Continuous Glucose Monitoring and HbA1c in Children for Longterm Diabetes Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- HbA1c
研究概览
简要总结
The primary purpose of this pilot randomized controlled trial is to provide preliminary indicators of the effects of continuous subcutaneous insulin infusion with continuous glucose monitoring compared to self-monitoring of blood glucose alone on: (1) metabolic control and (2) fear of hypoglycemia. Additional objectives will be: (1) to provide an estimate of recruitment rates, (2) to assess compliance with allocated treatment, and (3) to determine participants' satisfaction with allocated treatment.
With increased and immediate information related to current and future (trend) glucose information provided by the continuous glucose monitor, children can then act upon this knowledge to prevent hypo- or hyperglycemia, thus, experiencing a reduction in glucose variability, leading to an improvement in metabolic control as shown by a reduction in HbA1c levels.
Research on the effectiveness of continuous glucose monitoring on metabolic control in children with T1D using continuous subcutaneous insulin infusion has been limited. Therefore, a pilot clinical trial will be designed to provide preliminary indicators of the feasibility and acceptability of continuous glucose monitoring on metabolic control and address the following objectives.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6-18 years
- •T1D for greater than one year;
- •Willing to perform at least three self-monitoring blood glucose tests per day;
- •Has been using continuous subcutaneous insulin infusion for more than one month
- •English speaking
排除标准
- •Presence of celiac disease (can cause malabsorption of nutrients affecting metabolic control)
- •Use of corticosteroids that have systemic effects and affect glucose levels
- •Currently using continuous glucose monitoring
- •Cognitively unable to self-manage, based on parent's and/or care provider's opinion
结局指标
主要结局
HbA1c
时间窗: 3 months
Metabolic control as measured by standard HbA1c
次要结局
- Fear of Hypoglycemia(3 months)
- Frequency of Hypoglycemia(3 months)
- Frequency of Hyperglycemia(3 months)
- Frequency of Diabetic Ketoacidosis(3 months)
研究者
Krystie Robinson-Vincent
PhD Candidate
University of Toronto