Medtronic has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its MiniMed Go™ app, enabling the launch of the MiniMed Go Smart MDI system in the United States. The system connects the InPen™ smart insulin pen with the Instinct continuous glucose monitoring sensor made by Abbott, with all data and guidance delivered through the MiniMed Go app.
The MiniMed Go Smart MDI system is designed for people with insulin-requiring type 1 and type 2 diabetes aged seven years and older, as well as children aged two to six under adult supervision. Medtronic said compatibility with its Simplera™ sensor is still under FDA review.
MiniMed Go provides real-time glucose insights, missed dose alerts, insulin dose calculations, and action-based guidance when doses are missed or miscalculated. The system also integrates with Medtronic’s CareLink™ software, allowing clinicians to review data and collaborate more easily with patients.
Medtronic said the system addresses a large unmet need among people managing diabetes with multiple daily injections, a group that represents more than 15 million individuals globally. Managing injections requires frequent carbohydrate estimation and dose calculation, a daily process that can lead to fatigue, stress, and missed doses over time.
Clinical and real-world data from Medtronic’s earlier Smart MDI systems show that timely responses to alerts can significantly improve glucose control. According to the company, Time in Range increased from 55.7% to 67.2% when users responded to more than 75% of missed dose alerts within one hour. Time in Range reached 71.5% when users corrected high glucose alerts with a bolus dose within an hour.
“For too long, people using injections have carried the weight of diabetes management without access to the algorithms that make automated insulin delivery systems so powerful,” said Que Dallara, EVP and president of Medtronic Diabetes and CEO-designate of MiniMed. “MiniMed Go™ is designed to change that — bringing the smarts of an AID system to individuals who prefer an insulin pen. The system helps take the guesswork out of MDI therapy, delivering simplicity and confidence in every dose.”
Medtronic said it plans to begin the commercial rollout of MiniMed Go in the U.S. this spring.