Supporting Parents of Young Children With Type 1 Diabetes in Closed-Loop System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Time spent in blood glucose range
研究概览
简要总结
This study will examine the impact of a closed-loop insulin delivery system intervention on health and psychological outcomes in families with 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
- Sequential
- 主要目的
- Supportive Care
- 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 since enrollment in the CEP 302 Trial:
- •Diagnosis of type 1 diabetes according to ADA diagnostic criteria
- •Time since diagnosis of at least six months
- •Age between 2.00 and 6.99 years at enrollment
- •Parental consent to participate in the study
- •Completion of the CEP 302 Trial and in the continuation phase of the Medtronic CEP 302 Trial using the Medtronic MiniMed 670G pump with Enlite3 sensor.
- •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.
- •The presence of any of the following is an exclusion for the study (since enrollment in the CEP 302 Trial):
- •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 & Technological Demands
Provide education on using diabetes technology in various settings and formats in this age group, and increase ability for real-time problem-solving. Identify and troubleshoot barriers to keeping young children in Auto Mode.
干预措施: Developmental & Technological 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)
Nutrition, Set Point, & C:I Ratio
Provide education on a variety of properties of food and how they affect blood glucose levels. Optimize the use of carbohydrate to Insulin ratios, insulin duration of action, and use of temporary target glucose set point in the 670G pump and the Quick bolus feature to gain better glycemic control.
干预措施: Nutrition, Set Point, & C:I Ratio (Behavioral)
Hypoglycemia management
Focus on hypoglycemia management to avoid hyperglycemia, review fear of hypoglycemia
干预措施: Hypoglycemia management (Behavioral)
Minimal Intervention
A short communication detailing the percentage of time spent in range and in Auto Mode and if the goals have been met.
干预措施: Minimal Intervention (Behavioral)
结局指标
主要结局
Time spent in blood glucose range
时间窗: Change over 3 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.
次要结局
- Hemoglobin A1c(Change over 3 months)
- Parent Diabetes Distress Scale(Change over 3 months)
- Patient Health Questionnaire 8(Change over 3 months)
- Pediatric Quality of Life Inventory(Change over 3 months)
- Glucose Monitoring System Satisfaction Survey(Change over 3 months)
- General and diabetes-specific technology use(Change over 3 months)
- Health care utilization(Change over 3 months)
- Problem Areas in Diabetes(Change over 3 months)
- State-Trait Anxiety Inventory(Change over 3 months)
- Pittsburgh Sleep Quality Index(Change over 3 months)
- Hypoglycemic Fear Survey - Parents(Change over 3 months)
- Hypoglycemia Confidence Questionnaire(Change over 3 months)
- Diabetes management behaviors(Change over 3 months)
研究者
Bruce A. Buckingham
Professor, Department of Pediatrics, Endocrinology and Diabetes Division
Stanford University