Amalgam Rx, a new company focusing on digital therapies for chronic diseases, launched Monday with the first FDA-cleared mobile app that automates the titration—or dose—of basal insulin for patients with Type 2 diabetes.
The prescription-only app, iSage Rx, is designed for patients who don’t use mealtime insulin or an insulin pump, the company said in a statement. It allows physicians to choose from a range of clinically validated basal insulin algorithms and adapt them for individual patients.
In addition to automating insulin titration, the app also includes behavioral, clinical and educational support for patients who are self-administering insulin. This includes supportive messages, video content on how to administer insulin and details on what to expect after being on insulin for certain periods of time, said founder and CEO Ryan Sysko.
Amalgam is recruiting for a proof-of-concept study in which 30 patients will use the app for 90 days, Sysko said. It will follow the change in patients’ glucose control in a bid to show how a completely automated titration app can support a patient on insulin.
Pharma companies are starting to realize the need to move beyond the pill, Sysko said. The industry is moving from a “pay-for-widget to a pay-for-outcomes model,” he said, and the only way to do this is to change the way care is delivered.
“People living with a chronic disease make a multitude of seemingly minor decisions every day that have a major impact on their condition," said founder and Chief Medical Officer Suzanne Clough in the statement.
“For healthcare providers, technology that makes patients’ self-management easier is the only way that we can scale to meet the growing need while also improving outcomes and reducing costs,” she said.
This isn’t Sysko and Clough’s first rodeo: The pair founded WellDoc, which markets the BlueStar app, a prescription-only diabetes management platform. And although Amalgam’s current focus is diabetes, the company plans to partner with life science and pharma companies on digital therapies for other chronic diseases.
And though Amalgam has launched its own titration app, the company is gearing up to create a “titration engine” that pharma partners may integrate into their own apps to support patients using their brands of insulin. To that end, the company has developed software development kits and application program interfaces.
“While we have developed an application or interface to test the efficacy of iSage, our ultimate goal is to provide insulin titration as a service,” Sysko said. “We want to enable the companies that are creating the operating systems for diabetes to easily integrate insulin titration.”