The InPen system, consisting of a mobile app and home-use reusable pen injector, requires a prescription. It is for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin.

The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

The InPen system dose calculator, a component of the InPen system app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.

For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use.

For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use.

For additional product and important safety considerations, see User Guide and https://bit.ly/InPenSafety.

The Simplera™ System requires a prescription. It consists of a sensor and mobile app that perform real-time continuous glucose monitoring (CGM) for the management of diabetes in adults ages 18 years and older. The sensor is indicated for up to 6 days of use, plus an additional grace period of 24 hours. It is intended for use in home environments. 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.

The Simplera™ app in combination with the Simplera™ sensor is intended for use only by patients and caregivers using a compatible mobile device and operating system, and who have sufficient experience to adjust mobile device audio and notification settings. When taking any of the following medications, consult a healthcare professional prior to using the system, as these can bias sensor glucose readings, potentially leading to the over-administration of insulin and a higher risk of hypoglycemia: acetaminophen, paracetamol, hydroxyurea, hydroxycarbamide. 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, consult the user guide at https://www.medtronicdiabetes.com/support/download-library/user-guides and https://bit.ly/InPenSafety.