FDA clears InPen diabetes management system

Chloe Kent 28 February 2020 (Last Updated February 28th, 2020 11:46)

Companion Medical has received clearance from the US Food and Drug Administration (FDA) for its InPen bolus calculator, which manages fixed insulin dosing and meal estimation for diabetics.

FDA clears InPen diabetes management system
The InPen system uses a smart pen and Bluetooth-enabled app to calculate insulin doses, issue dose reminders, track active insulin and send reports to caregivers. Credit: Companion Medical

Companion Medical has received clearance from the US Food and Drug Administration (FDA) for its InPen bolus calculator, which manages fixed insulin dosing and meal estimation for diabetics.

The calculator takes into consideration each user’s current glucose level and active insulin, calculating the amount of insulin still lowering from previous doses to remove the guesswork involved in diabetes management.

The device is cleared for both Type I and Type II diabetics who administer insulin for meals or deliver doses based on the approximate size of their planned meal, as opposed to those who use individual carbohydrate estimations.

Only 42% of people living with Type 1 diabetes count carbohydrates to determine their mealtime insulin dose according to Seagrove Partners’ 2019 Patients Perspectives Report. It is generally considered to be a frustrating and time-consuming process which can be difficult to adapt to for newly diagnosed people.

Companion Medical founder and CEO 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.”

The Companion Medical InPen system uses a smart pen and Bluetooth-enabled app to calculate insulin doses, issue dose reminders, track active insulin and send reports to caregivers.

Companion Medical co-founder and chief technology officer Mike Mensinger said: “Patients without a dose calculator with active insulin tracking have been taught for years to dose at least four hours apart because of the dangers of insulin stacking – this allows for only a maximum of three or four doses per day.

“With the new calculator modes, InPen provides an experience consistent with these patients’ current therapies, while adjusting recommendations automatically based on their current glucose level and factoring in active insulin to safely allow correction of high blood glucose between meals.”