Medtronic has received the US Food and Drug Administration (FDA) approval for a new InPen app designed for use with its Smart MDI (Multiple Daily Injection) system.
The new app, which features missed meal dose detection, supports the launch of the Smart MDI system with the Simplera continuous glucose monitor (CGM).
Simplera CGM is the company’s first disposable, all-in-one CGM, measuring half the size of its previous CGMs, and was granted US FDA approval in August this year.
Medtronic’s Smart MDI system combines the InPen smart insulin pen with Simplera CGM.
The medical device company intends to begin a limited market release with existing standalone CGM and InPen customers, with plans for a broad commercial launch.
Diabetes Pharmacist Diana Isaacs said: “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.
“By reducing the guesswork out of insulin dosing, this tool helps maintain stable blood sugars, optimise long-term health, and reduce complications from hyperglycaemia.”
According to Medtronic, Smart MDI will be the first FDA-approved system to provide corrections for missed insulin doses and real-time, personalised insights on MDI therapy.
Bolusing before a meal is important for people with diabetes who need daily insulin injections, to regulate glucose levels and prevent blood sugar spikes after eating.
Minimising the frequency of glucose spikes is believed to reduce the risk of both short- and long-term complications and support better overall health.
However, individuals with diabetes are estimated to miss one out of three doses regularly.
Medtronic said its new InPen app provides the Missed Dose alert function that helps minimise the frequency of glucose highs.
Its Smart MDI system reduces the guesswork in diabetes management, to support MDI users, who are struggling to make decisions related to insulin dosing daily.
