Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 4
- 主要终点
- Time spent in blood glucose range
研究概览
简要总结
The primary objective of this project is to examine the impact of a continuous glucose monitoring (CGM) intervention on health and psychological outcomes in young children with type 1 diabetes (T1D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for the study, a child must meet the following criteria:
- •Diagnosis of type 1 diabetes according to American Diabetes Association diagnostic criteria
- •Time since diagnosis of at least six months
- •Age between 2 and 6 years at enrollment
- •Parental consent to participate in the study
- •No severe medical conditions, which in the opinion of the investigators are likely to hinder participation in this clinical trial.
- •If current use of CGM, A1c has to be above 7.5%; value obtained within 3 months of enrollment
- •Own and use an iPhone, or be willing/able to carry a study-supplied wi-fi enabled iPod
- •To be eligible for the study, a parent must meet the following criteria:
- •Parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above
- •Age of 18.0 years or older
- •Parent comprehends written English
- •Parent understands the study protocol and signs the informed consent document
- •Parent has access to a personal computer to upload diabetes devices and send to research team
- •The presence of any of the following is an exclusion for the study:
- •Child has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may hinder sensor application).
- •Child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol
- •Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- •Child is unable to completely avoid acetaminophen for duration of study
排除标准
- 未提供
研究组 & 干预措施
Developmental Demands
Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving.
干预措施: Developmental Demands (Behavioral)
Distress Reduction
Identify and reduce parent distress symptoms and worries. Provide strategies for obtaining social support.
干预措施: Distress Reduction (Behavioral)
Remote Monitoring
Optimize the use of remote monitoring by focusing on situational demands and problem solving.
干预措施: Remote Monitoring (Behavioral)
Fear of Hypoglycemia
Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.
干预措施: Fear of Hypoglycemia (Behavioral)
No Intervention
Serves as the control group comparator. No intervention provided.
干预措施: No intervention (Behavioral)
结局指标
主要结局
Time spent in blood glucose range
时间窗: Change over 6 months
Increasingly it is recognized that the percent time spent in a target blood glucose range, which is set by the American Diabetes Association, is an important outcome. This measure will be used as a primary outcome and derived from objective data downloads.
Pediatric Quality of Life Inventory
时间窗: Change over 6 months
This is a measure of health-related quality of life. It is used to understand the broader impact on quality of life which includes social, psychological, and health aspects of daily living.
次要结局
- Pittsburgh Sleep Quality Index(Change over 6 months)
- A1c(Change over 6 months)
- Diabetes Distress Scale(Change over 6 months)
- Patient Health Questionnaire 9(Change over 6 months)
- Problem Areas in Diabetes(Change over 6 months)
- State-Trait Anxiety Inventory(Change over 6 months)
- General and diabetes-specific technology use(Change over 6 months)
- Hypoglycemic Fear Survey(Change over 6 months)
- Hypoglycemic Confidence Questionnaire(Change over 6 months)
- Glucose Monitoring System Satisfaction Survey(Change over 6 months)
研究者
Korey Hood
Professor
Stanford University