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The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (Dexcom G7 15 Day CGM System or G7 15 Day) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 18 years and older. The Dexcom G7 15 Day CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 15 Day CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 15 Day CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G7 15 Day CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 15 Day CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (Dexcom G7 15 Day CGM System or G7 15 Day) is an interoperable continuous glucose monitoring system intended to continuously measure the glucose in the interstitial fluid, calculate the glucose reading and make this available to the user. The Dexcom G7 15 Day CGM System is intended for single patient use at home and requires a prescription. The G7 15 Day consists of the following primary components: a wearable, consisting of a sensor and transmitter worn on the body and a display device, which can be a G7 Mobile Application (Mobile App) on an iOS or Android OS smart device or a G7 Receiver (Receiver). To achieve the intended functions and performance of the G7 15 Day, one sensor and at least one display device (App or Receiver) must be used together. The user must pair the display device(s) with each unique sensor to enable communication and start a sensor session. During an active session, the sensor reports new glucose data to the display device every 5-minutes. The display device then displays glucose data and provides alerts and information signals to the user. The reportable glucose range for the G7 15 Day is 40 mg/dL to 400 mg/Dl. Glucose values below this range are reported as 'LOW' and glucose values above this range are reported as 'HIGH'. The sensor has an expected wear period of up to 15 days with an extended 12-hour grace period after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time. The Dexcom G7 15 Day CGM System is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely to and from compatible electronic interfaces via the following secure wireless connections: - Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol - The Mobile App communicates to another app on a single mobile platform - The Mobile App communicates through the cloud to another software device - Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable secure and reliable communication of CGM data to authorized client software intended to receive the data through the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID). Principle of Operation: The principles of operation for the Dexcom G7 15 Day CGM System remain the same as prior generations of Dexcom CGM Systems. The System uses a wire-type sensing mechanism that continuously measures interstitial glucose levels and uses a radio transmitter to wirelessly communicate glucose data to the display device for the user to see and use accordingly.

Libre 2 Sensor users: The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. Libre 2 Plus Sensor users: The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes. Libre 3 Sensor users: The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices. The System can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. Libre 3 Plus Sensor users: The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

The FreeStyle Libre 3 Continuous Glucose Monitoring System (hereinafter also referred to as 'FSL3 System') and FreeStyle Libre 2 Flash Glucose Monitoring System (hereinafter also referred to as the 'FSL2 System') are integrated continuous glucose monitoring (iCGM) systems that provide continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The FSL2 and FSL3 Systems also provide configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss. The user may make treatment decisions based in part on the sensor glucose results provided by both Systems. The FSL2 and FSL3 Systems require a prescription and are intended for home use. The subject FSL3 System consists of a sensor (the FreeStyle Libre 3 Sensor (FSL3 Sensor) or FreeStyle Libre 3 Plus Sensor (FSL3 Plus Sensor)) and a primary display device (the FreeStyle Libre 3 Reader (FSL3 Reader) or the FreeStyle Libre App (FSL App) [iOS and Android] downloaded to a compatible phone). The FSL3 Reader and the FSL App do not interact with each other. The subject FSL2 System consists of a sensor (the FreeStyle Libre 2 Sensor (FSL2 Sensor) or FreeStyle Libre 2 Plus Sensor (FSL2 Plus Sensor)) and a primary display device (the FreeStyle Libre 2 Reader (FSL2 Reader) or the FSL App (iOS and Android) downloaded to a compatible phone). The FSL2 Reader and FSL App do not interact with each other. Both the FSL2 and FSL3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FSL2 or FSL3 Systems, which directly receives the data from the sensor, continues to serve as a primary display device for the glucose data and alarms.

