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

Dexcom

Status: Enrolling

Conditions: Diabetes

Treatments: Device: Dexcom CGM G6/G6 Pro/G7

Study type: Observational

Funder types: Industry

Identifiers

NCT06483945

PTL-1000088

Details and patient eligibility

About

"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"

Full description

"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."

Enrollment: 5,000 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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 labeling
• In the Investigator's opinion, the subject is not considered to be a suitable candidate