In this time of excitement around the acceleration of diabetes technology, it's not all about the Artificial Pancreas. Even the insulin pen injection devices that many of us use are getting smarter, with built-in Bluetooth allowing users to track doses and trends and share that data for a more complete management picture.
This isn't a new phenom, as we've seen these "smart pens" in the works for many years -- from Lilly's HumaPen Memoir pen several years ago, the Timesulin pen cap, and then the Echo pen from Novo Nordisk a couple years ago that tracks past doses or even the Bee pen cap most recently.
Those are four different approaches to what may be best viewed as "the first generation of smart pens."
And now, we're entering the next generation with two new, even more sophisticated connected pen devices coming out: the InPen from Companion Medical in San Diego, which received FDA approval in late July; and the Esysta smart pen from Emperra Digital Diabetes Care in Germany, which was actually launched in early August outside the U.S. and dubs therefore dubs itself "the world's first" insulin pen allowing for automatic data transfer via Bluetooth.
Companion Medical’s InPen
As a refresher, in May Companion Medical reported that it raised $3.2 million from investors, including Eli Lilly. Here’s a snapshot of the InPen's features we first reported on in July 2015:
- Contains computer chip technology built right into the base, including Bluetooth LE wireless capability
- Is refillable using either Lilly or Novo insulin cartridges (the only two types of insulin available in cartridges here in the U.S.)
- 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 your insulin is intact
- Collects users' data and transmits it to an app that contains a dose calculator, and also calculates real-time insulin on board (IOB)
- Smartphone app also allows users to set up reminders for meal and snack times, and if you haven’t dosed by the end of the set time window, the app will alarm
- Allows remote monitoring – users can set the app to automatically text message their dosing info to up to 5 people. This can include not only every insulin dose, but also BG and carb values (if entered manually) -- all compiled into a single text message
On July 27, the FDA cleared the InPen for ages 12 and older. Companion Medical’s co-founder and CEO Sean Saint says the San Diego company plans to launch this smart pen sometime in 2017, without giving a more specific date.
Saint tells us the pen comes in two models, designed for the Novo and Lilly insulin cartridges. While the two versions look and function the same, by design you can’t confuse the two because each cartridge is specific to that pen and can’t be used in the other.
As to pricing, Saint isn’t ready to talk details on that but says they "plan to pursue pharmacy reimbursement" so that a patient will only have to pay a “reasonable” co-pay.
We also asked Saint about the recent news of the Emperra-designed smart pen hitting the market internationally. He says he’s glad other companies are developing these insulin delivery devices. Clearly, he sees the InPen design as better for patients, as it’s smaller and simpler solution in the sense it doesn’t need a disposal adapter like Emperra’s pen. He reiterates that competition is good, while noting that while InPen may not be first to market overall, it is the first FDA-approved smart pen set to launch soon here in the U.S.
“Our plans moving forward are laser-focused on commercialization,” he told us following the FDA approval. “We do have several additional products in development, but are not ready to speak about those. It is a very exciting time with a lot of new capability available or coming soon.”
ESYSTA Pen by Emperra Digital Diabetes Care
You may have seen the press release fanfare around this one. The new smart pen is dubbed the ESYSTA, a name that plays off the words “electronic,” “system,” and “easy to use.” It is the world’s first of its kind, per the digital tech health company in Germany. We connected with Dr. Janko Schildt, Emperra’s chief medical officer and managing director, to learn more.
This pen and its various components are CE-marked in Europe, and Schildt says they has filed with the FDA and expects approval toward the end of 2016 -- so it may very well be neck and neck with the InPen.
You can see the German company’s website translated into English here, offering into on the business and all of its products including the insulin pen, mobile health app, an online platform, and a glucose meter in development.
ESYSTA's features include:
- Holds as much as 60 units of insulin
- Has design dimensions of 180 mm long, 23 mm high, 25 mm deep, and 65 grams weight
- Works with all three insulins on the market -- from Lilly, Novo and Sanofi. You simply attach one of three adapters for the insulin type, with no need to change the pen body
- Screen window shows last insulin dose amount and how long since you took that injection
- Has a countdown to when your next injection is needed
- Stores 1,000 data sets
- Uses regular batteries that can be replaced
- You can enter glucose results and carb info to calculate insulin-dosing data
- Sends insulin pen data to a cloud-based ESYSTA portal, which you can view online and set to share info with others like caregivers or your healthcare team. The data can also be sent to a mobile app comparable with both Android or iOS devices
The pen doesn’t currently communicate with other diabetes tracking apps, but the company says they are collaborating with some German-based telecom providers to develop a platform for interoperability. All of the data can currently be entered manually into the app.
Emperra is also exploring insurance reimbursement, using clinical study data on lowered A1Cs from a pilot project at the University of Dresden that included 200+ PWDs (people with diabetes) for more than a year. They've already secured full reimbursement for patients in Germany, and are now focused on contracting with additional telemedicine and coaching service providers to make this a more comprehensive approach for the U.S. market.
As to competitive advantage, Emperra says its ESYSTA is the only Bluetooth-enabled pen available in the world that fits all three insulin companies’ pens.
Dr. Schildt says the company is also developing a new glucose meter that will be able to communicate with its insulin pens, and is working with Novo Biomedical in the US and ALPS Electric in Japan/Ireland/Germany to bring that to market.
It's great see advanced technology being used to enhance all sorts of tools -- so even patients who may never wear an Artificial Pancreas can benefit from the power of data sharing.
These are exciting developments, and we look forward to eventually getting our hands on these two smart pens to test drive and share with our D-Community.