Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Hemoglobin A1c (HbA1c) Over Time
研究概览
简要总结
This study is a comprehensive, multicomponent behavioral intervention package (ONBOARD; OvercomiNg Barriers & Obstacles to Adopting Diabetes Devices). ONBOARD will provide adults with T1D the skills to maximize benefit and minimize daily interference from barriers associated with Continuous Glucose Monitoring (CGM) and increase readiness for closed loop.
详细描述
The investigators will enroll 178 adults with T1D between 18-50 years of age. Participants must not have been using CGM regularly for past 6 months. Once consented and enrolled, baseline demographic and psychosocial data will be obtained. Participants will receive 12 weeks of CGM supplies at no cost to them and provided with initial standard CGM introduction and education. Participants will then be randomized to receive ONBOARD or CGM-only. Those randomized to the ONBOARD condition will schedule 4 60-minute sessions with study interventionist (every 2 weeks). Hemoglobin A1c values, CGM usage data, and psychosocial data will be collected at baseline, 3-months (post-intervention), and 6- and 12-months post-baseline.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is age 18-50 years at time of enrollment
- •Subject must not have been using CGM regularly for past 6 months
- •Subject has a clinical diagnosis of type 1 diabetes
- •Subject comprehends spoken and written English
排除标准
- •Subject has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol.
- •Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol.
结局指标
主要结局
Change in Hemoglobin A1c (HbA1c) Over Time
时间窗: baseline, month 3, month 6, month 12
Glycated hemoglobin
Change in Hemoglobin A1c (HbA1c) Over Time
时间窗: baseline, month 3, month 6, month 12
Glycated hemoglobin
次要结局
- Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D)(baseline, month 3, month 6, month 12)
- Change in Time in Glucose Target Range(baseline, month 3, month 6, month 12)
- Change in Percent CGM Wear Time(baseline, month 3, month 6, month 12)
- Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS)(baseline, month 3, month 6, month 12)
- Change in Time in Glucose Target Range(baseline, month 3, month 6, month 12)
- Change in Percent CGM Wear Time(baseline, month 3, month 6, month 12)
- Change in Diabetes Distress Scale for Adults With Type 1 Diabetes (T1-DDS)(baseline, month 3, month 6, month 12)
- Change in Glucose Monitoring System Satisfaction Survey - Version: Type 1 Diabetes (GMSS-T1D)(baseline, month 3, month 6, month 12)
研究者
Molly Tanenbaum
Clinical Assistant Professor
Stanford University