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.
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.
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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.”