NCT06483945进行中（未招募）不适用
Dexcom Continuous Glucose Monitoring System Use in aReal-World, Global Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- DexCom, Inc.
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Patient Reported Outcomes (PROs)
研究概览
简要总结
"To evaluate the use of the Dexcom CGM System when used according to approved commercial labeling during standard clinical use and its impact on intended users in a real-world setting"
详细描述
"The Dexcom Global Registry is a non-randomized, open-label, multi-center registry with the goal of collecting Dexcom CGM System data in a real world setting.The registry study involves retrospective and/or prospective data collection associated with Dexcom CGM System use."
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
- 是
入选标准
- •Meets Dexcom CGM System Indications for Use (IFU) per approved commercial labeling
- •Has at least one HbA1C (Hemoglobin a1c) measurement within three (3) months prior to the Dexcom CGM System use start date that is at least three (3) months after any prior CGM use
- •Subject is willing and able to use Dexcom CGM System according to approved product labeling
- •Subject is willing and able to complete applicable patient reported outcome assessments/ surveys
- •Subject is willing and able to comply with the protocol
- •Subject is willing and able to comply with provider requirements for at least two provider encounters per year according to applicable clinical practice guidelines
- •Subject or the subject's legally authorized representative must provide written informed consent prior to any study-related data collection or be enrolled under an IRB/EC approved waiver of consent
排除标准
- •Is contraindicated for a Dexcom CGM System per approved commercial labeling
- •In the Investigator's opinion, the subject is not considered to be a suitable candidate
结局指标
主要结局
Patient Reported Outcomes (PROs)
时间窗: 4 years
Patients will be asked to complete multiple questionnaires over a period of 4 years for data to be analyzed and reported.
次要结局
未报告次要终点
研究者
研究点 (2)
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