FDA Clears MiniMed Go Smart MDI App for Adults and Children with T1D, T2D

On January 12, 2026, the US Food and Drug Administration (FDA) granted 510(k) clearance to Medtronic’s MiniMed Go Smart Multiple Daily Injection (MDI) app for use by patients with type 1 diabetes (T1D) or type 2 diabetes (T2D) aged ≥7 years, as well as for children between 2-6 years under adult supervision.1

The MiniMed Go Smart MDI system integrates the InPen smart insulin pen with the Instinct sensor developed by Abbott, all of which are connected through the MiniMed Go app. The system provides users with missed dose alerts to minimize glucose highs, action-oriented guidance in the event of a missed or miscalculated dose, and a dose calculator to simplify dose decision-making.1

The InPen is a reusable smart insulin pen using Bluetooth to send dose information to a mobile app. It also offers dose calculations and tracking. Abbott’s Instinct is a wearable sensor offering ≤15 days of wear, as well as being the world’s smallest and thinnest integrated continuous glucose monitor (CGM).1

“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,” Que Dallara, executive vice president and president of Medtronic Diabetes and chief operative officer-designate of MiniMed, said in a statement. “MiniMed Go is designed to change that – bringing the smarts of an AID system to individuals who prefer an insulin pen.”1

A significant portion of the MiniMed Smart MDI’s efficacy data was based on its adaptation of a similar system to the previous generation’s Medtronic Smart MDI. In 2025, a retrospective cohort analysis was conducted using the data from 1852 patients with T1D using the Smart MDI across 21 countries. This earlier system comprised the InPen insulin injector, Simplera Continuous Glucose Monitor (CGM), and the InPen phone app.2

The results of this analysis showed a mean time in range (TIR) of 55.7%, with patients responding with a bolus dose to 49.3% of missed dose alerts (MDA) and 46.6% of correct high glucose alerts (CHGA). However, patients who responded within 1 hour to >75% of alerts with a bolus dose saw higher TIRs of 67.2% (MDA) and 71.5% (CHGA). Prompt responses also displayed greater TIR. The investigators determined that user engagement with the device is crucial for optimal glycemic outcomes.2

“The system helps take the guesswork out of MDI therapy, delivering simplicity and confidence in every dose,” Dallara said. “We’re pleased to expand our full-stack insulin delivery solutions, making it seamless for our customers to find a therapy that works for them – no matter where they are in their journey.”1

According to the release, the MiniMed Go system is expected to launch in the US in the spring.1

References

1. Medtronic. Medtronic Diabetes announces FDA clearance for MiniMed Go Smart MDI system featuring Instinct sensor made by Abbott. January 12, 2026. January 12, 2026. https://news.medtronic.com/2026-01-12-Medtronic-Diabetes-announces-FDA-clearance-for-MiniMed-Go-TM-Smart-MDI-system-featuring-Instinct-sensor-made-by-Abbott

2. Laurenzi A, Edd SN, Adolfsson P, et al. Insights into the effective use of the Smart MDI system: Data from the first 1852 type 1 diabetes users. Diabet Med. 2025;42(12):e70161. doi:10.1111/dme.70161