Diabetes
Conditions
Brief summary
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
Use Dexcom CGM according to approved commercial use. Evaluate HbA1c over time.
Sponsors
Study design
Eligibility
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"
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluations | Up to 8 years | Evaluate outcomes of CGM use for each diabetes type within a given country |