Voluntis Wins FDA Clearance and CE Mark for Diabetes Management App, Insulia

CAMBRIDGE, Mass. and PARIS, Dec. 6, 2016 /PRNewswire/ -- Voluntis, a company pioneering therapeutic companion software that empowers patients to self-manage chronic diseases, has received FDA 510(k) clearance, as well as the CE Mark, for Insulia®. This first-in-class global digital solution supports the effective management of type 2 adult diabetes patients treated with basal insulin.

Diabetes is a chronic condition characterized by high blood sugar levels that stem from inappropriate production or use of insulin. Nearly 30 million Americans and 400 million people worldwide have diabetes. Ninety percent of these individuals have type 2 diabetes and are often treated with basal insulin. Despite being provided with effective medications, more than half of them do not meet the recommended targets for glycemic control. Major contributing factors include challenges with insulin initiation and titration. Owing to the complications associated with diabetes, its total annual cost in the US amounts to $300 billion. Optimizing adherence to diabetes medications is recognized as one of the most effective ways of controlling disease expenditures. The cost saving opportunity in the US is estimated to be $4,690¹ per patient per year.

Insulia® Diabetes Management Companion is a prescription-only medical device that provides patients with insulin dose recommendations and educational coaching messages in response to blood glucose values and other diabetes-related data. Insulia® supports a wide variety of treatment plan configurations and evidence-based insulin adjustment rules used in routine clinical practice. First the clinician sets up a personalized treatment plan based on the patient's profile, insulin prescription and blood glucose targets. This enables Insulia® to provide automated insulin dosing recommendations to the patient. The dose adjustment algorithm is embedded in the application, and is accessible to the patient via a web portal or via iOS and Android smartphones and tablets. The patient 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 highly personalized telemedicine services, a practice increasingly supported by payers worldwide.

"Type 2 diabetes is a complex condition, especially for people who have transitioned to insulin therapy. Indeed, self-monitoring blood glucose and self-managing insulin doses is cumbersome and challenging for a majority of patients. As a result, harnessing new and reliable technologies to support patients in safely managing insulin dosing while keeping in touch with healthcare team could be well received by provider and patient communities," said Ananda Basu, MBBS, MD, Endocrinologist, Mayo Clinic, Rochester, MN. 

"To make a meaningful impact on patients' daily lives as well as clinical outcomes, we need to use intelligent digital solutions that go beyond data sharing between patients and clinicians. This is what CERITD and Voluntis have been working on together for more than 10 years, designing and evaluating software that provides automated recommendations and clinical decision support to take diabetes care management to the next level," said Guillaume Charpentier, MD, Endocrinologist, President of CERITD (Research Center for the Intensification of Diabetes Treatment).

"With companion software, we seek to contribute to the transition to value-based care, by improving quality of care and optimizing the cost of managing chronic diseases," said Pierre Leurent, Voluntis' Founder and CEO. "This simultaneous regulatory clearance of Insulia®, both in the USA and in Europe, is a unique achievement in digital health and the culmination of many years of hard work. We look forward to working hand in hand with providers and payers, as well as our business partners, to make this innovative solution widely available to patients across the globe."

Insulia® will be available to patients and healthcare providers in the first half of 2017.

About Voluntis

Pioneering therapeutic companion software, Voluntis innovates healthcare by embedding connectivity in therapeutics and medical intelligence in software. Dedicated to managing chronic conditions, Voluntis' companion software aim to enable treatment personalization, to support team-care coordination and to improve real-world outcomes. Harnessing its proprietary technology, Voluntis has developed digital solutions for diabetes, cancer, anticoagulation treatments and haemophilia. Voluntis is headquartered in Paris, France, and has offices in Cambridge, MA. For more information, visit www.voluntis.com.

Insulia® is powered by Voluntis proprietary technology platform Theraxium® that ensures data privacy and security, processes workflows and analytics, and enables interoperability with other IT platforms and devices.

¹Diabetes Care Value Program Guarantees More Affordable, Higher-Quality Diabetes Care. Express Scripts. Sep 1, 2016

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SOURCE Voluntis