Simplera™ CGM US

The Simplera™ continuous glucose monitoring (CGM) system helps people manage diabetes. CGM is a technology that lets users continuously view glucose values throughout the day, sends alerts for glucose events in a convenient and discreet manner on a mobile device, and shows the effects that diet, exercise, and medication can have on glucose levels.

The Simplera™ CGM uses an inserted Simplera™ sensor with Bluetooth™ wireless technology that converts small amounts of glucose from the interstitial fluid under the skin into an electronic signal. The Simplera™ sensor uses that signal to provide sensor glucose values to the Simplera™ app on a compatible display device.

The Simplera™ app provides alerts based on sensor glucose (SG) levels and contains a user interface for entering data such as insulin, meals, exercise, blood glucose (BG) values, and uploading information to the CareLink™ Personal website. The Simplera™ app is available to download from the Google Play™ store and requires the Simplera™ sensor to function.

The Simplera™ CGM provides information that is used for diabetes management but does not provide any direct therapy. The Simplera™ CGM should only be used with supported mobile devices and operating systems. In order to access the list of the supported mobile devices and operating systems, go to http://medtronicdiabetes.com/Device-Compatibility.

To use the Simplera™ CGM, you will need the Simplera™ sensor as well as this app.

IMPORTANT NOTE: The 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. The Simplera™ system does not require calibration. Blood glucose (BG) readings are required (1) during the first 12 hours of use, (2) if no 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 sensor glucose readings, over-administration of insulin, and possible hypoglycemia. Proper settings and hearing are also 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, which can result in serious injury or death. For complete details see https://www.medtronicdiabetes.com/support/download-library/user-guides and https://bit.ly/SimpleraSafety.

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