Diabetes management company DreaMed Diabetes stated on Monday that it has passed US Food and Drug Administration (FDA) De Novo request for DreaMed Advisor Pro in the management of people with type 1 diabetes who use insulin pumps and continuous glucose monitoring (CGM).

The company said the DreaMed Advisor Pro is a cloud-based digital solution generating insulin delivery recommendations by analyzing information from CGM, self-monitoring blood glucose (SMBG) and insulin pump data. The digital health factor will make pump and CGM technology valuable in diabetes management.

Applying event-driven adaptive learning, Advisor Pro refines its understanding for each individual and sends recommendations to the healthcare provider on how to optimize a patient's insulin pump settings for basal rate, carbohydrate ratio (CR) and correction factor (CF), added the company.

Additionally, the company has signed an agreement that enables Advisor Pro to be integrated into the diabetes data management platform of Glooko, a diabetes data management company.

For 2018, this is the second regulatory approval for Advisor Pro following the EU CE Mark in February 2018, concluded the company.