Artificial intelligence is increasingly playing a role in healthcare, especially in the diabetes management space. The latest example of this comes from Petah Tikva, Israel-based DreMed Diabetes and Mountain View, CA-based Glooko.
FDA has granted a de novo request for the DreaMed Advisor Pro, an AI-based diabetes treatment decision support software intended to help healthcare providers manage people with Type I diabetes who use insulin pumps and continuous glucose monitoring (CGM). DreaMed Advisor Pro is a cloud-based digital solution generating insulin designed to generate insulin delivery recommendations by analyzing information from CGM, self-monitoring blood glucose, and insulin pump data.
DreaMed said the technology applies event-driven learning to refine its understanding for each individual and sends recommendations to the provider on how to optimize a patient's insulin pump settings for basal rate, carbohydrate ratio, and correction factor.
“This is an innovation that can improve people’s lives and the FDA decision confirms what we believe is an important step in making a more meaningful connection between the healthcare provider and their Type I diabetes patients,” said DreaMed CEO Eran Atlas. “Type I diabetes, managed with greater attention, leads to improved patient quality of life and reduced payer health-related costs. Advisor Pro enables patients using CGM and an insulin pump to analyze data and recommend to their provider when a change in diabetes-care treatment is timely and needed.”
The company estimates that more than 1 million people in the United States have Type I diabetes, and about half of these patients use insulin pumps. This added digital health capability is a step toward making pump and CGM technology more valuable in diabetes management, DreaMed said.
Two years ago, in anticipation of the FDA review, DreaMed and Glooko signed an agreement that enables Advisor Pro to be integrated into the Glooko diabetes data management platform.
“This is a significant achievement and practical example of how AI and digital health can improve patient care and enable care teams,” said Glooko CEO Russ Johannesson. “We congratulate DreaMed and look forward to working closely with them to demonstrate that Advisor Pro can play a central role in optimizing insulin therapy.”
DreaMed is backed by The Leona M. and Harry B. Helmsley Charitable Trust, which awarded the company a $3.4 million grant in 2016 to support the Advisor Pro product.
"Managing [Type I diabetes] can be overwhelming both for people living with it, and for their clinicians," said David Panzirer, a Helmsley trustee. "The DreaMed Advisor Pro harnesses the power of AI to optimize insulin regimens, and will undoubtedly lead to better outcomes for people living with [the disease] – a driving vision here at Helmsley.”
This is the second regulatory nod for Advisor Pro this year. In February the company received the CE mark to sell the solution in the European Union. That followed the 2015 CE mark of DreaMed's In addition, artificial pancreas technology, Glucositter, which is licensed by Medtronic.
The de novo request for the DreaMed Advisor Pro is the latest example of how AI is disrupting the diabetes space. Just last month, FDA granted an investigational device exemption (IDE) for startup company Beta Bionics to begin recruiting patients for home-use studies testing an insulin-only configuration of the iLet bionic pancreas system. The company is combining AI and glucose monitoring to develop the system.
Last year a diabetes system built on an adaptive AI platform went up against some of Europe's best diabetes specialists in an observational study and won, proving that AI has value in diabetes management. For more on that study, check out this story.