A Pilot of ONBOARD: OvercomiNg Barriers & Obstacles to Adopting Diabetes Devices for Adults With T1D
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c (HbA1c)
研究概览
简要总结
This study will create a comprehensive, multicomponent behavioral intervention package (ONBOARD; OvercomiNg Barriers & Obstacles to Adopting Diabetes Devices). ONBOARD will provide adults with type 1 diabetes (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 proposed research will create and refine the ONBOARD intervention for CGM use. Participants will be tracked using metrics of A1c, time in glucose target range, number of days using CGM, blood glucose (BG) downloads, diabetes problem solving, diabetes distress, and technology attitudes. The investigators will examine whether ONBOARD leads to improved diabetes and psychosocial outcomes and sustained CGM use. At the end of this study, the investigators will have created and refined a comprehensive, multicomponent intervention package to promote increased and sustained uptake of CGM and increase readiness for closed loop adoption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 screening
- •Subject is within first year of continuous glucose monitor use OR has not been using CGM regularly in the 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
Hemoglobin A1c (HbA1c)
时间窗: baseline, month 3
Glycated haemoglobin (HbA1c)
次要结局
- Percentage of Time in Range of Continuous Glucose Monitor Values Between 70 and 180 mg/dL(two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months))
- Diabetes Distress Scale for Type 1 Diabetes(baseline, month 3)
- Percentage of CGM Data Downloaded and Available for Analysis(two weeks prior to starting intervention and two weeks after the intervention (average approximately 3 months))
- Fear of Hypoglycemia - Worry Survey(baseline, month 3)
- INSPIRE Survey(baseline, month 3)
- Frequency of Blood Glucose Monitoring(3 months)
- Number of Participants Who Withdraw or Are Lost to Followup Over the Course of the Study(Duration of study participation (up to three months))
- Glucose Monitoring System Satisfaction Survey (GMSS-T1D)(baseline, month 3)
- Mean Glucose Level(baseline, month 3)
- Number of Eligible Individuals Who Agree to Participate in the Study(During screening visit (up to 50 minutes))
- Satisfaction With Intervention Survey(Month 3)
- Barriers to Diabetes Device Use Survey(baseline, month 3)
- Technology Use For Diabetes Problem Solving Scale(baseline, month 3)
- Diabetes Technology Attitudes Survey(Baseline, Month 3)
- Hypoglycemia Confidence Scale(baseline, month 3)
研究者
Molly Tanenbaum
Instructor
Stanford University