DreaMed wins FDA clearance for AI insulin recommendation technology

DreaMed Diabetes, the Petah Tikva-based developer of personalized diabetes management solutions, has received US Food and Drug Administration (FDA) clearance for its artificial intelligence-powered insulin recommendations technology.The company’s AI-based insulin dosing decision-support software, DreaMed Advisor Pro, aims to assist people with Type 1 diabetes (T1D) using insulin-pump therapy with continuous glucose sensors or blood glucose meters.Some 1.25 million Americans have T1D, including 200,000 people under the age of 20. By 2050, the number is expected to soar to some 5 million in the United States alone. Individuals with T1D are required to take insulin to keep blood glucose levels under control.Approximately one-quarter of US patients with T1D use both insulin pumps and continuous glucose sensors, and about 40% use insulin pumps and blood glucose meters to manage glucose levels.The cloud-based Advisor Pro software generates insulin delivery recommendations by analyzing information from continuous glucose sensors, self-monitoring blood glucose meters and insulin pump data.The technology, which received a European CE Mark last year, sends personalized, real-time recommendations to healthcare providers on how to optimize a patient’s insulin pump settings.“FDA and CE approval will enable diabetes patients to receive improved care and a higher level of expertise than the healthcare system can provide right now,” DreaMed CEO Eran Atlas told The Jerusalem Post.“Our technology is the only one that has FDA Clearance, CE Mark and Israeli Health Ministry approval to analyze glucose monitoring data and provide recommendations,” he said. “By offering such a tool into the healthcare system, we want to introduce the ability to frequently manage insulin therapy. If you frequently make insulin changes, far more than when only seeing a physician every six or 12 months, you manage to enter into better glucose control.”
DreaMed CEO Eran Atlas (|Photo Credit: DreaMed) Through personalized analysis, the technology enables those with T1D to receive accurate insulin recommendations from GPs when the limited number of diabetes specialists are unavailable. The implementation of smart glucose monitoring technology also requires the analysis of large amounts of data.A multi-center, randomized controlled study to evaluate DreaMed Advisor Pro in comparison to diabetes experts was completed in recent weeks by the NextDREAM consortium, including researchers from the United States, the European Union and Israel. Results from the study with 112 subjects are being analyzed and will be published in the next few months, Atlas said.“Gathering data from insulin delivery tools and glucose profiles is just the first step in improving glucose control,” said Prof. Moshe Phillip, DreaMed’s Chief Science Officer and the Director of the Endocrinology and Diabetes Institute at Schneider Children’s Medical Center in Israel.“DreaMed’s Advisor Pro analyzes the data and suggests changes in the therapy regimen. Its recommendations help healthcare professionals be much more efficient in understanding and making sense out of the vast amounts of data, thus allowing for more frequent intervention, optimized insulin therapy and improved metabolic control.”