When Voluntis launched its diabetes management app, it worked with two types of basal insulin. Now, the company has scored FDA clearance and a CE mark to add Sanofi’s higher-concentration Toujeo to the mix.
The Insulia app earned twin U.S. and EU OKs in December 2016 to be used with Sanofi’s Lantus and Novo Nordisk’s Levemir. Designed for Type 2 diabetes patients who are treated with basal, or background, insulin, the Insulia app aims to help these patients meet their recommended blood glucose targets.
The Insulia diabetes management companion comprises a mobile app for the patient and a web portal for his or her physician. The doctor prescribes insulin and creates an individualized treatment plan using the portal. The patient then receives insulin dose recommendations and coaching messages based on real-time blood glucose data.
The new regulatory nods come just after Insulia’s U.S. launch and just ahead of its European debut. Voluntis is working to integrate all basal insulins and all GLP-1/basal insulin combos into Insulia.
In March, Paris-based Voluntis expanded its partnership with Sanofi to run pilot programs based on the Insulia platform in North America and Europe. The duo originally teamed up in 2011 to develop software that helps diabetes patients manage their basal and bolus insulin.
"Despite the availability of new medicines for the treatment of diabetes, we see that outcomes are not sufficiently improving and that more than half of patients are not well controlled," Peter Guenter, executive vice president of Sanofi’s diabetes and cardiovascular unit, said at the time. "With this in mind, Sanofi is focusing on a beyond-the-pill approach. We know that diabetes management is a 24/7 job, and we recognize that the right tools need to be developed to realize better outcomes. The long-term alliance we have with Voluntis will help us to reach that goal."