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临床试验/NCT01295788
NCT01295788已完成不适用

Simultaneous vs Delayed Initiation of REAL-Time Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy

Children's Hospital of Eastern Ontario10 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
144
试验地点
10
主要终点
Adherence to CGM (hours per week)

研究概览

简要总结

The investigators hypothesize that REAL-Time Continuous Glucose Monitoring (RT-CGM) will be more effective if introduced in children and adolescents with established diabetes at the same time as they are starting pump therapy. This randomized controlled trial will compare the effectiveness of simultaneous vs delayed introduction of RT-CGM in children and adolescents with type 1 diabetes who are starting insulin pump therapy.

详细描述

REAL-Time Continuous Glucose Monitoring (RT-CGM) improves diabetes control in adults with type 1 diabetes. However, studies of RT-CGM in children and adolescents have been mostly negative. The lack of effectiveness in the pediatric population appears directly related to adherence to RT-CGM, i.e., the willingness of children and teens to wear and use this technology. Most previous RT-CGM studies have focused on experienced pump users or children with new-onset diabetes. At the time of pump initiation, children and adolescents who have been living with diabetes (and their parents) are highly motivated to make changes in their diabetes management and to take on additional responsibilities to improve their diabetes control and lifestyle, the two primary reasons for initiating pump therapy in the pediatric population. The investigators hypothesize that readiness for making changes in diabetes management will be greater at the time of pump initiation than at six months after the pump start. Further, the investigators hypothesize that readiness for change at the time of RT-CGM initiation will predict future adherence to RT-CGM and its effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Adherence to CGM (hours per week)

时间窗: one year

Number of hours of RT-CGM use per week

次要结局

  • Readiness for change(six months)
  • Treatment Satisfaction and Quality of Life(one year)
  • Perception of Barriers/Facilitators to RT-CGM Use(one year)
  • Barriers to Adherence(one year)
  • A1C(one year)
  • Fear of Hypoglycemia(one year)

研究者

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

Margaret Lawson

Professor of Pediatrics

Children's Hospital of Eastern Ontario

研究点 (10)

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