Using Dexcom Continuous Glucose Monitoring in real-world settings
Dexcom Continuous Glucose Monitoring System Use in aReal-World, Global Registry
This study tests how well the Dexcom Continuous Glucose Monitoring system works for people with diabetes in everyday settings to help them manage their blood sugar levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | DexCom, Inc. Industry-sponsored |
| Locations | 2 sites (Stockbridge, Georgia and 1 other locations) |
| Trial ID | NCT06483945 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of the Dexcom Continuous Glucose Monitoring (CGM) System in real-world clinical settings to understand its impact on diabetes management. It is a non-randomized, open-label, multi-center registry that collects both retrospective and prospective data on the use of the Dexcom CGM System. Participants will be monitored for their glucose levels and will complete patient-reported outcome assessments to gauge the effectiveness of the device in managing their diabetes.
Who should consider this trial
Good fit: Ideal candidates include individuals with diabetes who meet the indications for the Dexcom CGM System and are willing to comply with study protocols.
Not a fit: Patients who are contraindicated for the Dexcom CGM System will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance diabetes management by providing insights into the real-world effectiveness of continuous glucose monitoring.
How similar studies have performed: Other studies have shown positive outcomes with continuous glucose monitoring systems, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockbridge, Georgia and 1 other locations
- Institute of Endocrinology Diabetes, Health & Hormones — Stockbridge, Georgia, United States (Recruiting)
- Palm Research Center — Las Vegas, Nevada, United States (Recruiting)
Study contacts
- Study coordinator: Stayce Beck, PhD
- Email: PTL1000088@dexcom.com
- Phone: 858 704 2428
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.