Dexcom Continuous Glucose Monitoring System Use in aReal-World, Global Registry (Dexcom Global Registry)
1 other identifier
observational
5,000
1 country
2
Brief 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"
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2024
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2024
CompletedFirst Submitted
Initial submission to the registry
March 21, 2024
CompletedFirst Posted
Study publicly available on registry
July 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
July 3, 2024
June 1, 2024
4.1 years
March 21, 2024
June 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Reported Outcomes (PROs)
Patients will be asked to complete multiple questionnaires over a period of 4 years for data to be analyzed and reported.
4 years
Interventions
Dexcom CGM G6/G6 Pro/G7 device
Eligibility Criteria
The clinical study population will consist of up to 5000 subjects.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DexCom, Inc.lead
Study Sites (2)
Institute of Endocrinology Diabetes, Health & Hormones
Stockbridge, Georgia, 30281, United States
Palm Research Center
Las Vegas, Nevada, 89148, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2024
First Posted
July 3, 2024
Study Start
February 28, 2024
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
July 3, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share