Galway, Ireland – Medtronic has begun the European commercial rollout of its MiniMed Go™ Smart MDI system, integrating data from the InPen™ smart insulin pen and the Simplera™ sensor into a single mobile app, the company announced Wednesday.
The system is designed for individuals managing diabetes with multiple daily injections (MDI), offering real-time insights, dose alerts, and an advanced dose calculator accessible via a smartphone application. The launch will proceed incrementally across Europe throughout the month, according to Medtronic.
Unlike traditional insulin pens, the MiniMed Go™ system provides a connected experience intended to address challenges faced by those using MDI therapy. Research cited by Medtronic indicates that missing even a few insulin doses can negatively impact glycemic control, potentially increasing HbA1C levels and reducing time in range. A Medtronic study of a previous generation Smart MDI system showed users who responded to more than 75% of missed dose alerts within an hour achieved a Time in Range (TIR) of 67.2%, compared to a cohort average of 55.7%, and up to 71.5% when addressing high blood sugar alerts.
“Real-time actionable alerts are becoming the key to better clinical outcomes for people with diabetes using multiple daily injections,” said Que Dallara, EVP and president of Medtronic Diabetes and CEO-designate of MiniMed. “The MiniMed Go™ system remembers, reminds and recommends the right dose at the right time so you don´t have to.”
The system likewise includes new CareLink Clinic MDI reports, designed to help healthcare professionals interpret user data and facilitate more informed patient discussions. Dr. Martín Cuesta Hernández, an endocrinologist at Hospital Clinico San Carlos in Madrid, Spain, stated that the system has enabled evidence-based decision-making in patient care. “We’re now making evidence-based decisions instead of relying on assumptions, which has strengthened trust and improved the quality of our conversations with patients,” he said.
In Europe, the MiniMed Go™ system with the Simplera™ sensor is approved for individuals with insulin-requiring diabetes aged seven years and older, and for children aged two to six years under adult supervision. Compatibility with the Abbott-made Instinct Go™ sensor is pending CE mark approval. Once approved, users will have the option of a 7-day or 15-day sensor.
Medtronic also recently received FDA clearance for the MiniMed Go app for the InPen smart insulin pen, and FDA clearance for the MiniMed Go™ Smart MDI system featuring the Abbott Instinct sensor, though the Simplera™ sensor’s compatibility with the MiniMed Go™ system is currently under FDA review. The company also secured FDA approval for an insulin pump for use in Type 2 diabetes.
Medtronic’s Diabetes business aims to improve diabetes management through advanced technology, including continuous glucose monitoring (CGM) and intelligent dosing systems, and the application of data science and artificial intelligence. The company has been innovating in diabetes care for over 40 years.
