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FDA Grants Clearance for Digital Application for T2D Patients

The U.S. Food and Drug Administration (FDA) today granted 510(k) clearance for a global digital solution that supports the effective management of type 2 adult diabetes patients treated with basal insulin. The application will be marketed as Insulia® by the company Voluntis, which specializes in therapeutic companion software to help patients self-manage chronic diseases.

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. Insulia will 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.

“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” says Ananda Basu, MBBS, MD, an endocrinologist at the Mayo Clinic in Rochester, Minn.

“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.” says Guillaume Charpentier, MD, 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.” says 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.