Amalgam Rx’s iSage Rx is the first FDA-cleared app for titration of all brands of basal insulin

iSage Rx

A company called Amalgam Rx launched iSage Rx, saying that it is the first FDA 510(k)-cleared, prescription-only mobile app for the automated titration of all brands of basal insulin, including Lantus, Levemir, Toujeo, Tresiba and Basaglar. iSage allows physicians to choose from multiple clinically-validated basal insulin algorithms and tailor the algorithms to the specific needs of their type 2 diabetes patients. In addition to basal dosing support, the app also includes behavioral, clinical and educational support to help patients overcome the obstacles associated with the self-administration of insulin injection therapy. The company is working to expand its product offering to include algorithms for basal + GLP1 and bolus insulins to support the entirety of a type 2 patient’s insulin needs.

“We’re not focused on becoming the operating system for patients with type 2 diabetes; there are a lot of companies working on that,” Ryan Sysko, CEO and founder of Amalgam Rx, said in a statement. “Instead, we’re committed to creating the best insulin titration engine for patients with type 2 diabetes. Today’s launch of iSage Rx is the first step but, at this point, we’re really just scratching the surface.”

iSage Rx currently has a clinical trial of its technology underway which is expected to be completed by year’s end. The company is working with select health plans, pharmacy benefit managers, health systems, and providers at no cost during an introductory offer period to demonstrate the product’s real-world efficacy. Ultimately, iSage Rx will be available on a pay-for-performance basis driven by the product’s ability to help control patient’s glucose levels.

Beyond the app itself, Amalgam Rx has created SDKs and APIs to enable potential partners to integrate iSage’s algorithms and content into their own applications.

Looking into the future, the company wants to provide insulin titration as a service. “As we move forward, we’re working on leveraging data science, integrating BGM and CGM glucose sensors, and connecting with dose capture devices to create highly personalized and precise algorithms,” Sysko concluded.