Medtronic receives FDA clearance for innovative Smart MDI system with Simplera CGM integration

Medtronic plc has received U.S. Food and Drug Administration (FDA) clearance for its innovative Smart Multiple Daily Injection (MDI) system, marking a new era in diabetes management. This cutting-edge system integrates Medtronic’s InPen smart insulin pen with its newly launched Simplera continuous glucose monitor (CGM), a compact, all-in-one device. Notably, the Simplera CGM is the company’s first disposable CGM, significantly smaller than its predecessors, designed to streamline the daily routines of individuals managing diabetes.

This approval makes Medtronic the first in the market to offer a system capable of recommending corrections for missed or inaccurate insulin doses in real time. By providing personalised insights, the Smart MDI system empowers individuals on MDI therapy to make informed decisions, addressing a crucial unmet need in diabetes care.

The significance of meal-time bolusing

For people managing diabetes with daily insulin injections, pre-meal bolusing plays a pivotal role in controlling glucose levels and avoiding post-meal spikes. However, studies show that individuals with diabetes miss approximately one out of every three insulin doses, leading to frequent glucose highs that can increase the risk of severe complications over time.

Medtronic’s Smart MDI system addresses this issue with its missed dose detection feature, alerting users when they fail to administer insulin as planned. This functionality not only helps users maintain stable blood sugar levels but also supports their long-term health by reducing the risks associated with hyperglycaemia. The system eliminates much of the guesswork from daily insulin management, simplifying complex decision-making and improving the quality of life for users.

Expert endorsement highlights system’s potential

Leading diabetes care specialist Diana Isaacs expressed optimism about the impact of Medtronic’s Smart MDI system. She emphasised that tools like the InPen app and Simplera CGM simplify diabetes management by reducing the mental burden of dosing decisions. Isaacs noted that real-time, intelligent insights could help users maintain more stable blood sugar levels, optimise their health, and prevent complications.

Medtronic’s innovative system is positioned to transform the experience of MDI therapy, offering a user-friendly solution that prioritises convenience and personalised care.

Limited release marks next steps for Medtronic

Medtronic plans to initiate a phased rollout of the Smart MDI system, beginning with existing customers of its standalone CGM and InPen products. A broader commercial launch will follow, ensuring wider access to this transformative diabetes management solution.

With this FDA clearance, Medtronic reaffirms its commitment to addressing critical gaps in diabetes care through innovation, bringing new hope to millions of individuals managing their condition with daily insulin injections.