Missed insulin doses cause complications. A new Medtronic app can detect when patients forget a dose.

Forgetting to inject insulin before meals can be a problem that contributes to long-term complications from diabetes, which is why Medtronic designed a system that it says is the first to recommend corrections for missed or inaccurate insulin doses for people injecting insulin multiple times per day.

Operated from offices in Fridley, Medtronic announced on Wednesday the Food and Drug Administration cleared its smartphone app for the InPen insulin injector. The regulatory clearance paves the way for the launch of the company’s “Smart MDI” system, including a smart insulin pen that tracks doses and a body worn monitor that makes real-time glucose readings for people who make multiple daily injections.

Diabetes management is challenging, and figuring out insulin dose timing and size on a daily basis can cause burnout, said Que Dallara, who leads Medtronic’s diabetes unit.

“Our goal is to help simplify diabetes management and reduce guesswork by delivering smart insights that make it easier to determine insulin needs so individuals can achieve their diabetes management goals,” Dallara said in an email.

The clearance is the latest sign of momentum for Medtronic’s diabetes group, which on Tuesday reported double-digit revenue growth for the most recent quarter, outperforming the company’s other business segments. Medtronic announced in August that Abbott Laboratories, a competitor, will make a continuous glucose monitor tracking a patient’s blood sugar levels that will exclusively work with the company’s proprietary MiniMed insulin pumps.

The InPen app serves as the face of Medtronic’s Smart MDI System, which includes the continuous glucose monitor and smart insulin pen that communicate via Bluetooth with the app, called the “InPen: Diabetes Management App,” which helps people calculate accurate insulin doses.

Patients with diabetes may struggle to calculate an insulin dose based on their food intake or miss a dose when they are busy or have an irregular schedule, said Diana Isaacs, director of diabetes technology education and training at the Cleveland Clinic. This can cause their blood sugar level to spike, leading to sensations of thirst and frequent trips to the restroom as well as increase the risk for long-term complications, Isaacs said.

The system issues a “Missed Dose Alert” that helps to minimize the frequency of glucose highs and produces data for medical teams to review later.

Based on the continuous glucose monitor’s data, the app issues a recommended action when it detects that a person is having a blood sugar spike or hasn’t had an insulin dose for a while.

“Essentially, our Smart MDI system empowers individuals to spend less time thinking about diabetes and more time living their life,” Dallara said.

Medtronic said it will first release the system with people already using the company’s smart insulin pens and continuous glucose monitors as standalone products, followed by a full public commercial launch for people who receive a prescription. Dallara said the company will share more details about timing after it makes observations following the limited release.

CEO Geoff Martha has said Medtronic wants to lead the multiple-daily insulin injection market “with a technology ecosystem that is focused on achieving better control with less burden.”

Healthcare professionals have largely focused on advancing insulin pumps, but a minority of people with diabetes use pumps, Isaacs said.

“For those that don’t want to be on pumps or can’t afford a pump or whatever the reason, now they have a better option to use that will really help improve their diabetes care,” Isaacs said.