Advisor Pro T1D Therapy Software Granted FDA Approval

JUNE 18, 2018
Kevin Kunzmann
Advisor Pro, De Novo, FDA, diabetes, CGM, deviceThe US Food and Drug Administration (FDA) has approved a new artificial intelligence (AI) program designed to help physicians and patients optimize type 1 diabetes (T1D) treatment.

DreaMed Diabetes reported that a De Novo request for the Advisor Pro — an AI-based diabetes therapy decision support software — was granted by the FDA. The software is now indicated to assist physicians treating patients with T1D who use insulin pumps and continuous glucose monitoring (CGM).

De Novo indications are designated for new, novel devices which do not identify with a previous type of classification.

The program generates insulin delivery recommendations by analyzing provided information from CGM, self-monitoring blood glucose (SMBG), and insulin pump data. Health care providers receive optimized patient insulin pump settings for basal rate, carbohydrate ratio (CR), and correction factor (CF).

DreaMed previously received European Union (EU) market approval for both the Advisor Pro this February, and its artificial pancreas technology Glucositter in 2015.

With 1 million-plus patients with T1D in the United States — and about half of which use insulin pumps — the software could serve a valuable role in the progressive care of patients.

“Type 1 diabetes, managed with greater attention, leads to improved patient quality of life and reduced payer health-related costs,” DreaMed chief executive officer Eran Atlas said in a statement. “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 Advisor Pro will be integrated into the Glooko diabetes data management platform, after DreaMed reached an agreement with the leading company in diabetes data 2 years ago.

After awarding a $3.4 million granted supporting the development of Advisor Pro in 2016, David Panzirer, trustee of the Leona M. and Harry B. Helmsley Charitable Trust, said the indication marks a milestone for patients with T1D.

“Managing T1D can be overwhelming both for people living with it, and for their clinicians,” Panzirer said. “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."

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