Dexcom Continuous Glucose Monitoring System Use in aReal-World, Global Registry (Dexcom Global Registry)
Recruiting now
Conditions studied: Diabetes
In brief
"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"
Key facts
- Study ID
- NCT06483945
- Run by
- DexCom, Inc.
- People needed
- 5000
- Starts
- 2024-02-28
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2024-07-03
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Institute of Endocrinology Diabetes, Health & Hormones — Stockbridge, Georgia, United States (enrolling)
- Palm Research Center — Las Vegas, Nevada, United States (enrolling)
Full record on ClinicalTrials.gov
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