Our updated InPen™ app is now FDA-cleared!
The new InPen™ app, featuring missed meal dose detection, paves the way for the launch of our latest Smart MDI system with the Simplera™ continuous glucose monitor (CGM).
The Smart MDI system combines the InPen™ smart insulin pen with the new Simplera™ CGM, our first disposable, all-in-one CGM — that’s also half the size of our previous CGMs. The system provides you:
- Real-time personalized insights
- Dosing guidance, such as when and how much insulin to dose
- Recommended corrections for missed or inaccurate mealtime doses
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 SG 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 SG 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. For complete details, consult the user guide at https://www.medtronicdiabetes.com/support/download-library and https://www.medtronicdiabetes.com/important-safety-information#simplera.
Important safety information: InPen™ smart insulin pen
The InPen™ is a home-use reusable pen injector 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 and for calculating an insulin dose or carbohydrate intake based on user entered data. A healthcare professional must assist in dosage programming of the device prior to use, based on various patient-specific criteria and targets. The InPen™ requires a prescription. For additional product and safety information, please consult the Instructions for Use and bit.ly/InPenSafety.