The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older. The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypodlycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

The Dexcom G7 Continuous Glucose Monitoring System) is an interoperable continuous glucose monitoring (CGM) system intended to continuously measure the interstitial fluid, calculate the qucose reading and make this available to the user. The G7 System is intended for single patient use at home and requires a prescription. The G7 System comprises the following primary components: a wearable, consisting of a G7 sensor and transmitter worn on the body and a display device, which can be a G7 Mobile App) on an iOS or Android OS smart device, or a G7 Receiver (Receiver). To achieve the intended functions and performance of the G7 System, one sensor and at least one display device (App or Receiver) must be used together. The user must pair the display device(s) with each unique sensor to enable communication and start a sensor session. During an active session, the sensor reports new glucose data to the display device every 5-minutes. The displays glucose data and provides alerts and information signals to the user. The reportable glucose range for the G7 System is 40 mg/dL to 400 mg/dL. Glucose values below this range are reported as 'LOW' and glucose values above this range are reported as 'HIGH'. The sensor has an expected wear period of up to 10 days with an extended 12-hour grace period after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time. The G7 is an interoperable connected device that can communicate glucose readings and other information wirelessly and securely to and from compatible electronic interfaces via the following secure wireless connections: • Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol · The Mobile App communicates to another app on a single mobile platform · The Mobile App communicates through the cloud to another software device o Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable secure and reliable communication of CGM data to authorized client software intended to receive the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID). Principle of Operation: The principles of operation for the Dexcom G7 System renain the same as prior generations of Dexcom CGM System uses a wire-type sensing mechanism that continuously measures interstitial glucose levels and uses a radio transmitter to wirelessly communicate glucose data to the display device for the user to see and use accordingly.

The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a real time, continuous qlucose monitoring device indicated for the management of diabetes in persons 2 years and older. The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypodlycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

The Dexcom G7 Continuous Glucose Monitoring System (G7 System) is an interoperable continuous glucose monitoring (CGM) system intended to continuously measure the glucose in the interstitial fluid, calculate the glucose reading and make this available to the user.The G7 System is intended for single patient use at home and requires a prescription. The G7 System comprises the following primary components: a wearable, consisting of a G7 sensor and transmitter worn on the body and a display device, which can be a G7 Mobile App) on an iOS or Android OS smart device, or a G7 Receiver (Receiver). The proposed G7 CGM System is modified to allow users to display glucose data directly from the transmitter on compatible iOS smartwatches. To achieve the intended functions and performance of the G7 System, one sensor and at least one display device (App or Receiver) must be used together. The user must pair the display device(s) with each unique sensor to enable communication and start a sensor session. During an active session, the sensor reports new glucose data to the display device every 5-minutes. The displays glucose data and provides alerts and information signals to the user. The reportable glucose range for the G7 System is 40 mg/dL to 400 mg/dL. Glucose values below this range are reported as 'LOW' and glucose values above this range are reported as 'HIGH'. The sensor has an expected wear period of up to 10 days with an extended 12-hour grace period after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time. The G7 is an interoperable connected device that can communicate glucose readings and other information wirelessy and securely to and from compatible electronic interfaces via the following secure wireless connections: - · Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol - · The Mobile App communicates to another app on a single mobile platform - · The Mobile App communicates through the cloud to another software device o Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable secure and reliable communication of CGM data to authorized client software intended to receive the data through the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID). Principle of Operation: The principles of operation for the Dexcom G7 System renain the same as prior generations of Dexcom CGM System uses a wire-type sensing mechanism that continuously measures interstitial glucose levels and uses a radio transmitter to wirelessly communicate glucose data to the display device for the user to see and use accordingly.

The Dexcom G7 Continuous Glucose Monitoring (CGM) System is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older. The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purposes of managing diabetes.

