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

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

"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"

Study Overview

• Status: Recruiting
• Conditions: Diabetes
• Intervention / Treatment: Device: Dexcom CGM G6/G6 Pro/G7

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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Stayce Beck, PhD; Phone Number: 858 704 2428; Email: PTL1000088@dexcom.com
• Study Contact Backup: Name: Kathleen Hurst; Phone Number: 858 704 2428; Email: PTL1000088@dexcom.com

Study Locations

• United States
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Recruiting
      • Institute of Endocrinology Diabetes, Health & Hormones
      • Contact: Shehzad Topiwala, MD; Email: shehzad.topiwala@iedhh.com
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Recruiting
      • Palm Research Center
      • Contact: Ellen Neylon, MSN; Phone Number: 702-736-5161; Email: neylon@palmresearchcenter.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The clinical study population will consist of up to 5000 subjects.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: DexCom, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PTL-1000088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes