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

August 31, 2026 updated by: DexCom, Inc.

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

"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"

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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."

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Institute of Endocrinology Diabetes, Health & Hormones
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The clinical study population will consist of up to 5000 subjects.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcomes (PROs)
Time Frame: 4 years
Patients will be asked to complete multiple questionnaires over a period of 4 years for data to be analyzed and reported.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DexCom, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2024

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTL-1000088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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