Voluntis has announced receiving FDA 510(k) clearance, as well as the CE Mark, for Insulia® Diabetes Management Companion, a prescription-only digital medical device that helps manage type 2 diabetes adult patients who use basal insulin.
Insulia® provides patients with recommendations for their insulin doses. It also provides coaching depending on blood glucose levels and other data.
According to Voluntis, “Insulia® supports a wide variety of treatment plan configurations and evidence-based insulin adjustment rules used in routine clinical practice.”
Clinicians create a treatment plan, personalized for the patient based upon their records, allowing Insulia® to provide the automated dosing recommendations. The algorithm for dose adjustment is included in the application. Patients may access is through the web or iOS and Android devices as their data is automatically shared with the health care professional team. The team can monitor patient’s progress, allowing for the treatment to be personalized.
“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).
Insulia® will be available during the first half of 2017.