New FDA Clearance Paves The Way to Optimization of Insulin Pump Therapy

DreaMed Diabetes, a developer of personalized diabetes management solutions, announced it 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.

The software would be for those using insulin pump therapy with continuous glucose sensors and/or blood glucose meters (BGMs).

DreaMed Advisor Pro previously received a CE Mark and was cleared by the FDA for people with Type 1 diabetes 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 U.S. clinics as part of the quality improvement collaboration of the T1D exchange registry.

According to 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, 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.

“Gathering data from insulin delivery tools and glucose profiles are just the first step in improving glucose control,” Phillip said. “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.

“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,” said Eran Atlas, chief executive officer of DreaMed in a statement.

He said the company will continue to develop their product 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.

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 a real-time personalized determination of the optimal treatment for maintaining balanced glucose levels and has been integrated into clinics at the University of Florida, AdventHealth Orlando, and as part of the Quality Improvement Collaboration of the T1D Exchange Registry.