The Dexcom G7 Continuous Glucose Monitoring System) is an interoperable connected device that measures and displays estimated dlucose values for people with diabetes. The G7 System consists of the following components: the Glucose Sensing Subsystem (GSS), the Mobile Application Subsystem (MAS), the Receiver Subsystem (RVS), The GSS is comprised of the sensor applicator and on-body wearable, which includes a Bluetooth Low Energy (BLE) transmitter, adhesive patch and sensor. The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The sensor has an expected wear period of up to 10 days with an extended 12-hour grace period after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time. The transmitter is pre-connected to the sensor and is cradled into the applicator needle inside the applicator housing. The applicator external housing consists of a cap and shroud which utilize a threaded cap and seal to create the sterile barrier system. A deployment lock mechanism prevents insertion of the on-body wearable until the applicator is pressed against the insertion site. The insertion is then completed with a single button press vertical spring deployed mechanism, which introduces the sensor via the subcutaneous tissue while also placing the embedded wearable onto the body. The wearable adheres to the skin via an adhesive patch. After deployment, the transmitter initiates automatic wakeup and session start. The sensor's small and flexible wire converts qlucose to electrical current and the transmitter samples the electrical current produced by the sensor. The transmitter's onboard algorithm converts these measurements into estimated qlucose values and calculates the glucose rate of change; the data are sent every 5 minutes to the MAS and/or the RVS. The MAS and RVS are display devices that present the current ducose reading and glucose trend to the user. Both display devices alert the user when glucose levels are outside of a target zone and when specific system states occur. The G7 System is designed to communicate to one or both display devices simultaneously. The G7 System is also designed to communicate estimated glucose values, trend and system information to other compatible electronic interfaces via the following secure wireless connections: - . Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol - . The app communicates to another app on a single mobile platform - The app communicates through the cloud to another software device ● - Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable secure and o reliable communication of CGM data to authorized client software intended to receive the data through the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID). The proposed G7 CGM System uses the same mode of operation and mechanism of reaction as the predicate G7 CGM System (K213919). The proposed G7 CGM System uses an alternate GSS wearable adhesive.

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes. The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

The FreeStyle Libre 3 Continuous Glucose Monitoring System (hereinafter also referred to as 'FSL3 System') and FreeStyle Libre 2 Flash Glucose Monitoring System (hereinafter also referred to as the 'FSL2 System') are integrated continuous glucose monitoring (iCGM) systems that provide continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The FSL2 and FSL3 Systems also provide configurable alarms designed to warn the user of Low Glucose, High Glucose or Signal Loss. The user may make treatment decisions based in part on the Sensor glucose results provided by both Systems. The FSL2 and FSL3 Systems require a prescription and are intended for home use. The FSL3 System consists of the FreeStyle Libre 3 Sensor and either the FreeStyle Libre 3 Reader or the FreeStyle Libre 3 App (iOS and Android) downloaded to a compatible smartphone as a primary display device. The FSL3 Reader and FSL3 App do not interact with each other. The FSL2 System consists of the FreeStyle Libre 2 Sensor and either the FreeStyle Libre 2 Reader or the FreeStyle Libre 2 App (iOS and Android) downloaded to a compatible smartphone as a primary display device. The FSL2 Reader and FSL2 App do not interact with each other. Both the FSL2 and FSL3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FSL2 or FSL3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms.

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes. The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes.

The FreeStyle Libre 2 Flash Glucose Monitoring System (with modified Sensor tail), hereinafter also referred to as 'modified FSL2 System' and FreeStyle Libre 3 Continuous Glucose Monitoring System (with modified Sensor tail), hereinafter also referred to as 'modified FSL3 System' are integrated continuous glucose monitoring (iCGM) systems that provide continuous glucose measurements every minute to provide glucose levels, trends, and real-time alarms capability to aid in the management of diabetes. The Systems also provide configurable alarms designed to warn the user of Low Glucose or Signal Loss. The user may make treatment decisions based in part on the Sensor glucose results provided by the Systems require a prescription and are intended for home use. The FreeStyle Libre 2 System consists of the FreeStyle Libre 2 Sensor and either the FreeStyle Libre 2 Reader or the FreeStyle Libre 2 App downloaded to a compatible smartphone as a primary display device. The FreeStyle Libre 3 System consists of the FreeStyle Libre 3 Sensor and the FreeStyle Libre 3 App downloaded to a compatible smartphone as a primary display device. Both the FreeStyle Libre 2 and FreeStyle Libre 3 Systems are compatible with the Libre Data Sharing API cleared in K223537. The display device of the connected FreeStyle Libre 2 or FreeStyle Libre 3 Systems, which directly receives the data from the Sensor, continues to serve as a primary display device for the glucose data and alarms.

