Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management
试验速览
- 阶段
- 不适用
- 发起方
- DexCom, Inc.
- 入组人数
- 1,388
- 试验地点
- 25
- 主要终点
- Change in hypoglycemic events
研究概览
简要总结
Evaluate safety of non-adjunctive CGM use in CGM naive participants.
详细描述
The study comprises recruitment and consenting of pediatric and adult participants. At entry, the following information will be collected: demographics, labs, clinical and diabetes history information (history of mild/severe hypoglycemia or DKA events in the past 6 months and SMBG testing frequency). There are 3 clinic visits: Study Entry, Month 6 and Month 12 . Monthly phone contacts will be made to assess for any mild/severe hypoglycemic or DKA events and any details surrounding an event. Clinic visits at Months 6 and 12 will capture frequency of SMBG testing, A1C level and PRO information. CGM data will be obtained during the study to assess for CGM adherence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Naïve to real-time CGM
- •Type 1 or insulin-requiring Type 2 diabetes
- •≥ 2 years old
排除标准
- •Use of RT-CGM, within the past 12 months
- •Pregnancy
- •Concomitant disease or condition that may compromise patient safety including and not limited to severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits, or ongoing treatment for a significant malignancy.
- •Known (or suspected) significant allergy to medical grade adhesives
结局指标
主要结局
Change in hypoglycemic events
时间窗: 6 months
Change in average number of hypoglycemic events per patient between CGM use compared to BGM use
次要结局
- Change in A1C(6 months)
- Change in incidence of hypoglycemic events(6 months)
- Change in Hypoglycemia Confidence PRO scores(6 months)
- Change in GMSS PRO scores(6 months)
- Change in Diabetes Distress Scale (DDS) PRO scores(6 months)
- Change in Hypoglycemia Fear PRO scores(6 months)