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

Last updated: June 28, 2024
Sponsor: DexCom, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Vitreous Hemorrhage

Diabetic Retinopathy

Diabetic Neuropathy

Treatment

Dexcom CGM G6/G6 Pro/G7

Clinical Study ID

NCT06483945
PTL-1000088
  • Ages > 2
  • All Genders
  • Accepts Healthy Volunteers

Study 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"

Eligibility Criteria

Inclusion

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 tothe Dexcom CGM System use start date that is at least three (3) months after anyprior CGM use

  • Subject is willing and able to use Dexcom CGM System according to approved productlabeling

  • Subject is willing and able to complete applicable patient reported outcomeassessments/ surveys

  • Subject is willing and able to comply with the protocol

  • Subject is willing and able to comply with provider requirements for at least twoprovider encounters per year according to applicable clinical practice guidelines

  • Subject or the subject's legally authorized representative must provide writteninformed consent prior to any study-related data collection or be enrolled under anIRB/EC approved waiver of consent

Exclusion

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 suitablecandidate

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: Dexcom CGM G6/G6 Pro/G7
Phase:
Study Start date:
February 28, 2024
Estimated Completion Date:
June 30, 2028

Study 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."

Connect with a study center

  • Institute of Endocrinology Diabetes, Health & Hormones

    Stockbridge, Georgia 30281
    United States

    Active - Recruiting

  • Palm Research Center

    Las Vegas, Nevada 89148
    United States

    Active - Recruiting

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