FDA approves DreaMed’s diabetes software for personalized insulin recommendations

Hand holding phone with Glooko app against background of a garden
The software analyzes data from glucose monitors and pumps to suggest insulin pump settings. (Glooko)

The FDA granted a de novo marketing authorization for DreaMed Diabetes’ decision support software, which assists healthcare providers with the treatment of Type 1 diabetes patients that use insulin pumps and continuous glucose monitoring.

The Advisor Pro software is an artificial intelligence-based solution that analyzes data from glucose monitors and pumps, as well as patient self-monitoring of blood glucose levels and food consumption.

It generates individual delivery recommendations and suggests insulin pump settings for basal rate, carbohydrate ratio and correction factor. The Petah Tikva, Israel-based DreaMed previously received CE Mark approval for Advisor Pro in February.


Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

In addition, a 2016 agreement with the Mountain View, California-based Glooko will integrate Advisor Pro into the company’s diabetes data management software. Glooko’s cloud-based platform allows patients and clinicians to view data from diabetes devices using a smartphone app or on the web.

RELATED: Glooko, Novo Nordisk unveil joint diabetes management app

DreaMed and Glooko conducted an international, controlled clinical study to evaluate Advisor Pro and assess its ability to adjust blood glucose levels compared to diabetes experts, and prevent hypoglycemic events during a six-month period. In three clinical pilot studies in Israel, Advisor Pro achieved glycemic control similar to expert-guided recommendations, the company said.

“This is a significant achievement and practical example of how AI and digital health can improve patient care and enable care teams,” said Russ Johannesson, CEO of Glooko. “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.”

Suggested Articles

By employing heart rate signals, physical activity and sleep quality, common Fitbit trackers may be able to predict the spread of the flu.

Nanox has raised $26 million to help fuel the development and commercialization of its "Star Trek"-inspired digital X-ray bed.

Oncology is clearly a major medical and societal issue, but one that sees too much focus from biopharmas at the expense of other killers.