What if an insulin pen could help you calculate needed doses, and then track all of your doses and times, plus IOB (insulin on board), and even send you alerts and reminders about missed doses and more? Well, it would be a pen unlike any other, in many ways mimicking the functions of an insulin pump.
This is exactly what's under development by San Diego-based Companion Medical, which scored a $3 million investment from Eli Lilly in May, on top of previous financing from Diamyd Medical.
Code named InPen, this new injector pen actually contains computer chip technology built right into the base, including Bluetooth LE wireless capability.
This is a huge step beyond the two existing first-generation "smart" insulin pens -- Lilly's own Memoir pen and the newer Echo pen from Novo Nordisk -- that only track a handful of previous doses and can't transmit that data anywhere. Also, neither of those can do math or suggest dosing.
The InPen, by contrast, offers truly smart technology:
- it collects users data and transmits it to an app that contains a dose calculator, and also calculates real-time insulin on board (IOB).
- like a pump, the companion app also allows you to set up reminders for specific times like breakfast, lunch, dinner, and bedtime snack, and if you haven’t dosed by the end of that time window, the app will alarm.
- there's 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.
- it 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.
"Why are we doing this?" asks Companion Medical CEO Sean Saint rhetorically. "There's a huge impression that the only worthwhile technology in diabetes is an insulin pump plus something -- a CGM or an algorithm. What frustrated me was learning that 93% of people can’t or won’t use a pump for whatever reason. If that’s true, how do we bring the benefits of pumps to other people?"
Saint is a veteran of the diabetes industry, having worked at Dexcom, Medtronic, and most recently as director of engineering at Tandem Diabetes Care. Ironically, he was diagnosed himself with type 1 diabetes five years ago, after working in the industry for seven years.
"There was no way to remotely monitor insulin therapy until now," he notes, adding that a smart pen is "maybe not as cool as a pump, but it has the ability to improve the lives of many people."
Cloud Tech Partners
While Companion Medical is producing its own featured app to make the system work, the company really doesn't want to get into the data / software business. They're hoping to eventually partner with the likes of Tidepool, Glooko and others who focus on data platforms.
"For now, to sell the pen and have value, users need a way to look at the data – you need an app. There’s no screen on the pen. So we make an app for that reason. But others will do that better... We would like to have as many partnerships as we possibly can, also with Dexcom so that people using both our pen and the CGM could see everything in one place," Saint tells us.
Smart Pen Details
To be clear, despite the smarts built into its base, the new InPen is purely mechanical, meaning users will still have to dial in their dose.
"If we didn't build it that way, users would have to recharge it, push a bunch of buttons, etc. Also, FDA is still uncomfortable with setting doses from an app or phone. So we can’t do that for regulatory reasons," Saint explains.
"If someone doesn’t have a smartphone, then the user experience is no worse than with a regular pen. For those who do have phones, they pretty much always have them at their side."
When getting started, a new user would need to enter personal settings just like they would with a pump: duration of insulin action, correction factor, and total daily dosage, so the system can check for max dosing. "But ours is a lot easier," Saint says. "We'd like to believe most users can do it on their own, or they can always sit down with their doctor like they do when starting on a pump."
He says they hope to have what you might call a "Setup Wizard," or setup screen that automatically opens up when the user first starts up the app. The look and feel of the app is still under development.
Design-wise, the InPen itself looks pretty standard. It will come in mulitiple color options: most likely pink, blue and grey to cover masculine, feminine and gender-neutral looks.
Priming the Pen
Since all insulin pens need to be primed before each dose (you squeeze out a little insulin in advance each time), one of my concerns was: how will the InPen know which doses actually went into the user, for data tracking purposes?
Saint says they have that all figured out. They're developing a proprietary pattern recognition feature that will automatically detect prime doses. He won't say exactly how it works, other than to say it's an extremely intelligent algorithm that can deal with a lot of variation.
"Even if people don’t prime, or are irregular about it, our algorithm will get this right -- it's very rarely wrong. Some people prime every time, some only when they put on a new needle, but they rarely replace them, and some people don’t prime at all. Our system works for all those things!"
So I assumed it might be based on the angle of the needle, but Saint says that wouldn't be smart, since some folks hold the needle downward to inject in a leg, while others hold it upwards for other body parts. Their special feature will somehow detect prime doses with no need for the user to go into the app and tag it as such. Wow!
In a way, the InPen is a memory aid like Timesulin, so you always know when you took your last dose and how much.
"But that's just one use case," Saint says. "We tried to take it about 10 steps further, with a dose calculator, and a history of EVERY dose you’ve ever taken. IOB can be customized too (the default setting will be around 4 hours for safety). And our app accounts for insulin stacking."
