Simplera™ CGM is now FDA-approved!
Simplera™ CGM is for people who manage their diabetes with insulin injections.
Here are some of the new features that will be available:
- A simple, two-step insertion process
- A disposable inserter
- No overtape required
- Designed to replace fingersticks*
* Fingersticks required during first 12 hours of use, when taking paracetamol or acetaminophen (found in certain cold medicines), when most recent sensor glucose readings are not available, or when symptoms do not match sensor glucose values
Important safety information: Simplera™ SystemThe Simplera™ System requires a prescription and is indicated for the management of diabetes in persons ages 18 years and older. The sensor is indicated for up to 6 days of use plus an additional 24-hour grace period. Blood glucose (BG) readings are needed (1) during the first 12 hours of use, (2) if not sensor data is available, (3) when symptoms do not match the sensor glucose (SG) value, and (4) when taking certain medications. Not taking BG readings as indicated can lead to incorrect SG readings, over-administration of insulin, and possible hypoglycemia. Proper settings and hearing are required. Sensor use can also result in skin irritation, bruising, discomfort, redness, bleeding, and infection, and sensors in general also pose a choking risk to young children. For complete details see https://www.medtronicdiabetes.com/support/download-library/user-guides and https://bit.ly/SimpleraSafety.