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SmartGuard Technology:
SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose (SG) values.

SmartGuard technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and Type 2 diabetes mellitus in persons 18 years of age and older requiring insulin.

SmartGuard technology is intended for single patient use and requires a prescription.

Predictive Low Glucose Technology:
Predictive Low Glucose technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.

Predictive Low Glucose technology suspends and resumes insulin delivery in Manual mode. Manual mode contains a bolus calculator that calculates an insulin dose based on user-entered data.

Predictive Low Glucose technology is intended for the management of type 1 diabetes mellitus in persons 7 years of age and older, and type 2 diabetes mellitus in persons 18 years of age and older requiring insulin.

Predictive Low Glucose technology is intended for single patient use and requires a prescription.

Device Description for SmartGuard Technology

SmartGuard Technology, also referred to as the Advanced Hybrid Closed Loop (AHCL) algorithm, is a software-only interoperable automated glycemic controller (iAGC) intended to adjust basal insulin delivery and perform automatic correction boluses based on user-entered inputs and sensor glucose (SG) values obtained from a compatible integrated continuous glucose monitor (iCGM) or an interoperable Medtronic continuous glucose monitor (CGM). SmartGuard Technology is embedded within the firmware of a compatible alternate controller enabled (ACE) pump, which functions as the host device.

The ACE pump receives SG data from compatible CGM/iCGM devices via Bluetooth Low Energy (BLE) and also collects user inputs through the ACE pump (for pumps that have a screen) or the MiniMed App (for screenless pumps). The AHCL algorithm does not directly communicate with CGMs/iCGMs; instead, the ACE pump transmits CGM/iCGM data and user-entered inputs to the AHCL algorithm and receives the algorithm's output commands.

In SmartGuard Mode, the AHCL algorithm uses adaptive control to adjust insulin delivery every five (5) minutes based on SG values. It delivers an auto basal insulin dose to maintain user-selectable targets of 100, 110, or 120 mg/dL, supports a temporary target of 150 mg/dL for up to 24 hours, and can automatically deliver correction boluses when appropriate.

Meal boluses are the responsibility of the user. The AHCL algorithm includes an integrated bolus calculator that determines user-initiated meal bolus doses based on available SG information, carbohydrate input, and other patient parameters.

The AHCL algorithm is a software-only device with no user interface. All therapy settings, user interactions, and AHCL-related alerts or alarms are managed through the compatible ACE pump or the MiniMed App. An optional App Manager device with the MiniMed App pre-installed is available as an alternative to a user's personal mobile device.

Device Description for Predictive Low Glucose Technology

Predictive Low Glucose Technology, also referred to as the Predictive Low Glucose Management (PLGM) algorithm, is a software-only interoperable automated glycemic controller (iAGC) that is intended to automatically suspend delivery of insulin when sensor glucose (SG) values fall below or are predicted to fall below predefined threshold values based on user-entered inputs. The PLGM algorithm is embedded within the firmware of a compatible alternate controller enabled (ACE) pump, which functions as the host device.

The ACE pump receives SG data from a compatible integrated continuous glucose monitor (iCGM) or interoperable Medtronic CGM via Bluetooth Low Energy (BLE) and collects user-entered inputs through the ACE pump (for pumps that have a screen) or the MiniMed App (for screenless pumps). The PLGM algorithm does not directly communicate with CGM/iCGM devices; instead, the ACE pump transmits CGM/iCGM data and user inputs to the algorithm and receives the resulting suspend and resume commands. PLGM functionality is available only in Manual mode. In this mode, users are responsible for all basal and bolus insulin delivery, including user-defined basal rate patterns and user-initiated boluses, with optional use of the bolus calculator and the max bolus limit feature. When enabled, the PLGM algorithm may suspend insulin delivery for a minimum of 30 minutes and up to 2 hours based on current or predicted SG values and will automatically resume delivery when criteria are met or when the maximum suspend duration is reached. Users may also manually resume delivery at any time.

The PLGM algorithm is a software-only device with no user interface. All therapy settings, user interactions, and PLGM-related alerts or alarms are managed through the compatible ACE pump or the MiniMed App. An optional App Manager device with the MiniMed App pre-installed is available as an alternative to a user's personal mobile device.

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