Simultaneous vs Delayed Initiation of REAL-Time Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 5
- 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
- 否
入选标准
- •Males and females age 5-18 years old.
- •Established T1D diagnosis for a minimum of one year.
- •Naïve to CSII therapy and ready to start CSII with the Veo pump (Medtronic) .
- •Willing to use RT-CGM and to be randomly assigned to either simultaneous or delayed RT-CGM initiation.
- •Regular diabetes follow up at one of the 5 participating sites.
- •Internet access at home (to upload RT-CGM data).
- •Parent(s) or legally acceptable representative able to speak and read English or French.
- •Ability of the subject and parent(s) or legally acceptable representative to participate in all aspects of this clinical trial.
- •Written informed consent must be obtained and documented, with assent of the child if <14 years of age.
排除标准
- •Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study.
- •Has received oral and/or intravenous steroid therapy (for any indication, at any dose and/or for any duration) on more than 2 separate occasions in the past 12 months. Use of inhaled and/or topical steroid therapy in the last 12 months does not exclude the subject.
- •Prior use of RT-CGM for more than 50% of the time over the past 6 months.
- •Prior enrollment in the current study.
- •Current enrollment in another intervention trial.
研究组 & 干预措施
Simultaneous RT-CGM and Pump Initiation
The experimental group will initiate RT-CGM at the same time as they begin insulin pump therapy.
干预措施: Simultaneous RT-CGM and Pump Initiation (Device)
Delayed RT-CGM Initiation
The control group will use standard pump therapy until the 6 month study visit at which time RT-CGM will be initiated.
干预措施: Delayed Initiation of RT-CGM (Device)
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
Margaret Lawson
Professor of Pediatrics
Children's Hospital of Eastern Ontario