NCT03293082已完成不适用
The Effect of Continuous Glucose Monitoring Use on Glucose Variability in Preschool Children With Type 1 Diabetes
University of Ljubljana, Faculty of Medicine1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年9月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Glucose variability
研究概览
简要总结
The objectives of this clinical study is to evaluate the efficacy continuous glucose monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with CSII.
Downloads from CGM and CSII saved in pdf from will be retrospectively reviewed and analysed for all preschool children with type 1 diabetes in Slovenia. Glucose variability and other glycemic parameters will be analyzed separately for periods when CGM was used (CGM and SMBG data) and compared to periods when CGM was not used (SMBG only data).
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
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with Type 1 diabetes (> 6 months since diagnosis)
- •Insulin infusion pump CSII therapy for at least 3 months
- •Age ≤ 7 years
- •HbA1c at inclusion ≥ 6.5 and < 10
- •BMI SDS - below the 95th percentile for age
排除标准
- •Concomitant diseases that influence metabolic control
- •Participation in any other interventional study
- •Known or suspected allergy to trial products
结局指标
主要结局
Glucose variability
时间窗: Three years
Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose
次要结局
- Mean intersticial glucose(Three years)
- Mean blood glucose(Three years)
- HbA1c(Three years)
研究者
研究点 (1)
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