Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Program Completion 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
- •Currently take a DPP4 inhibitor, SGLT2 inhibitor, GLP-1 agonist, and/or basal insulin
- •Be able to read and understand English
- •Have access to a telephone
- •Have a Medicare health plan
排除标准
- •Currently receiving chemotherapy or radiation therapy to treat cancer
- •Addicted to 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)
研究组 & 干预措施
Diabetes Management Educational Program
Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.
干预措施: Continuous Glucose Monitor (CGM) (Device)
Diabetes Management Educational Program
Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.
干预措施: Activity Tracker (Device)
Diabetes Management Educational Program
Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.
干预措施: Coaching (Behavioral)
结局指标
主要结局
Program Completion Rate (%)
时间窗: up to six months
(Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)
Program Enrollment Rate (%)
时间窗: up to three months
(Number of patients who signed a consent form)/(Number of patients invited to enroll)
次要结局
- Change in Medication Dosage (mg/Day; U/Day)(up to six months)
- Change in A1c Measurement (%)(Day 0 and Day 180)
- Average Age of Participants Who Start Trial (Yrs)(up to three months)
- Race of Participants Who Start the Trial (n)(up to three months)
- Weekly Average of Estimated Glucose Values (EGV) (Average)(up to six months)
- Coaching Participation Rate(up to six months)
- Average Age of Participants Who Complete Trial (Yrs)(up to six months)
- Ethnicity of Participants Who Start the Trial (n)(up to three months)
- Texting With Coaches (Daily Average of Text Messages)(up to six months)