FDA grants DreaMed's de novo request for device-friendly diabetes software

By Dave Muoio
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DreaMed Diabetes tool gets FDA approval

The FDA has granted Isreal-based DreaMed Diabetes a de novo request for its artificial intelligence-powered software for providers managing patients with Type 1 diabetes.

“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 1 diabetes patients,” DreaMed CEO Eran Atlas said in a statement. “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.”

The cloud-based DreaMed Advisor Pro is a diabetes treatment decision support product that analyzes data from continuous glucose monitors, insulin pumps, and self-monitoring to determine an insulin delivery recommendation. Through an event-based learning process, the software incorporates a number of components into its recommendations, including basal rate, carbohydrate ratio, and correction factor. Dosage recommendations are delivered directly to the monitoring clinician, who can push the adjustment to a patient’s diabetes management devices with the click of a button.  

“The fact that it was cleared by the FDA on a special de novo application [represents] the first time that you have an algorithm that can recommend insulin changes or dosing based on CGM data," Atlas told Babyforyou.net.ua. That was basically the main reason why the FDA wanted that to be a de novo application rather than a routine 510(k).” 

Advisor Pro received a CE mark in February, and according to the company is being used by “leading clinical centers” in both the EU and the US. The software is designed to integrate with third-party diabetes management systems, including Glooko’s platform as of .

“Clinicians really have to look at a lot of data to help really optimize those settings, and it’s almost impossible for a human to do it on their own really well,” Michelle de Haaff, vice president at Glooko, told Babyforyou.net.ua. “What DreamMed has been able to prove is that an algorithm can do it so well that, in certain cases, it can start to get better outcomes, and there is a global study going on that’s starting to show some of those outcomes.”

Glooko itself enjoyed an FDA clearance this year for its Mobile Insulin Dosing System (MIDS), another software offering that recommends long-acting insulin dose adjustments for Type 2 diabetes patients using blood glucose meter data. The agency has also cleared a few insulin dose calculator apps from Eli Lilly, Roche, and Sanofi intended for home or clinic that require manual inputs from the user.