Digital health start-up Amalgam Rx launched today with the release of iSage Rx, which it touts as the 1st FDA 510(k)-cleared, prescription mobile app for insulin titration.

The app allows physicians to choose from clinically-validated basal insulin algorithms and tailor them to the needs of their patients with Type II diabetes. Patients record their blood glucose levels and if their levels are not under control, the app can suggest an increase in insulin based on their doctor’s recommendation.

Although Amalgam is focused on helping patients manage Type II diabetes, the company hopes to partner with pharmaceutical companies and develop other medication-app combinations, according to Business Insider. 

“Initiating and intensifying insulin are 2 of the more daunting challenges in managing patients with Type II diabetes. This is particularly true in primary care where insulin initiation is often delayed up to 6 years. And, when patients do start insulin, they tend to stay on a sub-optimal dose for too long,” Dr. Philip Levin, endocrinologist at Baywest Endocrinology Center, said in prepared remarks. “Tools like the iSage app are critical to supporting patient self-management and helping them overcome many of the barriers to starting and optimizing insulin management such as myth-based fears and social stigma of using insulin, low literacy and numeracy levels, and other real and perceived barriers.”

iSage Rx is conducting a clinical trial and said it expects to be finished by the end of this year.

“We’re not focused on becoming the operating system for patients with Type II diabetes; there are a lot of companies working on that. Instead, we’re committed to creating the best insulin titration engine for patients with Type II diabetes. Today’s launch of iSage Rx is the first step but, at this point, we’re really just scratching the surface,” founder & CEO Ryan Sysko said. “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. We want 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 BGM and CGM glucose sensors, and connecting with dose capture devices to create highly personalized and precise algorithms.”