Insulin-Dependent Patients Will Be Enrolled in Clinical Trial Using iSage’s FDA Cleared Insulin Titration Application
WILMINGTON, Del., June 11, 2018 (GLOBE NEWSWIRE) -- The University of Kansas Medical Center (KUMC), a world-class academic medical center, and iSage Rx , a subsidiary of Amalgam Rx, Inc. , a leading digital therapeutics company, announced today a clinical trial to study the impact of iSage’s FDA-cleared insulin titration application. The study is funded by the Blue KC Outcomes Research Grant program through BioNexus KC (formerly known as Kansas City Area Life Sciences Institute ). Blue KC seeks to support applied outcomes research efforts that have the potential to significantly impact the delivery of healthcare. The iSage app may offer cost-savings in the short-term by reducing health care resource utilization and long-term by optimizing glycemic control, thereby reducing the complications of diabetes.
iSage is a patient-centered medical product that requires a prescription from a licensed healthcare provider and is currently cleared by the FDA for use with basal insulin. Providers can easily personalize basal insulin dosing plans for patients who then use a mobile application to track their glucose levels and adjust their insulin dose. iSage supports patients and their self-management by providing real-time and engaging education for patients starting on or struggling with basal insulin.
“The primary goal of the trial is to evaluate the effectiveness of the iSage system in reducing patients' A1c against the current standard of care,” said David Robbins, M.D., Director, KU Diabetes Institute and Principal Investigator of the study. “We look forward to testing iSage’s ability to remotely support patients as they manage the difficult task of properly dosing their insulin.”
“Our mission at iSage is to validate the vital role of insulin dose optimization in improving healthcare outcomes and reducing costs,” said Ryan Sysko, chief executive officer and co-founder, Amalgam Rx. “Nearly 50 percent of patients using basal insulin aren’t at target, which is unacceptable given that basal insulin works; we just need to get patients to the correct dose. We have the opportunity to save billions of dollars spent on insulin every year in the United States that are wasted because we’re not achieving the expected results. iSage has been developed to help providers and patients overcome the systemic barriers to effective basal insulin management. We hope to show that using patient-centered, automated tools can significantly improve the standard of care.”
About iSage Rx
iSage Rx, launched the iSage App, 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 earlier this year. 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. iSage Rx is a wholly-owned subsidiary of Amalgam Rx. For more information, visit http://isageapp.com.
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, Amalgam Rx strives to use technology to accelerate the impact and scale of medicine to improve the lives of millions of people living with chronic disease. Amalgam does this by partnering with leading life sciences companies to accelerate the R&D and commercialization of digital therapeutics. For more information, visit http://amalgamrx.com/.
