Novo Nordisk extends Amalgam Rx collab to bring newly CE marked insulin dosing app to Europe

Need to figure out how much insulin to administer throughout the day and stick to those fluctuating doses over time? There’s an app for that.

That insulin titration app—Amalgam Rx’s iSage Rx—will soon be available in Europe, now that the company has received a CE mark for the original software and all rebranded versions of the app.

This marks the third global clearance for iSage Rx: The app launched in the U.S. in 2017 with its 510(k) clearance from the FDA and was later cleared by Brazil’s regulatory body, ANVISA, as well.

Amalgam’s prescription-only app provides physicians with several clinically validated insulin dosing algorithms to choose from and allows them to be tailored to the individual needs of people with Type 2 diabetes.

RELATED: Digital health player Amalgam Rx launches with Type 2 diabetes app

Patients who don’t use an insulin pump or mealtime insulin have to self-administer varying levels of insulin throughout the day—a process called insulin titration—based on changes in their blood sugar levels due to physical activity and food intake.

Without any straightforward, easy-to-use tools and apps to help patients understand and adhere to those changing insulin dosages, according to Amalgam, more than 60% of basal insulin users are insufficiently titrated, and about one-third of this patient group is completely unaware of the need to titrate their insulin at all.

ISage Rx aims to solve those issues by connecting to Bluetooth-equipped blood glucose meters like those from Roche, Lifescan and Ascensia and collecting blood glucose and insulin dose readings in one centralized location.

The app also provides patients with behavioral support and educational information about titration to help them better understand the process and its potential effects as well as to boost the odds that they adhere to their individualized dosing regimen.

“Scaling prescription digital solutions remains one of the final frontiers of digital health,” said Chris Bergstrom, president of Amalgam. “Amalgam’s capabilities to market those products and integrate them into the provider workflow and patient’s daily lives are also necessary. It’s this end-to-end expertise that has attracted many of the world’s largest healthcare companies to our platform, which now supports millions of patients and thousands of providers across the globe.”

RELATED: Novo Nordisk to make its digital insulin pens compatible with Abbott, Glooko and more

With the CE mark under its belt, Amalgam Rx has also expanded its partnership with Novo Nordisk to bring the latter’s rebranded edition of iSage Rx to European diabetes patients using Novo’s range of insulins.

Their collaboration began in 2019 with the launch of the Novo-specific app, called Dose Check, in Brazil. Now, throughout 2021, Amalgam and Novo will bring Dose Check to several countries in Europe. The companies also plan to launch Dose Check in Asia this year, though the iSage Rx technology has yet to receive regulatory approval on the continent.

“The Dose Check program is evidence of Amalgam’s unique capabilities to support life sciences companies from R&D to commercialization. Amalgam now has software as a medical device solutions cleared on three continents. We look forward to expanding the Dose Check program and supporting Novo Nordisk on a global basis,” Ryan Sysko, Amalgam’s founder and CEO, said in a statement.