Ask anyone who manages their diabetes with insulin injections about the challenges this presents, and they will likely mention tracking doses and ensuring accurate dosing. The wrong dose of insulin can be life threatening or even deadly.
The FDA has granted approval on a new device that promises to help solve those issues, providing many of the dosage tracking benefits of an insulin pump.
The InPen, manufactured by Companion Medical, is the first and only FDA-approved wireless-enabled insulin pen that calculates and recommends optimal dosing, tracks and records all of one's doses and times, and shares dosing information with one's health care provider through a mobile app.
"This will be a huge improvement for safety," says Aaron J. Kowalski, Ph.D., JDRF Chief Mission Officer, who also has type 1 diabetes. He has no consulting relationship with the maker of the InPen.
"It's very common to wake up, do an insulin injection and then wonder, 'Did I do that injection or didn't I do that injection?'" Kowalski says. "The current pens, they don't give you any information. The risk of missing a dose because you think you gave it and you didn't or even worse, double dosing insulin, is still fairly significant. These devices will make people safer for sure."
The InPen has been approved for use with the rapid-acting insulins Humalog and Novolog. Companion Medical CEO Sean Saint says he expects the InPen on the market in 2017. When asked about InPen's cost, he says he doesn't yet know, since insurance reimbursement issues are being worked out and the InPen is a new category device.
While Kowalski also couldn't speculate on what the InPen may cost or its true size—he hasn't seen or held the device in person—he says its possible downside may be that it is costlier and bulkier than existing pens.
The 41-year-old Saint was motivated to create the InPen following his own type 1 diabetes diagnosis six years ago.
At the time, he was a diabetes industry veteran working for an insulin pump manufacturer. "I was trying to figure out how to get more people to use our insulin pump," Saint says. "But I realized that 93 percent of people who take insulin are unwilling or unable to use an insulin pump for whatever reason.
"And I wanted to find a way to bring the benefits of insulin pumps to syringe users, which I think became more of a desire of mine when I became type 1," he says in explaining why he created the InPen.
The InPen is currently approved for Apple iOS and an Android version is planned for late 2016.
Emperra GmbH, a German company, announced in August the development of its Bluetooth-connected insulin pen, which records every insulin injection and shares that data with an accompanying iOS or Android app. "This technology is simple but I think it's very important," Kowalski says. "I'm really thrilled to see it come along."