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Classified in: Health, Science and technology
Subjects: PDT, FDA

New FDA Clearance Paves The Way to Optimization of Insulin Pump Therapy Across All Glucose Measurement Methods

PETAH TIKVA, Israel, Sept. 16, 2019 /PRNewswire/ -- DreaMed Diabetes, developer of personalized diabetes management solutions, announced today that it has received U.S Food and Drug Administration (FDA) clearance as well as CE Mark for DreaMed Advisor Pro, an artificial intelligence (AI)-based insulin dosing decision support software, for use by people with Type 1 diabetes (T1D) using insulin pump therapy with continuous glucose sensors and/or blood glucose meters (BGMs). This clinical and technological advance leverages the power of artificial intelligence to optimize insulin administration in a streamlined and cost-effective manner.

DreaMed Advisor Pro previously received a CE Mark and was cleared by the FDA for people with T1D using an insulin pump and a continuous glucose monitor (CGM) and has already been incorporated as a decision support system for optimizing insulin pump therapy in several US clinics as part of the quality improvement collaboration of the T1D exchange registry.

"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 DreaMed CEO Eran Atlas. "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."

"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 [1]," 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. "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. 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."

About DreaMed Advisor Pro

DreaMed Advisor Pro is a cloud-based digital solution generating insulin delivery recommendations by analyzing information from CGM, self-monitoring blood glucose (SMBG), and insulin pump data. Applying event-driven adaptive learning, Advisor Pro 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 (CR) and correction factor (CF). In 2018, DreaMed Advisor Pro received both an EU CE Mark, as well as clearance by the FDA as a decision-support tool for people with diabetes using an insulin pump and a CGM. The support system offers real-time personalized determination of the optimal treatment for maintaining balanced glucose levels and has being integrated in clinics at the University of Florida, AdventHealth Orlando, and as part of the Quality Improvement Collaboration of the T1D Exchange Registry. 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.

Video - Product demo

About Type 1 Diabetes

There are more than one million people in the United States with Type 1 diabetes (T1D). According to the T1D Exchange [1], the largest clinic registry of patients with type 1 diabetes T1D in the U.S., only 25% of patients in the registry use both insulin pumps and CGM, but ~40% of patients in the registry use insulin pump and BGMs.

About DreaMed Diabetes 
DreaMed Diabetes develops solutions and personalized decision support solutions for the optimization of insulin therapy for people with Type 1 and Type 2 diabetes. The Company's first product, GlucoSitter was developed for closed-loop insulin therapy and was licensed to Medtronic Diabetes. The Company then developed Advisor, a portfolio of decision support solutions for patients and healthcare providers dedicated to transform dynamic, real-world patient data into actionable treatment insights with its unique, cloud-based cognitive technology. Investors in the company include Medtronic Diabetes, Norma Investments, and OurCrowd. For more information, please visit http://www.dreamed-diabetes.com.

[1] Foster NC et al, Diabetes Technol Ther; 2019, 21(2):66-72.

Company contact:
Tsipi Haitovsky
Global Media Liaison
DreaMed Diabetes


SOURCE DreaMed Diabetes

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