Dexcom Continuous Glucose Monitoring System Use in aReal-World, Global Registry (Dexcom Global Registry)
Purpose
"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"
Condition
- Diabetes
Eligibility
- Eligible Ages
- Over 2 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Institute of Endocrinology Diabetes, Health & Hormones
Stockbridge, Georgia 30281
Stockbridge, Georgia 30281
Palm Research Center
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
More Details
- Status
- Recruiting
- Sponsor
- DexCom, Inc.
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."