Companion Medical won FDA 510(k) approval for its wireless-enabled InPen insulin pen and mobile application.

InPen is a new injector pen that actually contains computer chip technology built right into the base, including Bluetooth LE wireless capability.

This is a huge step beyond the existing insulin pens on today’s market.

The InPen will provide smart technology:
•       Collection of user’s data with transmission to an app that contains a dose calculator and  calculates insulin on board (IOB).
•       The App will allow users to set up reminders for specific times for each meal and snack, and if there is no dose by the end of that time period, the app will alert the user.
•       Remote monitoring for caregivers – users can set the app to auto text message their dosing info to a designated number of people. This can include insulin dose as well as BG and carb values (if entered manually) –all noted in a single text message.
•       Temperature sensor – this is built into the pen and will set off an app alarm if the pen’s temp drops below freezing or above body temperature, to ensure your insulin stays intact.

“FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care. The product combines the benefits of sophisticated insulin pumps with the simplicity and affordability of pens and syringes, providing patients, physicians, and caregivers increased confidence that diabetes is being managed optimally.  We are excited to be the 1st to introduce this entirely new class of insulin delivery,” CEO Sean Saint said in a press release.

“Diabetes is a complex and burdensome condition requiring accurate insulin doses to stabilize blood sugar levels and prevent long-term complications. Smart pens offer an improved dosing option for people living with diabetes, the majority of whom do not use insulin pumps. Pens make up roughly 60% of the insulin delivery market in the U.S., whereas in Europe it’s more like 80+%.  The InPen adds a clinician-configured bolus calculator to the ability to give multiple doses of insulin each day safely and discreetly.  The insulin data can be shared with clinicians, allowing for optimized treatment planning,” Dr. Timothy Bailey said in a prepared statement. “Why are we doing this? There’s a huge impression that the only worthwhile technology in diabetes is an insulin pump and CGM. 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? There was no way to remotely monitor insulin therapy until now,” notes Companion Medical’s CEO SeanSaint. He adds that a smart pen may “not be as cool as a pump, but it has the ability to improve the lives of many people.”

InPen 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.

On startup, a new user would enter personal settings just like 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.”

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 glooko or Tidepool or others who focus on data platforms.

We look forward to this great addition to our toolbox of gadgets.