Not yet recruiting NCT07681024
Global Long-term Outcomes and Real-World Evaluation of Dexcom Continuous Glucose Monitoring System (Dexcom GLOW)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexcom CGM (Continuous Glucose Monitor).
- Who it may be relevant to
- Registry conditions: Diabetes. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Global Registry study
Detailed description
Global registry study to evaluate Dexcom CGM when used according to approved commercial labeling during standard clinical use across the globe.
Interventions
- Device Dexcom CGM (Continuous Glucose Monitor)
Use Dexcom CGM according to approved commercial use. Evaluate HbA1c over time.
Primary outcome measures
- Evaluations [Time frame: Up to 8 years]
Eligibility criteria
Inclusion criteria
- "1. Meets Dexcom CGM System Indications for Use (IFU) per approved commercial labeling
- 2\. Has at least one HbA1C (Hemoglobin a1c) measurement obtained within the three (3) months prior to the start date of first Dexcom CGM System use in the study (blinded or unblinded, whichever first). For participants with prior CGM experience (CGM non-naive), this HbA1c measurement must also be at least three (3) months after the end of any CGM usewithin three (3) months prior to the Dexcom CGM System use start date that is at least three (3) months after any prior CGM use
- 3\. Participant is willing and able to use Dexcom CGM System according to approved product labeling
- 4\. Participant is willing and able to complete applicable patient reported outcome assessments/ surveys
- 5\. Participant is willing and able to comply with the Clinical Investigation Plan
- 6\. Participant is willing and able to comply with provider requirements for at least one or more provider encounters after CGM initiation according to applicable clinical practice guidelines
- 7\. Participant or the participant's legally authorized representative must provide written informed consent prior to any study-related data collection or be enrolled under an IRB/EC/REB approved waiver of consent"
Exclusion criteria
- "1. Is contraindicated for a Dexcom CGM System per approved commercial labeling
- 2\. In the Investigator's opinion, the participant is not considered to be a suitable candidate
- 3\. Currently participating in another study and receiving and intervention study"
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07681024 · PTL-1000728