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Recruiting

NCT Number: NCT06483945

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

Recruiting

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Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Endocrinology Diabetes, Health & Hormones, Stockbridge, Georgia, United States

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About this study

"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."

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexcom CGM G6/G6 Pro/G7

Device

Dexcom CGM G6/G6 Pro/G7 device

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen Hurst

CONTACT

[email protected]

858 704 2428

Stayce Beck, PhD

CONTACT

[email protected]

858 704 2428

Sponsors and collaborators

Lead sponsor

DexCom, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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