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Recruiting NCT06483945

Dexcom Continuous Glucose Monitoring System Use in aReal-World, Global Registry (Dexcom Global Registry)

Trial Parameters

Condition Diabetes
Sponsor DexCom, Inc.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 5,000
Sex ALL
Min Age 2 Years
Max Age N/A
Start Date 2024-02-28
Completion 2028-03-31
Interventions
Dexcom CGM G6/G6 Pro/G7

Brief Summary

"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"

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Is contraindicated for a Dexcom CGM System per approved commercial labelin

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