The FDA has granted 510(k) clearance to Medtronic for its MiniMed “Go Smart” multiple daily injection system — the first smart MDI system to automatically integrate insulin dosing and glucose data within a single app.
The system connects the InPen smart insulin pen with Abbott’s Instinct sensor via the MiniMed Go app, according to a Jan. 12 company news release. The system includes real-time dose calculators, missed dose alerts and actionable guidance, and features CareLink software for provider collaboration.
MiniMed Go was cleared for individuals 7 and older with insulin-requiring Type 1 and Type 2 diabetes, and for children ages 2 to 6 under adult supervision.
Real-world data from a prior Medtronic Smart MDI system showed that users who responded to over 75% of missed dose alerts within one hour increased the time their blood sugar remained in a healthy range from 55.7% to 67.2%. That number rose to 71.5% when users responded to high glucose alerts with a corrective dose in the same timeframe.
Medtronic said it expects to launch MiniMed Go in the U.S. this spring.
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