WellDoc founders' new company, Amalgam Rx, gets FDA nod for insulin titration app

By Jonah Comstock

AmalgamRx, a newly unstealthed company founded by WellDoc founders Ryan Sysko and Dr. Suzanne Clough, has received FDA clearance for iSage, an insulin titration algorithm.

“One of the big challenges with insulin is that it’s scary for patients, they don’t necessarily want to go on it,” Sysko told MobiHealthNews. “So we wanted to find a way to help them optimize their insulin regimen and get to the right dose of insulin. Fifty-one percent of people who start on insulin don’t get the right dose and they don’t get their A1C in target, and we felt like there was a massive opportunity to leverage technology to deliver self-management support, education, and behavioral support to get patients to use the right therapy.”

iSage is a prescription-only patient-facing iOS and Android app that works in conjunction with a web portal used by the doctor. The doctor sets target levels for insulin based on the patient’s glucose levels. Then the algorithm takes over. Patients can enter their blood glucose levels and iSage will change their insulin dosing levels based on the doctor’s plan and the entered values. Currently, doctors start patients on a very low dose for safety reasons and often can’t update that does until the patient’s three month checkup, Sysko said.

“In addition to just a number, we’ve started to build this feedback and education and support for a patient that will sort of help them on their journey,” he added. “So week one might be all about setting expectations, what should they know, insulin basics. Then we might focus on insulin administration. There are trivia questions and proprietary videos that we’ve developed. All to make it a little less scary for the patient as they start the drug so we can hold their hand.”

AmalgamRx isn’t aiming to compete with the many diabetes management tech companies out there, including Sysko and Clough’s previous company WellDoc. Instead, through partnerships, APIs, and SDKs, they intend to augment services like WellDoc, Livongo, and mySugr, which Sysko refers to as “operating systems” for diabetes.

“This for us is a great area for those people who are focused on creating the operating system for diabetes to say ‘Look you can just plug us in, you don’t have to go through those regulatory hurdles to get insulin titration cleared, you don’t need to do that development work, we can accelerate your time frame by allowing you to plug in our APIs and SDKs,” he said.

Sysko and Clough have a lot of plans for the future. While the FDA-cleared algorithm works with every insulin on the market, they’re also working on new algorithms for combination therapies from Sanofi and Novo Nordisk as well as mealtime algorithms.

Integration is another area of focus for the future, whether that’s integrating with physician workflow tools or with connected glucometers, CGMs, or smart insulin pens.

“Dose capture will be an important part of titration, and we sort of expect to integrate those dose capture devices into our application in the same way that we’re working on integrating blood glucose meters and CGM via Bluetooth,” Sysko said. “At the end of the day patients are starting to expect that all of these devices can talk to one another.”SuperStar Boost SB Shoes