The Dexcom G6 Continuous Glucose Monitoring System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and sequential readings over time. The Dexcom G6 System also aids in the detection of evisodes of hyperglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

The proposed Dexcom G6 CGM System is based on the same physical principles and fundamental design as the predicate but includes an alternative receiver. This receiver has identical hardware to the G7 receiver (K213919). The Dexcom G6 CGM System is designed to function as intended with either the proposed or current commercial receiver. The proposed receiver has the same function as the commercial receiver. The Dexcom G6 Continuous Glucose Monitoring System is an interoperable connected device that measures and displays glucose values for patients with diabetes. The G6 CGM System consists of three main components: a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled display device (receiver and/or mobile application). The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts ducose into electrical current. The sensor has an expected wear time of up to 10 days. The transmitter is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the receiver and/or mobile app, which displays the current qlucose reading (updated every 5 minutes) and glucose trends. The receiver and/or mobile app also alerts the user when glucose levels are outside of a target zone and when other important system conditions occur. The G6 CGM System is designed to be used alone or in conjunction with digitally connected devices. The G6 CGM System can communicate Estimated Glucose Values (EGV) and other information wirelessly and securely to and from these digitally connected devices.

The Dexcom G7 Continuous Glucose Monitoring (CGM) System is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older. The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on the glucose trends and sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purposes of managing diabetes.

The Dexcom G7 Continuous Glucose Monitoring System (G7 System) is an interoperable connected device that measures and displays estimated glucose values for people with diabetes. The G7 System consists of the following components: the Glucose Sensing Subsystem (GSS), the Mobile Application Subsystem (MAS), the Receiver Subsystem (RVS). The GSS is comprised of the sensor applicator and on-body wearable, which includes a Bluetooth Low Energy (BLE) molded transmitter, adhesive patch and sensor. The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The sensor has an expected wear period of up to 10 days with an extended 12-hour grace period after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time. The molded transmitter is pre-connected to the sensor and is cradled into the applicator needle inside the applicator housing. The applicator external housing consists of a cap and shroud which utilize a threaded cap and seal to create the sterile barrier system. A deployment lock mechanism prevents insertion of the on-body wearable until the applicator is pressed against the insertion site. The insertion is a single button press vertical spring deployed mechanism which introduces the sensor via the needle into the subcutaneous tissue, while also placing the embedded wearable onto the body which adheres to the skin via an adhesive patch. After deployment, the molded transmitter initiates automatic wakeup and session start. The sensor's small and flexible wire converts glucose to electrical current and the transmitter samples the electrical current produced by the sensor. The transmitter's onboard algorithm converts these measurements into estimated glucose values and calculates the glucose rate of change which are sent every 5 minutes to the MAS and/or the RVS. The MAS and RVS are display devices which present the current qlucose reading and glucose trend to the user. Both display devices alert the user when glucose levels are outside of a target zone and when specific system states occur. The G7 System is designed to communicate to one or both display devices simultaneously. The G7 System is also designed to communicate estimated glucose values, trend and system information to other compatible electronic interfaces via the following secure wireless connections: - Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol - . The app communicates to another app on a single mobile platform - . The app communicates through the cloud to another software device. - Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable o secure and reliable communication of CGM data to authorized client software intended to receive the data through the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).

