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

Recruiting

• Conditions: Diabetes

• Registration Number: NCT06483945
• Lead Sponsor: DexCom, Inc.

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"

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."

Study Timeline

• Study Start: 2024-02-28
• Study First Submitted: 2024-03-21
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Primary Completion: 2028-03-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient Reported Outcomes (PROs)	4 years	Patients will be asked to complete multiple questionnaires over a period of 4 years for data to be analyzed and reported.

Trial Locations

Locations (2)

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

Palm Research Center; 🇺🇸 Las Vegas, Nevada, United States