Remote Monitoring of Diabetes in Young Children With Type 1 Diabetes
2019年11月7日 更新者:Korey Hood、Stanford University
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).
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
92
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
Stanford、California、美国、94305
- Stanford University
-
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Colorado
-
Aurora、Colorado、美国、80045
- University of Colorado
-
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Florida
-
Tampa、Florida、美国、33620
- University of South Florida
-
-
Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
2年 至 6年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:减轻痛苦
识别并减少父母的痛苦症状和担忧。
提供获得社会支持的策略。
|
减少痛苦的教育和培训
|
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实验性的: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.
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Education and training related to use of CGM in this age group
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实验性的:Remote Monitoring
Optimize the use of remote monitoring by focusing on situational demands and problem solving.
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Education and training on the use of remote monitoring
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实验性的:Fear of Hypoglycemia
Decrease fear of hypoglycemia, particularly focusing on overnight glycemic control.
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Education and training on reducing fear of hypoglycemia
|
|
安慰剂比较:No Intervention
Serves as the control group comparator.
No intervention provided.
|
No intervention - serves as the control group
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time spent in blood glucose range
大体时间: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.
|
Change over 6 months
|
|
Pediatric Quality of Life Inventory
大体时间: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.
|
Change over 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
A1c
大体时间:Change over 6 months
|
The hemoglobin A1c value is a biologic measure of the glycemia that is the gold standard measure of "control" of diabetes.
Collected through a blood sample.
|
Change over 6 months
|
|
Problem Areas in Diabetes
大体时间:Change over 6 months
|
This measure captures areas that are reported as problems for people with diabetes.
Participants in the study report on daily problems with diabetes via this measure.
|
Change over 6 months
|
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Diabetes Distress Scale
大体时间:Change over 6 months
|
This measure is widely used to capture the psychological distress experienced in relation to diabetes.
|
Change over 6 months
|
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Patient Health Questionnaire 9
大体时间:Change over 6 months
|
This is a widely used measure that captures depressive symptoms.
It is reported by the participants.
|
Change over 6 months
|
|
State-Trait Anxiety Inventory
大体时间:Change over 6 months
|
This is a widely used measure of anxiety symptoms.
It is reported by the participant.
|
Change over 6 months
|
|
Pittsburgh Sleep Quality Index
大体时间:Change over 6 months
|
This questionnaire measures the degree to which sleep is disrupted and the quality of sleep experienced by participants.
|
Change over 6 months
|
|
Hypoglycemic Fear Survey
大体时间:Change over 6 months
|
People with diabetes worry about hypoglycemia.
This measure captures those worries and is reported by participants.
|
Change over 6 months
|
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Hypoglycemic Confidence Questionnaire
大体时间:Change over 6 months
|
Hypoglycemia needs to be managed in various daily situations.
This questionnaire captures confidence of the participants in those various situations.
|
Change over 6 months
|
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Glucose Monitoring System Satisfaction Survey
大体时间:Change over 6 months
|
This a measure used to capture overall satisfaction with glucose monitoring devices used by participants.
|
Change over 6 months
|
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General and diabetes-specific technology use
大体时间:Change over 6 months
|
This measure has questions on attitudes and use of various general technologies (e.g., smartphone) and diabetes devices.
|
Change over 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Linda DiMeglio, MD、Indiana University
- 首席研究员:Kimberly Driscoll, PhD、University of Colorado, Denver
- 首席研究员:Henry Rodriguez, MD、University of South Florida
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年8月15日
初级完成 (实际的)
2019年4月1日
研究完成 (实际的)
2019年4月1日
研究注册日期
首次提交
2016年7月25日
首先提交符合 QC 标准的
2016年7月25日
首次发布 (估计)
2016年7月28日
研究记录更新
最后更新发布 (实际的)
2019年11月12日
上次提交的符合 QC 标准的更新
2019年11月7日
最后验证
2019年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.