FDA Clears MiniMed Go for Smarter Insulin Dosing

Medtronic recently announced approval by the Food and Drug Administration (FDA) for its MiniMed Go app. 

The MiniMed Go system integrates the InPen smart insulin pen (a reusable insulin pen that uses technology to send dose information, calculations and tracking to a mobile app), with Abbott’s Instinct continuous glucose monitoring (CGM) sensor through the MiniMed Go app. 

Who is the MiniMed Go system for?

The MiniMed Go system would help more than 15 million people around the world who still rely on multiple daily injections (MDI therapy). Unlike people who use insulin pumps who are used to logging their insulin boluses and basal rates, blood sugar levels, carbohydrates eaten and insulin absorbed at their fingertips, tracking all of this daily without technology can be a lot more difficult. 

Missed and miscalculated insulin boluses, even as few as two per week, can increase A1C by 0.4 percent, raising the risk of both short- and long-term complications. 

What does the MiniMed Go system do?

The MiniMed Go app hopes to change that for people on daily injections. This powerful integration will deliver real-time, personalized guidance and insights into diabetes management, including:

• An insulin dose calculator to make dosing easier
• A missed insulin dose alert to help prevent blood sugar spikes after eating 
• Action-oriented guidance when you miss or miscalculate an insulin dose
• Software reporting to share information and data with your healthcare provider

“For too long, people using injections have carried the weight of diabetes management without access to the algorithms that make automated insulin delivery (AID) systems so powerful,” said Que Dallara, evp and president of Medtronic Diabetes and CEO-designate of MiniMed. 

She continues, “MiniMed Go is designed to change that, bringing the smarts of an AID system to individuals who prefer an insulin pen. The system helps take the guesswork out of MDI therapy, delivering simplicity and confidence in every dose. 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.”

How does the MiniMed Go system work? 

If you’re already on MDI therapy, you can use your Inpen Smart Insulin pen as you normally would. But when you pair it with the Instinct CGM sensor, all the data will integrate in the newly-approved MiniMed Go mobile app. 

The app will pull glucose readings from the CGM sensor, which can help inform you of how much insulin you’ll need for a meal. It then tracks insulin-on-board from prior doses and calculates doses for carbohydrates, which could even help you make better-informed meal-time decisions.

It will also alert you if it senses that you missed a meal bolus to help decrease high blood sugars. 

When will the MiniMed Go system be available?

The MiniMed Go system is set to launch in the US in the spring. 

The system has been approved for people with insulin-requiring type 1 and type 2 diabetes who are seven years or older, as well as for children ages two to six years under the care of an adult. 

Use of Medtronic’s Simplera CGM sensor (for individuals 18 and older) with the MiniMed Go app is currently under FDA review.