Companion Medical Receives FDA Clearance for InPen Insulin Bolus Calculator

Companion Medical announced that it received FDA clearance for its InPen bolus calculator for fixed dosing and meal estimation.

Only 42% of people living with Type 1 diabetes count carbohydrates to determine their mealtime insulin dose, according to the company. Incorrect carb counting and insulin dosages often result in hypo- and hyperglycemia.

The bolus calculator is designed to remove the guesswork from insulin dosing for those with either Type 1 or Type 2 insulin-dependent diabetes, by taking into consideration each user’s current glucose level and “active insulin,” the calculation of the amount of insulin still lowering glucose from previous bolus doses.

The bolus calculator is a part of the larger InPen system, which includes a smart pen and Bluetooth-connected app that helps patients calculate insulin doses, issue dose reminders, track active insulin, and send reports to caregivers.

“The biggest predictor of better control amongst people living with diabetes is the number of insulin doses per day. 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,” said Mike Mensinger, CTO and co-founder at Companion Medical, in the company’s announcement. “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.”