Medtronic plc has reported the launch of the Inpen integrated with real-time Guardian Connect continuous glucose monitoring (CGM) data. Inpen is the first U.S. FDA-cleared smart insulin pen on the market for people on multiple daily injections (MDI).

With this integrated system, users will have real-time glucose readings alongside insulin dose information, giving them what they need to manage their diabetes in one view. Currently, Inpen is only available in the U.S.

The Inpen app will continue to display information from other currently compatible CGM systems on a three-hour delay.

"Our successful integration of these devices in just two months following the close of our Companion Medical acquisition is a testament to the close collaboration of our employees and strong passion to serve our customers with better solutions to manage their diabetes," noted Sean Salmon, executive vice president and president of the diabetes business at Medtronic.

Over the summer, Dublin-based Medtronic reported the planned acquisition of Companion Medical for an undisclosed sum. Wells Fargo’s Larry Biegelsen noted at the time that Medtronic’s dive into smart pens represented a nice opportunity. “We estimate there are about 3.5 [million] type 1 and 2 diabetes patients in the US who require MDI of insulin and only 650K or 19% are on a pump. Smart pens represent an opportunity for the other 80% of the market in our view.”

Biegelsen pegged the number of Companion Medical users at more than 20,000 and growing quickly.

Last month, during the company’s investor & analyst meeting, Salmon reemphasized his company’s expansion into MDI, marking a departure from a focus on automated insulin delivery.

“This population includes a large number of both type 1 and type 2 patients and is nearly 12x larger than the segment of predominantly type 1 patients that we serve today,” he explained. “Our entry into the market segment offers us significant growth potential with earlier access at the point of diagnosis and the opportunity to enable patients to transition from one form of insulin delivery to another as seamlessly as possible.”

Available by prescription

When asked Nov. 12 about patient access to this new option, the company told BioWorld that if an individual has Inpen and Guardian Connect, he or she may integrate the two by downloading the newest version of the Inpen app. Both options require a prescription.

In terms of pricing, the company explained that this varies depending upon insurance coverage. There is a patient access program that grants eligible customers access to the Inpen for no more than $35. It is open to individuals with commercial prescription insurance and who are not enrolled in any government-funded program that pays for prescription devices or treatments. It does not include costs related to insulin or other supplies.

“Integrating real-time Guardian Connect CGM data into the Inpen app was a first step in a broader vision to integrate products in ways that simplify diabetes management,” the company added. “We look forward to continuing to bring our solutions together in smart ways that make living with diabetes easier.”

That statement echoes what Salmon said during the company’s investor & analyst meeting. “In the future, our teams will work to integrate Inpen with our CGM platform and leverage our advanced artificial intelligence capabilities to design algorithms that deliver dosing insights informed by multiple factors like metabolism, activity level and insulin sensitivity,” he noted at the time.

At the same time, CEO Geoff Martha added that the company has been working to address underperforming businesses, to include diabetes. He added that it represents a high-growth market, but the company has been missing out lately. To help jumpstart the business, Martha placed Salmon in charge.

With that in mind, Salmon highlighted some actions he had taken to move the diabetes business forward, including installing a new leadership team and boosting R&D funding.

“[W]e partnered with Blackstone to further leverage our R&D spend, and with it, expand and accelerate our pipeline,” he added.