FDA clearance for InPen app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera continuous glucose monitor (CGM)

The company's Smart MDI system combines its InPen  smart insulin pen with its newest Simplera CGM — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs. With this clearance, the system will be the first in the market to recommend corrections for missed or inaccurate insulin doses, providing real-time, personalized insights for individuals on multiple daily injection (MDI) therapy. 

For people with diabetes who need daily insulin injections, bolusing before a meal is essential as it helps regulate glucose levels and prevent blood sugar spikes after eating. Minimizing the frequency of these glucose highs reduces the risk of both short- and long-term complications and supports better overall health. However, it's estimated that individuals living with diabetes regularly miss 1 out of 3 doses. The Missed Dose alert function helps to minimize the frequency of these glucose highs. The Medtronic Smart MDI system reduces the guesswork out of diabetes management, helping to address a significant unmet need for MDI users who struggle with juggling numerous decisions related to insulin dosing on a daily basis.  

"I'm thrilled about the launch of the Medtronic Smart MDI system with the InPen app and Simplera CGM. This is a significant leap forward for those on multiple daily injections, offering intelligent dosing insights and simplifying diabetes management," said Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP. "By reducing the guesswork out of insulin dosing, this tool helps maintain stable blood sugars, optimize long-term health, and reduce complications from hyperglycemia.

Medtronic will initiate a limited market release beginning with existing standalone CGM and InPen  customers followed by a broad commercial launch.