Regarding the Memoir and Echo pens on the market, Saint notes, "They track insulin dosing and that’s really good, but they haven’t given (the data) to you in a way that’s actionable. As in, 'How much insulin do I need to take now?' That’s what we aim to do. Our dose calculator is where the rubber meets the road. It takes all that tracking and converts it into actionable information."
Based on that vision, Saint founded Companion Medical in December 2013. The company now employs six full-time people and a number of consultants.
Unlike most of us, Saint says he had a "fantastic experience of diagnosis." There was no hospital, no DKA and essentially no drama.
"I was a runner. I had just run a half marathon, and then one day I was trying to run about 2 miles. I was very slow and not feeling right. I went home, and that night I was laying on couch completely fatigued. I started saying to my wife that I feel like I haven’t eaten but I have, like I'm getting no energy from food. Working in the diabetes industry, I had a meter at home. So I checked and was 400. I went straight to the doctor the next day."
Saint was working as Director of Advanced Technology at Tandem at the time, so of course he told people at work about his diagnosis.
"Who has 10 people at work who have type 1 to talk to? And those who don’t have diabetes want to talk to you too. They care and they're interested. We all did group carb counts at lunch!"
He says he's very grateful in particular to Jim Berkebile of Tandem (director of marketing & new product development) for his great listening skills and support. Within just three months, Saint dropped from his diagnosis A1C of 8.7 to 6.1.
He says he's been on Dexcom since the start. He wants to try Dexcom SHARE soon so his wife can follow his results. He's looking forward to the launch of Dexcom's upcoming G5, when users will no longer have to carry around a receiver.
He's also a pen user. "But I can't use my own pen yet; it's not FDA approved, so that would be illegal." Of course, Saint is anxious to try out the InPen's functionality himself.
The Insulin Pen Market
Pens make up roughly 60% of the insulin delivery market in the U.S., whereas in Europe it’s more like 80+%.
Companion Medical doesn’t expect “Type A insulin pumpers” to be interested in this product, but even some existing pumpers are looking an alternative to wearing a device attached to their body, Saint says. And the pen may be more appealing now that it will offer many of the features and benefits of a pump.
Saint also debunks the myth that pens are not as accurate as syringes. “Trials show that’s not true. You don’t need to worry about that last little drop you might see on the needle after a pen injection.”
Benefits and Reimbursement
The two potential clinical benefits of the new InPen are of course: reduction of A1C and of hypoglycemic events. These are critical in the fight for insurance reimbursement, of course.
“The biggest thing that gets you coverage is if you have a trial showcasing reduction in hypos. Insurance companies are short-sighted. They don’t care about A1C reduction – they care about cost today, because in most cases patients will be off their insurance in roughly three years.” In other words, it’s important to convince payors they can save money in ER visits due to hypos.
The company would like to run two studies for 3-6 months, looking at both hypo and A1C reduction using the InPen versus a traditional pen with no added dose calculator.
And in the meantime, how much might a patient expect to pay for the InPen? Saint says they haven’t yet begun to price it out, but the reality is that many patients get their meters and pens for free from their doctors. Big manufacturers provide for this knowing that they’ll be locking in customers for their test strips or insulin cartridges. True that!
“Still, smart pens will cost a premium over other pens, but nowhere near the cost of a pump,” Saint says.
Companion is in late-stage development of the InPen right now, ordering molds for manufacturing. Their immediate goal is of course 510K clearance, but they have not yet submitted to FDA. Still, they hope to bring the InPen to market within 2017 or even before.
These days, insulin pumps and pens don't require clinical trials prior to 510K approval, as long as their functionality is standard.
So Companion will be focusing only on human factors studies in the next months – and this may not even be necessary for the pen itself, but only for the app.
Three million dollars may seem like a lot to us laymen, but in the pharma world, it’s a small-ish investment.
Lilly is supporting Companion Medial through the new Lilly Innovation Center in Cambridge, MA. “But we’re not co-developing or using the facilities, rather mostly just having interactions with the center’s director Davakir (Ramakrishnan),” Saint tells us.
He says that Lilly appears to be developing its own version of an advanced, data-capable insulin pen, and it’s unclear whose will be ready for market first. In that sense, Lilly invested for safety’s sake so that they’re involved in either one. “We believe there’s no way a big company can do this as quickly as us,” Saint says.
But he adds: “That’s what’s so great about Lilly. They’re investing in all sorts of innovations. They’re very forward-thinking now.”
Kudos to both, we say. We look forward to this great addition to the diabetes toolbox.