Voluntis has secured both FDA clearance and the CE Mark for a type 2 diabetes management solution called Insulia.
The Insulia diabetes management companion is a prescription-only medical device, which offers patients with insulin dose recommendations and educational coaching messages in response to blood glucose values and other diabetes-related data.
It will support a range of treatment plan configurations and evidence-based insulin adjustment rules used in routine clinical practice.
Initially, the clinician will prepare a personalized treatment plan based on the patient’s profile, insulin prescription and blood glucose targets.
These measures allow Insulia to provide automated insulin dosing recommendations to the patient.
The dose adjustment algorithm, which is embedded in the application, is accessible to the patient through web portal, iOS and Android smartphones and tablets.
Health care team can easily access the patient data to monitor the patient’s progress and deliver personalized telemedicine services.
The company plans to commercialise the Insulia in the first half of next year.
According to the firm, around 30 million Americans and 400 million people across the world are suffering with diabetes, of which 90% individuals have type 2 diabetes.
Voluntis founder and CEO Pierre Leuren said: “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.
“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.”
Image: Voluntis’ new Insulia digital solution will be used to manage type 2 adult diabetes patients treated with basal insulin. Photo: courtesy of PRNewsFoto/Voluntis.