Dexcom Continuous Glucose Monitoring System Use in aReal-World, Global Registry (Dexcom Global Registry)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexcom CGM G6/G6 Pro/G7.
- Who it may be relevant to
- Registry conditions: Diabetes. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dexcom Continuous Glucose Monitoring System Use in aReal-World, Global Registry
Overview
"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
- Device Dexcom CGM G6/G6 Pro/G7
Dexcom CGM G6/G6 Pro/G7 device
Primary outcome measures
- Patient Reported Outcomes (PROs) [Time frame: 4 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Institute of Endocrinology Diabetes, Health & Hormones — Stockbridge
- Palm Research Center — Las Vegas
Identifiers
NCT: NCT06483945 · PTL-1000088