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

NCT ID: NCT06483945

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-28

Study Completion Date

2028-06-30

Brief Summary

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"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

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"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."

Conditions

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Dexcom CGM G6/G6 Pro/G7

Dexcom CGM G6/G6 Pro/G7 device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DexCom, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Endocrinology Diabetes, Health & Hormones

Stockbridge, Georgia, United States

Site Status RECRUITING

Palm Research Center

Las Vegas, Nevada, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stayce Beck, PhD

Role: CONTACT

858 704 2428

Kathleen Hurst

Role: CONTACT

858 704 2428

Facility Contacts

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Shehzad Topiwala, MD

Role: primary

Ellen Neylon, MSN

Role: primary

702-736-5161

Other Identifiers

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PTL-1000088

Identifier Type: -

Identifier Source: org_study_id

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