Once upon a time, insulin pens were just another way to inject life-sustaining medication versus using a vial and syringe. But not anymore.

Today, “smart” insulin pens are poised to offer not only a more user-friendly insulin delivery option but also track dosing data that can be shared on digital platforms and integrated with other vital diabetes care information.

A growing body of research shows the benefits of smartpens, including a 2019 clinical study from Joslin Diabetes offering evidence that the ability of Bluetooth-enabled pens to track insulin dosing and timing helps improve diabetes management. (For a real-world point of view on why this matters, see our 12 problems that smartpens can help solve for people with diabetes.)

We’ve come a long way since the first insulin pen products were introduced in the late 1980s, from the pens becoming fully disposable to the introduction of digital caps that record data and beam it to mobile apps and online platforms, and now Bluetooth-enabled pens that build in data-tracking inside the device itself. More digital options for these pens are in the works, including connecting them to closed loop systems that can automatically adjust insulin doses, which traditionally was only considered an option when using an insulin pump.

Several fully connected insulin pens are under development but, to date, only one is actually available after getting approval from the U.S. Food and Drug Administration (FDA) as the first of its kind.

Companion Medical’s InPen (soon part of Medtronic Diabetes)

Launched in 2017 by San Diego-based startup Companion Medical, the Bluetooth-enabled InPen is the first-of-its-kind connected insulin pen that keeps track of dosing information and recommends doses, as well as displaying blood sugar and related data on the paired app.

It has a lot to offer:

  • It’s a reusable pen that works with short-acting insulin cartridges (Humalog, Novolog, and Fiasp), which are easily inserted into the pen device.
  • It can be dosed in half units (compared to most insulin pens, that only offer full-unit dosing).
  • It collects insulin-dosing data and transmits it to the Companion app that includes a dose calculator to recommend your dosages (like a pump’s built-in bolus calculator) and also calculates and displays real-time active insulin on board (IOB).
  • Like a pump, the Companion app also allows users to set up reminders for specific dosing times like breakfast, lunch, dinner, and bedtime snack, and if you haven’t dosed by the end of the set time window, the app will alarm.
  • While it doesn’t work with long-acting basal insulins, users can track those doses and set reminders via the mobile app.
  • It holds up to a year’s worth of insulin-dosing data.
  • It comes in three colors — blue, gray, and pink.
  • It includes a temperature sensor built into the pen that sets off an app alarm if the pen’s temp dips below freezing or above body temperature, ensuring that the insulin stays intact.
  • It allows remote monitoring — users can set the app to automatically text message their dosing info to up to five people. This can include not only every insulin dose but also blood glucose and carb values (if entered manually), all compiled into a single text message.
  • Users can share reports with healthcare providers.
  • The free Companion app works with both iOS and Android, though compatibility may depend on the particular smartphone version.
  • The pen is FDA-approved for use in all ages as of mid-2020.

Notably, in August 2020, Medtronic Diabetes acquired Companion and its InPen, adding this unique insulin delivery device to its leading lineup of insulin pumps. Now, Medtronic will have a delivery product to offer non-pumpers as well.

Once the acquisition is finalized by year’s end 2020, InPen will formally become part of the ever-evolving Medtronic lineup along with the Minimed insulin pumps and closed loop technology.

Pen caps for data tracking

The predecessor to smart insulin pens were ‘data tracking caps’ that could be fitted on top of the insulin pen. Some memorable names in that market were Timesulin, InsulCheck, and Common Sensing. Several of these are still around in different forms, being integrated into other systems.

This 2019 overview in the journal Diabetes Spectrum offers a comprehensive breakdown of the many different caps and related insulin pen components in the U.S. and worldwide. The authors note that: “Smart connected pens, devices, and attachments may aid in minimizing the long-term costs and complications of diabetes, and improve diabetes care overall.”

Beyond the InPen, a handful of new smart connected insulin pens are on the horizon and could be available in the next year or two.

Of course, one key is integration with continuous glucose monitors (CGMs) and other diabetes data platforms like Tidepool, Glooko, and Roche’s mySugr.

Bigfoot Unity

This is where the original Timesulin pen cap tech landed, at Northern California startup Bigfoot Biomedical, which has been around since 2015 and came out of the do-it-yourself diabetes #WeAreNotWaiting movement.

Bigfoot has been working since its inception to bring to market a full closed loop system dubbed Bigfoot Autonomy that uses the former Asante Snap insulin pump the company acquired.

But recently they made the decision to focus on a first-generation system centered around a smart insulin pen called Bigfoot Unity.

This system uses the “smart” digital pen cap developed by Timesulin — and acquired by Bigfoot in 2017 — as the base for its design. Yet, it goes beyond just tracking dosing data.

There will be two versions of the pen cap, one for basal (long-acting) and bolus (rapid-acting) insulin pens. Importantly, Bigfoot Unity will work with any type of insulin. The connected “smart” caps are designed to fit universally on all insulin pen models.

The caps will read CGM data directly from a future version of the Bluetooth-enabled Abbott FreeStyle Libre flash glucose monitoring sensor to make insulin-dosing decisions based on those glucose readings.

Users will even be able to scan the Libre sensor using the Bigfoot Unity pen cap, in addition to current scanning with the dedicated smartphone app. Users won’t need to pull out their phones to get dosing recommendations, as those will show up right on the pen cap.

Bigfoot filed this smart insulin pen version with the FDA in mid-2020 and hopes to get approval and launch in 2021.

NovoPen 6 and Echo Plus (delayed)

While Novo Nordisk has had some early versions of smart dose-tracking pens with attachments for several years, we’re still waiting on the next-gen connected pens with built-in connectivity using near field communication.

In 2018, Novo announced plans for its first connected smartpens, the NovoPen6 and Novo Echo Plus — newer iterations of its line of insulin pens with those same names, but bringing a new level of connectivity. These reusable pens have a tiny screen display — to view your last dose and other data — that would also be beamed to a digital platform and/or mobile app. Notably, it would have an 800-injection dose memory and a battery life of 5 years without any recharging.

Meanwhile, the Echo Plus is marketed as the kid-friendly version allowing for half-unit dosing and a bolus-maximum of 30 units, compared to the NovoPen 6 with a 1-unit minimum dose and a max of 60 units at one time.

These would be reusable pens, rather than disposable, so users would swap out a separately-prescribed cartridge containing meal-time insulins like Novolog or Fiasp; basal insulins (Tresiba, Levemir) are not offered in cartridges and will not be made as options for the EchoPen or Echo Plus.

Originally, Novo has planned to launch these in late 2019 or early 2020, but that was delayed. And then COVID-19 hit and we haven’t had any updates on the product pipeline for these connected insulin pens. Novo spokes-folk declined to comment for this article.

Eli Lilly’s new connected pen

Back in 2007, the Memoir pen, from big insulin manufacturer Eli Lilly, was the first to feature a multiple-dose memory feature. The company is currently working on updated smart delivery devices, including a hybrid tube-patch pump and a new connected insulin pen.

Lilly hasn’t released many details on the smartpen design other than to say it’s a modified version of its existing prefilled disposable pen that will have a Bluetooth-enabled attachment to communicate with a mobile app.

The pre-filled pen itself was approved by the FDA in late 2019, but Lilly has decided not to launch that pen until the connectivity aspects are also finalized and approved.

Maggie Pfeiffer, communications manager at Lilly Diabetes, tells DiabetesMine that in July, the company started a clinical trial evaluating the user experience and ease-of-use of its under-development connected pen. She says that research will help Lilly develop future iterations of its connected digital platform, including the smartpen and beyond.