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临床试验 NCT06408207 针对1型糖尿病目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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CGM Academy for Youth With Type 1 Diabetes 90 随机化 虚拟
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临床试验NCT06408207是一项针对1型糖尿病的干预性研究试验，目前试验状态为招募中。试验始于2025年5月1日，计划招募90名患者。该研究由Children's Hospital Los Angeles主导，预计于2026年12月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月6日。
简要概括
The goal of this randomized clinical trial is to compare the effects of a virtual education curriculum in blood glucose variation of youth with type 1 diabetes wearing continuous glucose monitoring (CGM) device. The main questions the study aims to answer are:
- Do participants undertaking the proposed curriculum present improved glucose variation than participants of standard education?
- Explore relationships betw...
详细描述
Youth with type 1 diabetes (T1D) are at increased risk for kidney failure, vision loss, heart disease, and premature mortality due to challenges with glycemic excursions. Continuous glucose monitoring (CGM) systems represent an important advance in diabetes technology with significant advantages over self-monitored blood glucose and the potential to optimize glycemic management. Despite these advances, youth with T1D...显示更多
官方标题
Randomized Control Trial Evaluating the Impact of CGM Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 1 Diabetes
疾病
1型糖尿病其他研究标识符
- CHLA-23-00298
NCT编号
实际开始日期
2025-05-01
最近更新发布
2026-02-06
预计完成日期
2026-12-30
计划入组人数
90
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Continuous Glucose Monitoring
Glycemic Control
Diabetes Education
Type1 Diabetes
Glycemic Control
Diabetes Education
Type1 Diabetes
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性CGM Academy * receive an interactive workbook with problem-based learning scenarios and video links about CGM and glucose management strategies.
* participate in four in-depth online group sessions with diabetes care and education specialists
* complete questionnaires three times: at the time of study enrollment, week 4 and 6 months. | CGM Academy Educational materials as well as online sessions with diabetes educators. |
无干预Standard Diabetes Education * receive standard education provided to all patients at CHLA
* complete questionnaires three times: at the time of study enrollment, week 4 and 6 months. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Mean change in Hemoglobin A1c from baseline to 6 months | Change in Hemoglobin A1c | Baseline to 6 months |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Mean change in HbA1c (%) from baseline to 6 months. | Change in Hemoglobin A1c | Baseline to 6 months |
Mean change in CGM metrics measured by CGM readings | % Glucose Time in Range (70-180 mg/dL), % Glucose Time Below Range (\<70mg/dL), % Glucose Time Above Range (\>180mg/dL). | Week 4 & 6 months |
Change in perceived diabetes distress at baseline, week 4 & 6 months | The Problem Areas in Diabetes survey (PAID) is an 18-item survey to assess the perceived burden associated with diabetes. Youth and caregivers are given statements about diabetes-related issues and report on a 5-point Likert scale (0 = not a problem, 1 = minor problem, 2 = moderate problem, 3 = somewhat serious problem, 4 = serious problem) the degree to which the statements are a problem for them. Increasing scores denote increased burden perceived. | Baseline, Week 4 & 6 months |
Change in perceived diabetes family responsibility at baseline, week 4 & 6 months. | The Diabetes Family Responsibility Questionnaire (DFRQ) is a 14-item validated survey assessing parental and child involvement in various diabetes management tasks. Youth and caregivers report on a 3-point scale (1=child, 2=equal, 3=parent) who is responsible for a given diabetes task. Higher scores indicate more parental involvement in diabetes management. | Baseline, week 4 & 6 months |
Average number of diabetes educator hours used per study participant at week 4 & 6 months. | Number of hours spent in diabetes education | Week 4 and 6 months |
Perceived benefits of Continuous Glucose Monitor (CGM) use | Adolescent Benefits and Burdens of CGM Survey - BenCGM \& BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree. | week 4 & 6 months |
Perceived burden of Continuous Glucose Monitor (CGM) use | Adolescent Benefits and Burdens of CGM Survey - BenCGM \& BurCGM. Participants answer each question on a scale of Strong Disagree, Disagree, Neutral, Agree, Strongly Agree. | week 4 & 6 months |
参与助手
资格标准
适龄参与研究
儿童, 成人
最低年龄要求
8 Years
适龄性别
全部
- Current age of 8-18 years, age group eligible for CGM therapy with Dexcom G6 and G7
- T1D duration ≥6 months, as insulin adjustments during honeymoon stage differs from establishedT1D
- Able to speak, read, and write English or Spanish
- Smartphone compatible with Dexcom G6 and G7application
- Ability to participate in virtual visits
• Known history of medical adhesive allergies
Children's Hospital Los Angeles研究责任方
Barber, Rebecca, 主要研究者, Principal Investigator, Children's Hospital Los Angeles
研究中心联系人
联系人: Rebecca Barber, PhD, RN, (323) 361-1359, [email protected]
联系人: Natalia Garban, [email protected]
1 位于 1 个国家/地区的研究中心
California
Children's Hospital Los Angeles, Los Angeles, California, 90027, United States
Natalia Garban, 联系人, [email protected]
Rebecca Barber, PhD, RN, 主要研究者
招募中