The new InPen system has been designed to help calculate insulin doses, issue dose reminders, track active insulin and send reports to caregivers
Companion Medical, a medical devices firm focused on diabetes management, has received the US Food and Drug Authority (FDA) approval for its InPen bolus calculator, designed to measure the fixed dosing and meal for diabetics.
The company said that its new bolus calculator will consider current glucose level and active insulin for each user, and eliminates the guesswork from insulin dosing. Active insulin of a patient is determined through calculation of the amount of insulin still lowering glucose from previous bolus doses.
InPen system is available in the US, only through prescription
The new InPen system has been designed to help calculate insulin doses, issue dose reminders, track active insulin and send reports to caregivers, through a smart pen and Bluetooth connected app.
Companion Medical said that the InPen system marks the first approved device for Type 1 or Type 2 insulin-dependent diabetics, administering fixed amount of insulin or a dose based on the approximate size of their planned meal, unlike individual carb estimations.
The additional capabilities are said to enable InPen to serve the majority of patients using multiple daily injections, regardless of their personal insulin regimen.
The company has commercialised the new InPen system across the US, available only through prescription, and the app can be downloaded on the Apple App Store or Google Play.
Companion Medical CEO and founder Sean Saint said: “Our goal since launching in 2017 has been to make insulin therapy simpler for all people with diabetes – not just the most engaged or advanced. We do this by letting the InPen system do most of the heavy lifting and ease the burden.
“Similar to the first InPen dose calculator, which has been a game-changer for those of us who count carbs, this new FDA clearance for users on fixed-dose or meal estimation therapy finally offers a simple, yet advanced solution to those people living with insulin-dependent diabetes who are not expert carb counters.”
Recently, Senseonics Holdings entered into an agreement with Companion Medical to integrate Eversense CGM System real-time glucose data with the InPen smart system for insulin delivery.