Medtronic plc has received U.S. Food and Drug Administration (FDA) clearance for its updated InPen app featuring missed meal dose detection, marking a significant milestone for the launch of its Smart MDI (multiple daily injection) system. This innovative system integrates the InPen smart insulin pen with Medtronic’s Simplera continuous glucose monitor (CGM), a compact, disposable CGM that is half the size of its predecessors.
The Medtronic Smart MDI system is the first of its kind to provide real-time, personalized recommendations for missed or inaccurate insulin doses, addressing a critical need for individuals managing diabetes with MDI therapy.
“For people requiring daily insulin injections, bolusing before meals is crucial to maintaining stable glucose levels and preventing post-meal blood sugar spikes. However, research indicates that one in three insulin doses is missed. The Missed Dose alert function in the Smart MDI system is designed to address this gap, simplifying diabetes management and minimizing complications,” Medtronic noted in its announcement.
Dr. Diana Isaacs, an expert in diabetes care, praised the new system, stating, “The Medtronic Smart MDI system with the InPen app and Simplera CGM represents a significant advancement for MDI users. By offering intelligent dosing insights, it simplifies daily decision-making, helps stabilize blood sugars, and promotes long-term health.”
As reported by medicaldialogues, Medtronic plans to initiate a limited release of the system to current CGM and InPen users, with a broader commercial launch to follow. This innovative solution aims to improve diabetes management and reduce the challenges faced by those relying on multiple daily injections.