DreaMed Diabetes today said it received FDA 510(k) clearance and CE Mark approval for its DreaMed Advisor Pro software.
DreaMed Advisor Pro is an AI-based insulin dosing decision supply software designed for people with Type 1 diabetes using insulin pump therapy with continuous glucose sensors or blood glucose meters. The software previously received CE Mark approval and FDA clearance for use with a pump and CGM.
“This is the first decision support system that has been cleared to assist healthcare providers in the management of people with T1D who use insulin pumps or BGM. As such, it is an important step forward in managing T1D for every person using an insulin pump, whether they rely on CGMs or BGMs,” CEO Eran Atlas said in a news release. “We continue to develop our product so as to offer innovative, groundbreaking solutions not only to people with T1D using insulin pumps but also to people with T1D that rely on insulin injections, as well as people with Type 2. We are committed to becoming the standard-of-care for optimizing insulin therapy in all its forms, improving the quality of life of millions of people around the globe and preventing medical complications stemming from suboptimal insulin dosing.”
There are approximately 30.3 million Americans living with diabetes and 1.25 million children and adults in the U.S. have Type 1 diabetes, according to the American Diabetes Assn.
“Data from the T1D Exchange Registry demonstrate that the glucose control of people with T1D has worsened since 2012 despite an increase in the use of technology as part of the treatment,” chief scientific officer Moshe Phillip said. “Gathering data from insulin delivery tools and glucose profiles is just the first step in improving glucose control. DreaMed’s Advisor Pro analyzes the data and suggests changes in the therapy regimen. It’s 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.”