Simplera™ CGM US

The Simplera™ continuous glucose monitoring (CGM) system helps people manage diabetes. CGM is a technology that lets users view glucose values throughout the day, sends alerts for glucose events on a mobile device, and shows the effects life has on glucose levels.

The Simplera™ CGM uses a Simplera™ sensor with Bluetooth™ that converts small amounts of glucose from under the skin into an electronic signal. This signal is used to provide sensor glucose (SG) values to the Simplera™ app on a compatible device.

The Simplera™ app provides alerts based on SG levels and the user can enter data such as insulin, meals, exercise, blood glucose (BG) values, and upload information to CareLink™ Personal. The Simplera™ app requires the Simplera™ sensor to function.

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

The clinical configuration of the app is intended for use in clinical research only. It is available only to individuals who have consented to take part in clinical research activities with Medtronic. Clinical studies where this app will be used will follow their own regulatory process and obtain requisite approvals.

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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This app is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition or treatment.

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