FDA OKs Companion Medical’s InPen for Pediatric Use

Companion Medical, manufacturers of InPen, the only FDA-cleared smart insulin pen system, today announced that they received FDA expanded clearance for all ages* to use the InPen System.
 
“We are excited that we can help younger children and even more parents navigate the challenges associated with Type 1 diabetes. Now anyone can safely use InPen to help make decisions around insulin dosing, no matter what their age,” explained Sean Saint, CEO and co-founder of Companion Medical. “Receiving a diagnosis that your child has Type 1 diabetes is a very scary and confusing time. Now that InPen is approved for all ages, the intelligence in the InPen app—including active insulin, a dose calculator to help them calculate the right amount of insulin and auto-tracking of insulin doses—can help caregivers feel more confident as they’re learning how to manage their children’s diabetes. It also enables healthcare providers access to additional insights so they can make improvements and adjustments to the child’s diabetes management plan.”
 
Companion Medical’s InPen is the only FDA-cleared, smart insulin pen system that combines a reusable, Bluetooth insulin pen and an intuitive mobile app that helps users take the right insulin dose, at the right time. With a custom dose calculator, dosing reminders and the ability to see active insulin, InPen takes the guesswork out of managing diabetes.
 
InPen user, 10 year old Sophia Krueger, understands this all too well. “The InPen is helpful to me because it makes calculating my insulin so easy. I am able to give myself insulin alone and it keeps track of how much I have given myself so my parents are able to see it. I am going to camp in North Carolina for two weeks this summer and having the InPen has made my parents feel comfortable enough to allow me to go.”
 
And her mother Maggie Krueger agrees, “We love the InPen. It has provided freedom and improved glucose control for Sophia. We are comfortable with her riding her bike to get ice cream with her friends. We can count on the InPen to dose the correct amount of insulin needed. All Sophia has to do is input her current blood sugar and the amount of carbs she intends to eat and the InPen will calculate the dose for the exact amount of insulin needed. We don’t need to worry Sophia will under dose or give herself too much insulin. It’s so perfect!”
 
“The parents of our newly diagnosed patients with Type 1 diabetes are often overwhelmed with the many responsibilities involved in attempting to successfully treat and manage diabetes,” explained Dr. Stelios Mantis, MD, MPH and Assistant Professor, Department of Pediatrics at Rush Medical College. “InPen alleviates some of the challenges of managing diabetes in young children including assisting with dosing calculations for meals and correction doses for unexpected hyperglycemia. Just as important, InPen is able to track all doses of insulin, and thus relieving families of the burden of trying to recall when and how much insulin was dosed over any given period of time. This gives parents and kids time for some of the important aspects of childhood; learning new concepts in their education, partaking in activities with their peers, and enjoying their childhood.”
 
As a leader in the development of easy-to-use, affordable insulin technology, Companion Medical was founded by people with diabetes, which propels their drive for continuous innovation and product development to help more people with insulin-dependent diabetes, globally. Companion Medical’s mission is to create ground-breaking solutions that drastically improve the lives of people living with diabetes.
 
*Ages 7 and older, or under the supervision of an adult caregiver.