Insulia receives FDA clearance and CE mark to integrate Basaglar and Tresiba

Insulia now cleared for titration of all brands of basal insulin

CAMBRIDGE, Massachusetts, Nov. 16, 2017 /PRNewswire/ -- Today, Voluntis announced that Insulia []®, its digital companion for people with Type 2 diabetes, has received FDA clearance and the CE mark to integrate Basaglar and Tresiba. This now makes Insulia available for people using any brand of basal insulin including Lantus®, Levemir®, Toujeo®, Tresiba® and Basaglar®. Voluntis will continue to work to make Insulia available to those using other insulin therapies, including NPH insulin and GLP-1/basal insulin combinations, aiming for release in 2018.

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"It's complicated enough worrying about how to titrate your insulin, without having to worry about whether your brand of insulin is compatible with automatic titration tools such as Insulia," said Pierre Leurent, CEO of Voluntis. "We are very excited to make Insulia available to all those with type 2 diabetes, regardless of the basal insulin brand they're using."

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. Once a healthcare practitioner has issued the prescription, Insulia is available for download on the App Store [] and Google Play [].

Insulia is currently available for patients throughout the US via prescription from their provider. Voluntis is contracting with commercial health plans, pharmacy benefit managers, and governmental payers to ensure expanded coverage of Insulia as well as collaborating with health systems and providers to drive utilization of the product. Providers interested in using Insulia within their practices can enroll their clinic at [].

About Insulia®

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. Insulia is available for people using any brand of basal insulin including Lantus®, Levemir®, Toujeo®, Tresiba® (U-100) and Basaglar®. For more information, visit [].

About Voluntis

Voluntis creates digital companions that empower people to self-manage their treatment in remote collaboration with their health care teams. Dedicated to chronic conditions, Voluntis' products aim to personalize treatment, support team-care coordination and improve real-world outcomes. Voluntis leverages its expertise in digitizing clinical algorithms and its technology platform to design its companion solutions. These include Insulia and Diabeo in diabetes as well as eCO and Zemy in oncology. Voluntis has long-standing partnerships with leading life sciences companies such as Sanofi, Roche and AstraZeneca. It is a founding member of the Digital Therapeutics Alliance. For more information, visit []. [] []

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