NCT07681024尚未招募不适用
Global Long-term Outcomes and Real-World Evaluation of Dexcom Continuous Glucose Monitoring System (Dexcom GLOW)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- DexCom, Inc.
- 入组人数
- 5,000
- 主要终点
- Evaluations
研究概览
简要总结
Global Registry study
详细描述
Global registry study to evaluate Dexcom CGM when used according to approved commercial labeling during standard clinical use across the globe.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets Dexcom CGM System Indications for Use (IFU) per approved commercial labeling
- •2. Has at least one HbA1C (Hemoglobin a1c) measurement obtained within the three (3) months prior to the start date of first Dexcom CGM System use in the study (blinded or unblinded, whichever first). For participants with prior CGM experience (CGM non-naive), this HbA1c measurement must also be at least three (3) months after the end of any CGM usewithin three (3) months prior to the Dexcom CGM System use start date that is at least three (3) months after any prior CGM use
- •3. Participant is willing and able to use Dexcom CGM System according to approved product labeling
- •4. Participant is willing and able to complete applicable patient reported outcome assessments/ surveys
- •5. Participant is willing and able to comply with the Clinical Investigation Plan
- •6. Participant is willing and able to comply with provider requirements for at least one or more provider encounters after CGM initiation according to applicable clinical practice guidelines
- •7. Participant or the participant's legally authorized representative must provide written informed consent prior to any study-related data collection or be enrolled under an IRB/EC/REB approved waiver of consent"
排除标准
- •Is contraindicated for a Dexcom CGM System per approved commercial labeling
- •2. In the Investigator's opinion, the participant is not considered to be a suitable candidate
- •3. Currently participating in another study and receiving and intervention study"
结局指标
主要结局
Evaluations
时间窗: Up to 8 years
Evaluate outcomes of CGM use for each diabetes type within a given country
次要结局
未报告次要终点
研究者
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