Medtronic scores FDA clearance for smart insulin pen app aimed at multiple daily injections

With a new smartphone app clearance from the FDA, Medtronic said it has all the pieces necessary to deliver a complete diabetes management system aimed at people taking multiple insulin injections per day.

The companion app for the InPen digital insulin pen is designed to connect with the company’s latest Simplera continuous glucose monitor, offering users personalized dosing suggestions based on real-time blood sugar readings.

Medtronic also said the app will be the first on the market to provide alerts for potentially missed or inaccurate doses—including for boluses taken before meals. The company estimates that people with diabetes may regularly miss as many as one out of every three insulin doses, which can lead to blood sugar spikes after eating.

The app’s limited release will start with current InPen and standalone CGM users, according to Medtronic, before a broader commercial launch.

Separately, the company spotlighted data earlier this week on meal detection technology from its MiniMed 780G insulin pump.

Presented at the Asian Conference on Innovative Therapies for Diabetes Management, Medtronic said that certain high-carbohydrate dishes common in the Asia Pacific region can make it difficult to deliver an accurate insulin dose for a particular meal.

“Historically, people living with diabetes have been advised to change their lifestyle and adopt lower carb diets, which can impact their connection to cultural traditions,” Robert Vigersky, chief medical officer of Medtronic’s diabetes division, said in a statement. “This is especially a challenge in Asian cultures where many meals are high in carbohydrates, requiring those who live with diabetes to interrupt mealtime routines to focus on their diabetes.”

The company said that analyzing a person’s blood sugar trends over time can help the insulin pump spot a potentially missed mealtime dose, or if it underestimated the number of carbohydrates in a dish.

In real-world data gathered from more than 17,000 people across the region, users saw their average time-in-range increase from 70.7% to 76.3% when adopting the device’s recommended settings.

“With the MiniMed 780G system, these disruptions can be avoided while glycemic control is maintained because the system can adapt to high carbohydrate meals. This permits people with diabetes to have the flexibility of living life as they want,” Vigersky said.