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FDA grants clearance for diabetes decision support software
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The FDA on Monday granted a De Novo request for an artificial intelligence-based diabetes treatment decision support software system designed to assist health care providers in the management of people with type 1 diabetes who use insulin pumps and continuous glucose monitors, DreaMed Diabetes announced in a press release.
The DreaMed Advisor Pro is a cloud-based, digital system that generates insulin delivery recommendations by analyzing information from CGM, self-monitored blood glucose and insulin pump data. The software applies event-driven adaptive learning to refine its understanding for each individual and sends recommendations to the health care provider on how to optimize a patient's insulin pump settings for basal rate, carbohydrate ratio and correction factor, according to the company.
“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 health care provider and their type 1 diabetes patients,” Eran Atlas, DreaMed CEO, said in the release. “Type 1 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.”
In anticipation of the FDA review, DreaMed and Glooko signed an agreement in 2016 enabling 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,” Russ Johannesson, CEO of Glooko, said in a statement. “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.”
The Leona M. and Harry B. Helmsley Charitable Trust, which awarded a $3.4 million grant in support of Advisor Pro in 2016, issued a statement calling the FDA approval a milestone for people living with type 1 diabetes.
“Managing T1D can be overwhelming both for people living with it, and for their clinicians,” David Panzirer, a board trustee, said in the statement. “The DreaMed Advisor Pro harnesses the power of AI to optimize insulin regimens and will undoubtedly lead to better outcomes for people living with T1D — a driving vision here at Helmsley.”
The FDA clearance is the second regulatory approval for Advisor Pro this year. The software received a European Union CE mark in February.
The approval follows the granting of a patent allowance for diabetes decision support software for patients that is in the development stage. In January, the United States Patent and Trademark Office issued a patent allowance for two dozen mechanisms behind a new decision-support tool to aid in insulin and non-insulin dosing, Glytec announced in a press release. The 24 mechanisms behind Therapy Advisor, a computer-guided decision-support tool still in development, are described as aiding personalized, computer-guided selection and dosing of any prescribed diabetes therapy regimen, including insulins, oral therapies, non-insulin injectables and combination therapies.