
主要结局
Change in Time in Range (TIR) in children with T1D after switching to ultra-rapid insulin aspart
时间窗: 3-6 months after insulin switch
Percentage of time that interstitial glucose levels are between 70-180 mg/dL, measured using continuous or intermittent flash glucose monitoring (CGM or FreeStyle Libre®).
次要结局
- Change in Time Above Range (TAR) after switching to ultra-rapid insulin aspart(3-6 months after switching insulin)
- Change in Glycated Hemoglobin (A1c) after switching to ultra-rapid insulin aspart(12 months)
- Change in Time Below Range (TBR) after switching to ultra-rapid insulin aspart(3-6 months after switching insulin)
- Change in total daily insulin dose and basal/bolus proportions(3-6 months after switching insulin)
研究者
Athanasios Christoforidis
Assistant Professor in Pediatric Endocrinology
Aristotle University Of Thessaloniki