Diabeloop is expanding into the American market, offering diabetics more technology choices for managing their condition through automated insulin delivery.

The company announced that its DBLG2 device has been classified as a Class II "Interoperable Automated Glycemic Controller" (iAGC) by the FDA, officially clearing the path for its commercial availability in the United States. 

“This is a crucial milestone for the company. This clearance positions us as the reference and independent AID (Automated Insulin Delivery) partner for any pump manufacturer wishing to establish themselves simultaneously in the United States and Europe,” said François Miceli, CEO of Diabeloop. 

 

“We now offer an algorithmic platform validated in the two largest AID markets in the world, with an ongoing development in Japan.

 

“The latest data from IDF refers to 2.7 million people with T1D in Europe and between 1.4 and 1.8 million in the USA. While AID users are increasing year after year in the countries with adapted reimbursement, this is not yet adopted by the majority of patients. We are proud to enable more patients to have access to it and provide them with a choice of the technology combination they prefer.”

 

The clearance marks a major step in Diabeloop’s ambition to become a central partner for insulin pump manufacturers and expand access to automated insulin delivery in the US market. More than 12,000 patients have already benefited from DBLG1, the company’s first device launched in 2021. DBLG2, available as an Android and iOS app, builds on that foundation with enhanced features designed to simplify daily diabetes management.

 

“This is one major step in our journey, with more to come in the coming months. This agreement will accelerate our commercial roadmap considerably,” Miceli added.

 

Erik Huneker, co-founder and Director of QA, RA & CA, emphasized the patient-centered mission driving the company: "Behind this clearance are years of research and data collection with a willingness to continuously improve our outcomes and with one clear mission: helping those with Type 1 diabetes focus less on their disease and more on their lives. DBLG2 is built to adapt to real life: flexible meal announcements, sports, sleep, and rest. Making decisions easier, not harder.

 

“This step forward paves the way for us to bring DBLG2 to more people, both in the US and globally. The FDA has also Approved Diabeloop Predetermined Change Control Plan (PCCP). This mechanism allows the company to evolve its device according to a pre-established protocol for integrating new pumps or CGMs that conform to FDA requirements, without having to re-submit a 510(k) filing.”