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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06483945
Enrollment
5000
Registered
2024-07-03
Start date
2024-02-28
Completion date
2028-06-30
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

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"

Detailed 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."

Interventions

DEVICEDexcom CGM G6/G6 Pro/G7

Dexcom CGM G6/G6 Pro/G7 device

Sponsors

DexCom, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Reported Outcomes (PROs)4 yearsPatients will be asked to complete multiple questionnaires over a period of 4 years for data to be analyzed and reported.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026