Enhancing insulin pump therapy
New FDA clearance clears the way for optimization of insulin pump therapy across all glucose measurement methods
PETAH TIKVA, Israel—DreaMed Diabetes’ DreaMed Advisor Pro just received U.S. Food and Drug Administration (FDA) clearance today. The Advisor Pro technology is an artificial intelligence (AI)-based insulin dosing decision support software for use by people with type 1 diabetes (T1D) who use insulin pump therapy with continuous glucose monitors (CGMs) and/or blood glucose meters (BGMs). The Advisor Pro technology uses artificial intelligence to optimize insulin administration in a streamlined and cost-effective manner.
“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,” said Eran Atlas, DreaMed CEO. “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.”
DreaMed Advisor Pro is a cloud-based digital solution which generates insulin delivery recommendations by analyzing information from CGM, self-monitoring blood glucose (SMBG), and insulin pump data. Advisor Pro applies event-driven adaptive learning, refines its understanding for each individual and sends recommendations to the healthcare provider on how to optimize a patient’s insulin pump settings for basal rate, carbohydrate ratio and correction factor.
DreaMed’s Advisor Pro previously received a CE Mark and was cleared by the FDA for people with T1D using an insulin pump and a CGM. The support system offers real-time personalized determination of the optimal treatment for maintaining balanced glucose levels. It has already been incorporated as a decision support system for optimizing insulin pump therapy in and has being integrated in clinics at the University of Florida and AdventHealth Orlando, as well as part of the Quality Improvement Collaboration of the T1D Exchange Registry.
“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,” said Professor Moshe Phillip, DreaMed’s chief science officer and the director of the Endocrinology and Diabetes Institute at Schneider Children’s Medical Center in Israel.
“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,” Phillip continued. “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.”
The NextDREAM consortium has recently completed a multicenter, multinational, randomized controlled study with 112 subjects to evaluate DreaMed Advisor Pro in comparison to experts from the NextDREAM consortium. Results are being analyzed and will be submitted to peer reviewed journals in the next few months.