Smart MDI insulin management with real-time decision support

Medtronic has received U.S. FDA 510(k) clearance for the MiniMed Go app, enabling a Smart Multiple Daily Injection (MDI) system that integrates a connected insulin pen with continuous glucose sensing to support insulin-requiring diabetes management.

Regulatory clearance and system scope
The MiniMed Go Smart MDI system has been cleared by the U.S. Food and Drug Administration for people with insulin-requiring type 1 and type 2 diabetes aged seven years and older, as well as for children aged two to six years under adult caregiver supervision. The system combines a smart insulin pen, a continuous glucose sensor manufactured by Abbott, and a mobile application that acts as the central control and analytics layer. Compatibility with an additional glucose sensor platform remains under regulatory review.

Addressing complexity in injection-based therapy
More than 15 million people globally manage diabetes using multiple daily insulin injections. This therapy model requires repeated dose calculations based on carbohydrate intake, glucose levels, and timing, increasing cognitive load at every meal. Missed or incorrect bolus doses are a known contributor to suboptimal glycemic control.

Clinical evidence indicates that missing as few as two insulin doses per week can increase HbA1c by up to 0.4 percent, elevating the risk of acute and long-term complications. These outcomes highlight the need for decision-support tools that reduce reliance on manual calculations and memory in daily diabetes care.

Data-driven guidance and alerting
The MiniMed Go system uses connected device data to generate real-time insights and actionable guidance. Key functions include missed-dose detection, automated dose calculation, and context-based recommendations when insulin dosing deviates from expected patterns. These capabilities are designed to replicate algorithmic support typically associated with automated insulin delivery systems, while remaining compatible with injection-based therapy.

Historical real-world data from earlier Smart MDI systems showed measurable benefits when users responded promptly to system alerts. Time in Range improved from 55.7 percent to 67.2 percent when more than 75 percent of missed-dose alerts were addressed within one hour. When corrective bolus alerts for high glucose were acted upon within one hour, Time in Range increased further to 71.5 percent. These outcomes demonstrate the clinical relevance of timely, algorithm-driven feedback.

Clinical collaboration and reporting
The system integrates with cloud-based reporting software to support data sharing between users and healthcare providers. Aggregated insulin dosing and glucose trend data can be reviewed to inform therapy adjustments, facilitating more structured clinical follow-up without increasing manual record-keeping.

Software-centric expansion of insulin delivery options
With the MiniMed Go Smart MDI system, Medtronic extends algorithm-based decision support to people who prefer insulin pens over pump-based therapy. By delivering guidance through software rather than hardware-intensive automation, the system provides a scalable approach to improving glycemic outcomes while preserving user choice in therapy modality.

The FDA-cleared platform represents a step toward broader access to data-driven diabetes management tools, supporting consistent dosing behavior and reducing the operational burden associated with multiple daily injections.

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