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The Eversense 365 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to 1 year in people (18 years or older) with diabetes. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions. The system is intended to: · Provide real-time glucose readings. · Provide glucose trend information. · Provide alerts for the detection of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia). Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time. The Eversense 365 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Eversense 365 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes. The system is intended for single patient use and requires a prescription.

The Eversense 365 Continuous Glucose Monitoring (CGM) System provides continuous glucose measurements over a 40-400 mg/dL range. The system calculates glucose, trends and provides alerts for high and low glucose available for display on a mobile platform. It consists of a glucose Sensor (the Eversense 365 Sensor) that is inserted under the skin using Insertion Tools; an externally worn Eversense 365 Smart Transmitter); and the Eversense 365 App, which runs on a compatible handheld device (HHD), such as a smartphone. The inserted Sensor is a radiofrequency (RF)-powered device that collects readings and sends them to the Transmitter. The Transmitter calculates, stores, and transmits the glucose data via Bluetooth Low Energy (BLE) to the Eversense 365 App on an HHD. The CGM System consists of three principal components. - 1. Sensor: The Sensor, inserted subcutaneously, receives RF-power from the Transmitter to measure interstitial fluid glucose every 5 minutes. The Sensor sends fluorescence readings or data to the Transmitter for calculation and storage of glucose values. The Sensor has a silicone collar component that contains an anti-inflammatory steroid drug (dexamethasone acetate) that elutes locally to reduce tissue inflammation around the Sensor. The Sensor operating life is up to one year or until the device's end-of-life is reached, whichever occurs first. The Sensor is provided sterile, for single use in a Sensor Holder. The Sensor is inserted using the provided Insertion Tools. - 2. Transmitter: The Transmitter, worn externally over the inserted Sensor, is a device with rechargeable battery that powers the Sensor, calculates the glucose values from the Sensor-measured fluorescence readings, and using secure BLE wirelessly sends the glucose information to the Eversense 365 App for display on the HHD. An adhesive patch holds the Transmitter in place. The Transmitter is charged using the provided power cord and charge adapter. The Transmitter also provides vibration signals for alerts and notifications, such as low glucose levels, irrespective of whether the Eversense 365 App is in the vicinity or not. - 3. App: The Eversense 365 App is a software application that runs on an HHD (e.g., compatible mobile device) for display of glucose information provided by the Transmitter. The Eversense 365 App receives and displays the calculated glucose information from the Transmitter, including glucose trend information and glucose alerts. The Eversense 365 App also allows the user to calibrate the CGM System. It also communicates with the Senseonics server for a one-time download of calibration parameters specific for each Sensor following the insertion as part of the linking process. The Eversense 365 App also provides the user an option to upload the data to Senseonics Data Management System (DMS) for historic viewing and storing of glucose data.

The Eversense AP CGM System is indicated for continually measuring glucose levels for up to 6 months in people (18 years and older) with diabetes. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions. The system is intended to: · Provide real-time glucose readings. - · Provide glucose trend information. · Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia). Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns and trends seen over time. The Eversense AP CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Eversense AP CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes. The system is intended for single patient use and requires a prescription.

The Eversense AP CGM System is a continuous glucose monitoring system (CGM) that provides glucose measurements every 5 minutes over a 40-400 mg/dL range. The system calculates glucose, trends and provides alerts for high and low glucose available for display on a mobile platform. It consists of a glucose sensor (the Eversense AP Sensor) that is inserted by a healthcare provider under the skin using Insertion Tools; an externally worn Eversense AP Smart Transmitter (Transmitter); and the Eversense Mobile Medical Application (MMA), which runs on a handheld device, such as a smartphone running on Android or iOS operating systems. The inserted sensor is a radiofrequency (RF)-powered device that collects readings and sends them to the Transmitter. The Transmitter calculates, stores, and transmits the glucose data via Bluetooth Low Energy (BLE) to an MMA on a handheld device (HHD). The Eversense AP CGM System can communicate glucose readings and other information wirelessly and securely to and from interoperable electronic interfaces: including compatible AID systems. The Eversense AP CGM System is designed to communicate with interoperable devices in several ways, such as described below: - · Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol. - · The app communicates through the cloud to another software device.