'Smart' Insulin Pen With CGM First to Launch in Emerging Field

Miriam E. Tucker

November 17, 2020

Medtronic's launch of a new version of its smart insulin pen with integrated continuous glucose monitoring (CGM) is the first such "connected" device for use by people with diabetes who use multiple daily injections (MDI) of insulin.

Initially launched by Companion Medical in 2017, the InPen system is a reusable insulin injector pen combined with a smartphone app that provides insulin dose calculation information and tracking.

Medtronic acquired Companion in September 2020 and now the new version, the InPen with Real-Time Guardian Connect CGM Data, allows users to view glucose readings and insulin dose information in the same app.

The InPen, a so-called "connected delivery device," also provides reports that aggregate insulin, glucose, and carbohydrate information into graphical displays. As with other current CGM systems, the information can be sent wirelessly to a clinician. And as with insulin pumps, the pens are programmed with target blood glucose levels, insulin-to-carb ratios, and insulin sensitivity parameters. The device tracks "insulin on board" and delivers reminders for basal and bolus doses.

InPen only delivers short-acting insulin from cartridges, of all the three major brands. Patients who need long-acting insulin still need to inject that separately. 

Barry H. Ginsberg, MD, PhD, of Diabetes Technology Consultants, Arlington, Virginia, told Medscape Medical News, "People using pumps have had data integration for a while now. This is an excellent first step in data integration for people doing MDI and I am sure it will improve blood glucose control."

Asked about comparative costs, Medtronic spokeswoman Pamela Reese told Medscape Medical News, "While insurance costs will vary, the smart pen is less expensive than the insulin pump."

Smart Pens: How Large Is the Market?

Speaking on November 14 at the Diabetes Technology Society conference, Diabetes Care and Education Specialist Hope Warshaw, RD, owner of Hope Warshaw Associates, gave an overview of the current smart pen/connected delivery device landscape.

She noted that the patient population who might benefit from smart pens, those using MDI, defined as injecting both long-acting insulin and short-acting insulin before meals, may be larger than appreciated. There are about 1.6 million US patients with type 1 diabetes, of whom just 30%-40% currently use insulin pumps. In addition, of the 5.8 million with type 2 diabetes who take insulin, about 29%, or 1.7 million, use MDI.

For those with type 1 diabetes, she said that smart pens might be a good option for "people who don't want to wear the physical pump. They can deal with the sensor, but for psychological reasons or they have dermatologic issues, they just can't wear a pump."

But, Warshaw stressed, the type 2 diabetes population shouldn't be overlooked. "More and more people with type 2 diabetes are on MDI...In fact, there are more who use MDI than the entire population with type 1 diabetes...This is happening because people with type 2 are getting it earlier and living longer." 

Ginsberg views smart pens as a bridge between simple pen injectors to automated insulin delivery (AID) systems, those that link insulin pumps with CGMs.

Regarding patients with type 1 diabetes, he said, "I see pen users on MDI slowly moving to integrated systems and then when comfortable with the technology, moving to AID, finances allowing."

As for those with type 2 diabetes, he said that they "are less computer literate and less likely to move to integrated systems, but they will, over time."

In all, Ginsberg said, "I see integrated pens as increasing, not decreasing the AID market."

Emerging Field: "I Think They're Here to Stay"

The new Medtronic InPen system can still display information from other compatible CGM systems, but on a 3-hour delay. This is important, since the Guardian is not currently approved for determining insulin doses. In order to do that, users must still either use readings from another CGM system on a separate app or perform fingerstick blood glucose measurements.

The InPen is the first CGM-integrated pen device but is not likely to be the last. Similar technologies are being pursued by all three of the major insulin manufacturers and some other companies.

Eli Lilly's Humalog Tempo Pen, a modified version of KwikPen, is integrated with the Dexcom CGM. The pen itself has been cleared by the US Food and Drug Administration (FDA), but some of the component parts await authorization.

Novo Nordisk is expected to file with FDA in 2021 for its NovoPen Echo Plus.

For its part, in December 2019, Sanofi teamed up with Bioport to fit its SoloStar insulin pens with their technology called Mallya, which had received CE Mark in June 2019. That device, which clips onto the top and the button of most major pens, adds smart pen capacity via Bluetooth. BioCorp also has teamed up with other manufacturers including Roche and AgaMatrix.

Another major player, Bigfoot Biomedical, has filed with FDA for its connected pen that works with the Abbott FreeStyle Libre 2 CGM.

Warshaw advised, "We need to start talking more about the ways that peoples' wants, needs, and desires change and evolve over the person's life as their diabetes evolves and as all this technology evolves."

"Time will tell how many people will be on the very expensive [AID] systems...Pens are cheaper. The main cost is insulin. I think they're here to stay. The big insulin makers wouldn't be doing it otherwise." 

Ginsberg has no disclosures. Warshaw is a consultant and writer for Companion Medical/Medtronic and a faculty member of LifeScan Diabetes Institute.

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