Medtronic has received clearance from the US Food and Drug Administration (FDA) for its new InPen app, paving the way for introducing its Smart multiple daily injection (MDI) system.

The system offers personalised and real-time insights for individuals managing diabetes through MDI therapies.

It combines the company’s InPen smart insulin pen with its Simplera continuous glucose monitor (CGM), a disposable, all-in-one device.

The MDI system is poised to be the first on the market to offer recommendations for correcting missed or inaccurate insulin doses.

For diabetic individuals, taking insulin injections before meals is crucial to maintain glucose levels and prevent post-meal blood sugar spikes. Despite their importance, it is estimated that one out of three doses are missed regularly.

The Smart MDI system's ‘Missed Dose alert’ aims to reduce these occurrences, thereby mitigating the risk of diabetes-related complications.

Medtronic plans to initially roll out the Smart MDI system to existing standalone CGM and InPen customers, with a broader commercial launch to follow.

In September 2023, the company announced the CE mark approval for the Simplera CGM. The no-fingerstick sensor does not require additional tape and is compatible with iOS and Android platforms, designed for individuals aged two years and older.

Using Bluetooth technology, InPen communicates with a mobile app, which assists in dose calculations and tracking. The app also includes a missed meal dose identification feature.

The app is said to determine the optimal dose of insulin based on glucose levels, carbohydrate intake, and insulin already active in the body, thereby helping to manage diabetes without the use of a pump.

Its precision allows for dosage decisions in half-units and enables automatic logging of doses, and reminders for insulin administration while providing insights into how diet and activity affect blood sugar levels.