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Insulia receives FDA clearance and CE mark to integrate Toujeo

Voluntis has announced that Insulia, its digital companion for people with Type 2 diabetes, has received FDA clearance and the CE mark to integrate Toujeo (insulin glargine U-300).

Insulia already received FDA clearance and the CE mark for insulins Lantus® and Levemir® in 2016. Voluntis is currently developing the extension of Insulia to include all basal insulins and GLP-1/basal insulin combinations to give access to the largest possible population with type 2 diabetes.

Insulia® is a prescription-only digital companion for people with type 2 diabetes and their care teams that helps people get to the right dose, every day. Insulia® combines a patient mobile app and health care practitioner (HCP) web portal.

The mobile app provides real-time basal insulin dosing recommendations and educational coaching messages based on blood glucose values. The HCP web portal allows HCPs to configure personalized treatment plans and prescribe the app then follow their entire patient population remotely.

Insulia® launched in the United States this month and will launch shortly in the European market.

"We're aiming to help people with type 2 diabetes get to the right dose every day, whatever their insulin," said Pierre Leurent, CEO of Voluntis. "We want to empower people with type 2 diabetes to better manage their condition through technology."

Insulia® provides automated basal insulin dose recommendations and coaching messages for people with type 2 diabetes while enabling the health care team to remotely monitor progress.

A healthcare practitioner prescribes Insulia® using their dedicated web portal and sets up the treatment plan rules that will adjust basal insulin dosing based on the person's specific needs. The user then receives an activation code to get started with their personalized app.

Once downloaded, the app uses blood glucose readings and any hypo symptoms to recommend doses in real-time. These are constantly updated using clinical algorithms built into the application.

Data is automatically shared with the health care team, who can remotely monitor the patient's progress toward their goal thanks to tailored notifications. This enables providers to deliver tailored telemedicine services, a practice increasingly supported by payers worldwide.