NCT03290768已完成不适用
Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot (SMA Investigational Device)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 358
- 试验地点
- 2
- 主要终点
- Program Enrollment Rate (%)
研究概览
简要总结
This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor (CGM) as part of an educational program designed to help them better manage their glucose levels. Subjects will also wear an activity tracker to monitor their activity and observe its effect on their glucose levels. The educational program will involve calls from coaches to check subjects' progress and answer questions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be diagnosed with type 2 diabetes
- •Be able to read and understand English
- •Have access to a telephone
- •Have a Medicare Advantage health plan through Senior Dimensions
排除标准
- •Receiving chemotherapy or radiation to treat cancer (now or in past 6 months)
- •Misusing any drugs (including alcohol, painkillers, hallucinogens, or others)
- •Critically ill
- •Diagnosed with or experiencing:
- •Kidney disease stages 4 and 5
- •End stage renal disease
- •Severe liver disease
- •Schizophrenia
- •Bipolar disorder
- •An intellectual or learning disability
- •Arrhythmias other than atrial fibrillation
- •Congestive heart failure
- •Has had a:
- •Myocardial infarction within the last 6 months
- •Stroke within the last 6 months
- •Stroke that resulted in significant disability (e.g., unable to write clearly or walk)
结局指标
主要结局
Program Enrollment Rate (%)
时间窗: up to 9 months
(Number of patients who were shipped devices) / (Number of patients invited to enroll) \* 100
Program Completion Rate (%)
时间窗: up to 9 months
(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) \* 100
次要结局
- Coaching Participation Rate(up to 9 months)
- Change in Medication Dosage (mg/Day; U/Day)(up to 9 months)
- Average Age of Participants Who Complete Trial (Yrs)(up to 9 months)
- Weekly Average of Estimated Glucose Values (EGV)(up to 10 weeks)
- Average Age of Participants Who Start Trial (Yrs)(up to 9 months)
- Texting With Coaches(up to 9 months)
研究者
研究点 (2)
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