Randomized Control Trial Evaluating the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean change in Time in Range (TIR) from baseline to 6 months
研究概览
简要总结
The goal of this clinical trial is to evaluate the Impact of Continuous Glucose Monitoring Academy Education Curriculum Versus Standard Care on Glycemic Outcomes for Youth With Type 2 Diabetes (T2D):
- The first aim is to determine how feasible it is to adapt the Continuous Glucose Monitoring Academy curriculum to teach youth with T2D glucose management strategies.
- The second aim is to evaluate the effects of the Continuous Glucose Monitoring Academy metrics.
- The third aim is to explore the relationships between these metrics with diabetes distress, diabetes family responsibilities, and process metrics.
Participants will join for a total of four weeks of education, followed by a six-month clinical review. They will have access to an online workbook and videos, and will participate in virtual sessions with a diabetes educator who will cover glucose management strategies in-depth. Participants will wear their preferred Continuous Glucose Monitoring system (Dexcom or FreeStyle Libre) provided via insurance and inserted at the baseline visit.
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
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current age of 8-21 years;
- •T2D diagnosis;
- •Able to speak, read, and write English or Spanish
排除标准
- •a. Known history of medical adhesive allergies;
研究组 & 干预措施
Control
Receives standard of care, regular education in the clinic.
干预措施: Standard Education (Behavioral)
Continuous Glucose Monitoring Academy
Receive an interactive workbook with problem-based learning scenarios and video links about Continuous Glucose Monitoring and glucose management strategies (CGM Academy Program). 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.
干预措施: Continuous Glucose Monitoring Academy (Behavioral)
Continuous Glucose Monitoring Academy
Receive an interactive workbook with problem-based learning scenarios and video links about Continuous Glucose Monitoring and glucose management strategies (CGM Academy Program). 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.
干预措施: Standard Education (Behavioral)
结局指标
主要结局
Mean change in Time in Range (TIR) from baseline to 6 months
时间窗: Baseline to 6 months
Change in % glucose TIR (70-180 mg/dL)
次要结局
- Mean change in Hemoglobin A1c (HbA1c) from baseline to 6 months(Baseline to 6 months)
- Mean change in CGM metrics measured by CGM readings(Week 4 & 6 months)
- Change in perceived diabetes distress at baseline, week 4 & 6 months(Baseline, Week 4 & 6 months)
- Change in perceived diabetes family responsibility at baseline, week 4 & 6 months(Baseline, week 4 & 6 months)
- Average number of diabetes educator hours used per study participant at week 4 & 6 months.(Week 4 and 6 months)
- Mean change in perceived benefits of Continuous Glucose (CGM) Monitor use(Week 4 & 6 months)
- Mean change in perceived burden of Continuous Glucose Monitor (CGM) use(Week 4 & 6 months)
研究者
Barber, Rebecca
Nurse Scientist
Children's Hospital Los Angeles