StemCell Therapy

Clinical studies are underway for a new advanced digital therapy app from Amalgan Rx that can optimize fasting glucose levels in patients with type 2 diabetes.

Kristopher Sturgis

Amalgam Rx, a new digital health company launched this month, might be one of the startups in 2017 worth keeping an eye onespecially if youre one of the 30 million people managing type 2 diabetes in this country. The digital health pioneers just announced the launch of their first next-gen technology known as iSage Rx, the worlds first FDA-cleared insulin titration app for all brands of basal insulin.

One of the painstaking requirements for patients who manage type 2 diabetes is the need to inject insulin on a daily basis to help control blood sugar levels in the body. Typically, doctors will prescribe sub-optimal doses of insulin as they observe how each individual patients body reacts. With the new iSage app, doctors will now be able to choose from multiple clinically-validated basal insulin algorithms so that they can individually tailor insulin level treatments to the specific needs of each patient.

Suzanne Clough, MD, the chief medical officer and cofounder of Amalgam Rx, said the company is currently recruiting patients for an in-depth clinical study that can examine all of the insulin algorithms that will help the company polish a technology that can titrate all brands of insulin. This will provide patients with a tool that can help them consistently reach their glucose targets.

The clinical trial will demonstrate proof of concept, Clough said, and is expected to enroll 30 patients in the treatment arm. This will be compared against a matched retrospective control group. The study is slated to be completed this year, with findings anticipated to be shared in 2018.

Clough said that the iSage technology was designed to be easy and intuitive so that virtually any physician can share the technology with their patients with ease. The system comes with telephone support and training programs to help familiarize the physicians with the platform, and can even be customized to fit patient-specific treatment protocols.

A physician can simply input some basic information about the patient, such as their name and prescribed insulin to register them in the system, Clough said. They can then choose the algorithm that best fits the patients needs, or we can help them customize and save algorithms if they want to use their own treatment protocols. In a way, the system can allow them to have standing orders that can be implemented by a nurse or medical assistant. It should take less than a minute for the office staff to complete the prescription, and once patients use the product, providers can access their data online and make updates when necessary.

The iSage Rx technology will be the first in what the company hopes will be a diverse line of clinically validated digital health therapies that can empower and engage patients with chronic diseases. Ryan Sysko, CEO and cofounder of Amalgam Rx said that innovative new digital health platforms can transform chronic disease management, and that Amalgam Rx can leverage these new technologies to enable patients to self-manage their condition without so many of the costs that come with many of the advanced platforms currently available.

Were incredibly passionate about the potential for digital health to transform the way that care for chronic disease management is delivered, he said. If we can develop and scale digital health solutions that are engaging and effective, we have a tremendous opportunity to significantly improve patient outcomes and reduce healthcare costs.

That's something Amalgam Rx has set out to do with their very first product. The company brought together experienced members from research and development, testing, regulatory, and commercialization backgrounds to collaborate and work together to create new digital therapies that are accessible and easy to use.

Were developing a platform that combines the necessary clinical, behavioral, and psychological interventions and technologies to support patients across many chronic disease domains, Sysko said. Our technology architecture will allow potential partners to pick and choose from the interventions to create custom solutions.

The company has already partnered with a life sciences company to help bring the iSage Rx to market, and Sysko said that Amalgam Rx has plans to announce a new partnership in the coming months that will forge a new application focused on psoriasis and psoriatic arthritis. He said that growing the companys non-diabetes partnerships will be a key to growing their success beyond 2018, and that new digital health technologies will be crucial when it comes to enabling patients to self-manage chronic diseases.

Our hope is to leverage all of our experience in developing and commercializing digital health products in combination with the latest cutting edge technologies to engage and support patients with chronic diseases, he said. We believe this is a key missing component in healthcare. If we can more effectively support and teach a patient self-management, were bound to improve healthcare outcomes and reduce costs.

Kristopher Sturgis is a freelance contributor to MD+DI.

[Images courtesy of AMALGAM RX]

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New Startup Aims to Change Diabetes Management - Medical Device and Diagnostics Industry

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