First Insulin-Dosing App for Type 2 Diabetes Receives FDA Approval

iSage Rx is the only prescription-required mobile platform designed to guide patients in basal insulin titration and health self-management.

With Suzanne Sysko Clough, MD and Philip Levin, MD

Seizing on the trend in personalized medicine, the first, prescription-only mobile application, iSage Rx, received Food and Drug Administration 510(k) approval for self-management of basal insulin titration and timing.1 The platform is supported on both android and apple devices. 

“This electronic therapy app combines needed clinical and behavioral interventions to engage, support and improve the management of insulin in patients living with type 2 diabetes (T2D),” Suzanne Sysko Clough, MD, chief medical officer of AllayRx, a subsidiary of Amalgam Rx, told EndocrineWeb.

The responsive software was developed specifically for patients with T2D since their need for insulin management typically arises much later in life, unlike people with type 1 diabetes who receive intensive training in their medication needs and device management very early on, said Dr. Clough, yet, people with T2D still need the same level of support and understanding with regard to managing their medication needs but the infrastructure has simply not been there.

Woman learning to use the newly FDA approved iSage Rx self-management insulin titrating application,

iSage Rx App Functions as a Diabetes Coach

“This app may provide a solution to one of the biggest obstacles—clinical inertia—for patients with newly diagnosed T2D; these patients usually get through 1 or 2 insulin dose increases, then they quit prematurely out of insecurity or anxiety about proceeding correctly,” Philip Levin, MD, an assistant professor of medicine at Johns Hopkins School of Medicine, told EndocrineWeb.

Not only does the app make the process of titrating the right dosage for whichever form of insulin is prescribed by the clinician, the app was designed to give the clinician full freedom to choose a preferred algorithm or to customize the insulin delivery, as desired,” said Dr. Clough.

“Given the limits on time, clinicians and their staff rarely have the time to follow-up with every patient to coax them along,” said Dr. Levin, “this app fills a much-needed niche in busy practices by essentially standing in as a personal coach, with prompts, reminders, and health tips that guide patients in managing their health outcomes.” “It also lessens the burden on the practice staff and physicians once they develop a familiarity with the software, and its integration into their clinical toolbox,” he said.

The app promises to move patients forward in the process of titrating and adjusting their insulin—smoothly and consistently, said Dr. Levin.

“So far, iSage Rx has been well received by our patients who seem to manage fine with a 15-20 minute training, and at most 1 or 2 follow up calls,” he said.  Dr. Levin is one of several endocrinologists at Bay West Endocrinology Associates in Baltimore, Maryland participating in a pilot clinical trial; enrollment toward 30 patients is under way who will be followed for 90 days, to gather real world evidence of the functionality and efficacy.

Behavioral Support is a Key Component

“The behavioral curriculum uses principles from classic behavioral frameworks such as the Common Sense Model of Self-Regulation2 and the Social Theory of Learning3,4 as well as interventions that are designed to support the key determinants of self-management,” Dr. Clough said.

The aim of iSage Rx is to make the clinical initiation of insulin safer and easier by facilitating the titration and reporting process for patients, she said. This is achieved in 3 simple steps in which the patients receive prompts to record their blood sugar, set reminders, and offer empathetic, educational tips and training.

This platform allows physicians to tailor the insulin timing for individual patients by selecting the form of insulin, then choosing from among several clinically validated algorithms to establish a dosing plan that helps patients overcome obstacles commonly met with unassisted self-administration.

"Initiating and intensifying insulin are 2 of the more daunting challenges in managing patients with T2D,” said Dr. Levin. This is particularly true in the primary care setting where insulin initiation is often delayed for years and then patients tend to remain on a sub-optimal dose for far too long, he said.

iSage app is ideal for the primary care clinician to easily and simply devise a dosing plan for patients with type 2 diabetes.

Amalgam Rx is willing to share the software, at no cost, during an introductory period with endocrinologists interested in trialing the platform in their practices. Once established, iSageRx will be offered on a pay-for-performance basis.  information about trialing iSage Rx is available here.

The company plans to enhance the utility of the application by adding algorithms for use with basal insulin and GLP-1, and bolus insulin as well as integrating blood glucose and continuing glucose monitoring devices CGM glucose sensors, as well as interfacing with electronic medical records and dose-capture apps to deliver comprehensive personalized care, according to Amalgam Rx's CEO and founder Ryan Sysko. 


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