SOURCE: Amalgam Rx

May 01, 2017 08:00 ET

Amalgam Rx Unveils iSage Rx, the First FDA-Cleared Application for Titration of all Brands of Basal Insulin

Advanced Digital Therapy Supports Patients with Type 2 Diabetes Optimize Fasting Glucose Levels

WILMINGTON, DE--(Marketwired - May 1, 2017) - Amalgam Rx, a new digital health company, today released iSage Rx, the first FDA 510(k)-cleared, prescription-only mobile application 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 iSage app contains behavioral, clinical and educational support designed 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.

"Initiating and intensifying insulin are two of the more daunting challenges in managing patients with type 2 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," says Philip A. Levin, MD, Endocrinologist at Baywest Endocrinology Center in Baltimore, MD. "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 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. Interested parties can request the ability to use the product by completing the form here. 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.

In addition to its application, iSage Rx, has created SDKs and APIs to enable potential partners to integrate iSage's algorithms and content into their own applications enabling them to further support their users in optimizing basal insulin through existing mobile interfaces. More information about partnering with iSage is available here.

"We're not focused on becoming the operating system for patients with type 2 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 2 diabetes. Today's launch of iSage Rx is the first step but, at this point, we're really just scratching the surface," says Ryan Sysko, CEO and founder, Amalgam Rx. "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."

About Amalgam Rx
Amalgam Rx creates custom, digital therapies that combine clinical and behavioral health and interventions to engage, support and improve patient self-management. Led by an experienced team of physicians, behaviorists, technologists and digital health pioneers, our goal is to use technology to accelerate the impact and scale of medicine to improve the lives of millions of people living with chronic disease. Amalgam partners with life sciences companies to accelerate the development and commercialization of innovative, clinically validated and regulatory-cleared solutions targeted to support specific chronic conditions. For more information, visit http://amalgamrx.com/.

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