Adherence Intervention to Promote Optimal Use of Insulin Pumps in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frequency of Insulin Pump Adherence Behaviors
研究概览
简要总结
The overall objective of this study is to address the critical need of improving insulin pump adherence in adolescents with Type 1 Diabetes (T1D) by providing personalized intervention using evidence-based techniques during routine diabetes clinic visits at point of care.
详细描述
To achieve optimal use of the insulin pump, patients must engage in frequent Blood Glucose Monitoring (BGM) and insulin bolusing, and have an understanding of their relationship. BGM must occur and then it must be followed by a decision about what to do (or not do) regarding insulin bolusing. If insulin bolusing occurs in the absence of BGM, hypoglycemia and less than ideal glycemic control can occur. Of the few insulin pump adherence studies, only very basic adherence behaviors such as BGM and insulin bolusing frequency or number of hypoglycemic events have been reported.
The overall objective of this study is to address the critical need of improving insulin pump adherence in adolescents with T1D by providing personalized intervention using evidence-based techniques during routine diabetes clinic visits at point of care.
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
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 10-17 years
- •type 1 diabetes diagnosis at least 1 year
- •use insulin pump
排除标准
- •developmental delay
研究组 & 干预措施
Tailored feedback
Participants are provided a Tailored Feedback report based on data downloaded from their insulin pumps. Summaries are provided about insulin pump adherence behaviors and recommendations for improvement are made.
干预措施: Adherence behaviors and recommendations for improvement. (Behavioral)
Problem Solving
Participants receive a problem-solving session based on data downloaded from their insulin pumps. An insulin pump adherence behavior that needs improvement is targeted; goals are set and solutions generated.
干预措施: Adherence behavior that needs improvement is targeted (Behavioral)
Treatment as Usual
Standard of care as provided by the endocrinologist occurs.
结局指标
主要结局
Frequency of Insulin Pump Adherence Behaviors
时间窗: every 3 months up to 12 months
Frequency of blood glucose monitoring per day; frequency of carbohydrate inputs per day; frequency of insulin boluses per day; frequency of insulin boluses that follow a high (\>150 mg/dL) or very high (\>250mg/dL) blood glucose result.
次要结局
- Change in Glycemic Control (A1C)(every 3 months up to 12 months)