The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoqlycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes. The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older. The Dexcom Glucose Program System is intended to replace fingerstick blood ducose testing for diabetes treatment decisions for persons with diabetes who are not at significant risk of severe hypoglycemia. Interpretation of the Dexcom Glucose Program System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes. The Dexcom G6 Professional Continuous Glucose Monitoring System (Dexcom G6 Pro System) is a real time continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. The Dexcom G6 Pro System is intended to replace fingerstick blood qlucose testing for diabetes treatment decisions. Interpretation of the real-time Dexcom G6 Pro System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 Pro System may also be used as a retrospective glucose recording device indicated for assessing glycemic variability in persons age 2 years and older in a home environment while under the supervision of a healthcare professional. Retrospective interpretation of data recorded by the Dexcom G6 Pro System should be conducted solely by a healthcare professional. The Dexcom G6 Pro System aids in detecting glucose excursions facilitating care plan adjustments. The Dexcom G6 Pro System is also intended to interface with digitally connected devices. The Dexcom G6 Pro System can be used alone or in coniunction with these digitally connected medical devices for managing diabetes or assessing glycemic variability.

The proposed Dexcom G6 CGM System, Dexcom G6 Glucose Program CGM System, and Dexcom G6 Professional CGM System are based on the same physical principles and fundamental design as the predicate for each respective system but includes a modified adhesive patch. The adhesive patch adheres the transmitter holder to the user's body. The Dexcom G6 CGM System, Dexcom G6 Glucose Program CGM System, and the Dexcom G6 Professional CGM System are designed to function as intended with either the proposed or current adhesive patch. The proposed adhesive patch has the same form, fit, and function as the commercial adhesive patch and, from the users' perspective, functions identically. Dexcom G6 CGM System: The Dexcom G6 Continuous Glucose Monitoring System is an interoperable connected device that measures and displays glucose values for patients with diabetes. The G6 CGM System consists of three main components: a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a BLE enabled display device (receiver and/or mobile application). The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The sensor has an expected wear time of up to 10 days. The transmitter is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the receiver and/or mobile app, which displays the current glucose reading (updated every 5 minutes) and glucose trends. The receiver and/or mobile app also alerts the user when glucose levels are outside of a target zone and when other important system conditions occur. The G6 CGM System is designed to be used alone or in conjunction with digitally connected devices. The G6 CGM System can communicate Estimated Glucose Values (EGV) and other information wirelessly and securely to and from these digitally connected devices. Dexcom G6 Glucose Program CGM System: The Dexcom G6 Glucose Program Continuous Glucose Monitoring System measures and displays glucose values and trends for patients with diabetes who are not at significant risk of severe hypoglycemia. The system is factory calibrated and provides continuous qlucose readings at five-minute intervals for up to ten days of use. The system consists of a sensor/applicator, a Bluetooth Low Energy (BLE) transmitter, and a mobile CGM software module (app module) that is embedded within a third-party program provider's mobile app (host app). The sensor is a small and flexible wire, which is inserted by the applicator into subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. The transmitter samples the electrical current produced by the sensor and converts these measurements into estimated glucose values (EGV) using an onboard algorithm. The transmitter sends glucose data to the app module, which displays the current glucose reading (updated every 5 minutes) and glucose trends. The app module does not include any glucose related alarm or alerts but will alert the user when important system conditions occur. Dexcom G6 Professional CGM System: The Dexcom G6 Professional CGM System is a continuous glucose monitor that offers an introduction to CGM for users who would benefit from the supervision of their qualified Healthcare Professional (HCP) during early or initial use of CGM. The G6 Professional CGM System consists of three main components: a sensor/applicator delivery system, a transmitter, and a mobile application (app). The sensor is a small and flexible wire inserted into subcutaneous tissue where it converts glucose into electrical current. The G6 Professional CGM System transmitter is connected to the sensor and is worn on the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The G6 Professional CGM System transmitter's firmware includes an auto-start feature which enables the transmitter to start a session immediately upon attachment of the transmitter to the on-body wearable. The G6 Professional CGM System transmitter can be used as a retrospective CGM data logger, and it can also send real-time estimated glucose values to the G6 Mobile Application. The HCP elects which type of CGM session the patient receives (retrospective vs. real-time). The G6 Professional CGM System transmitter firmware supports a single-use 10-day sensor session per transmitter. The G6 Mobile Application displays the current glucose reading (updated every 5 minutes) and qlucose trends (up to 24 hours) from the transmitter.