Amalgam Rx launches iSage Rx, the first FDA cleared mobile app for automated titration of all basal insulin brands

Digital health start-up Amalgam Rx on Monday unveiled iSage Rx, which the company said is the "first FDA 510(k)-cleared, prescription-only mobile application for the automated titration of all brands of basal insulin," including Sanofi's insulin glargine injections Lantus and Toujeo, Novo Nordisk's Levemir (insulin detemir) and Tresiba (insulin degludec), as well as Eli Lilly and Boehringer Ingelheim's Basaglar (insulin glargine).

According to Amalgam Rx, the app allows doctors to choose from "multiple clinically-validated basal insulin algorithms" that can be tailored to the specific needs of their patients with type 2 diabetes. Additionally, iSage Rx contains "behavioural, clinical and educational support designed to help patients overcome the obstacles associated with the self-administration of insulin injection therapy," the company added.

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CEO Ryan Sysko remarked "we're not focused on becoming the operating system for patients with type 2 diabetes [as] there are a lot of companies working on that. Instead, we're committed to creating the best insulin titration engine." He added that Amalgam Rx wants "to enable the companies that are creating the operating systems for diabetes to easily integrate insulin titration. As we move forward, we're working on leveraging data science, integrating [blood glucose monitoring] and [continuous glucose monitoring] sensors, and connecting with dose capture devices to create highly personalised and precise algorithms."

The technology is currently being tested in a clinical trial, which is expected to be completed by the end of the year. Amalgam Rx said it is working to expand its product offering to include algorithms for basal plus GLP-1 and bolus insulins "to support the entirety of a type 2 patient's insulin needs."

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