Diabeloop launched a large clinical study to support its iController’s FDA clearance

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Diabeloop is happy to announce, at the ATTD Conference (February 19th-22nd), that the CERITD sponsored DBLUS real-life clinical trial dedicated to FDA submission has begun. Patients are equipped with the Dana-i pump (SOOIL), the 3rd pump which is interoperable with the Diabeloop iController.

The Automated Insulin Delivery (AID) solutions developed by Diabeloop embed therapeutic artificial intelligence to automate and personalize Type 1 diabetes management. Diabeloop’s algorithm is hosted on a dedicated handset, connected to a CGM (Continuous Glucose Monitor) and an insulin pump.

In December 2019, the company completed a record-breaking Series B funding round of 31 million euros intended to support its launch strategy in major international markets (particularly in Europe and the United States).

To make its interoperable iController available in the American market, Diabeloop launched a large clinical study followed by an extension (SP8/DBLUS) to submit its application for FDA (Food and Drug Administration) clearance.

The large real life study includes 184 patients as young as 14 years old

The SP8/DBLUS clinical study in adults and adolescents living with Type 1 diabetes is a double-arm, randomized and multicentric study, with a 3-month trial followed by a 6-month extension phase.

The main objective is to evaluate the safety of the personalized closed-loop system
developed by Diabeloop.

This new clinical trial, a partnership with 9 university hospitals, involves 184 patients (36 adolescents and 148 adults), between 14 and 75 years old and diagnosed with Type 1 diabetes. The clinical study will allow Diabeloop to submit its autonomous diabetes management solution for FDA clearance.

Diabeloop i-Controller

After successful clinical trials integrating the Cellnovo and the Kaleido (Vicentra) pumps, which have contributed to CE-marking of Diabeloop’s first product, DBLG1, Diabeloop is demonstrating again its interoperability with other insulin delivery systems. The SP8/DBLUS study combines Diabeloop’s iController with the Dexcom G6 CGM and the Dana-i pump (SOOIL).

Diabeloop partners with SOOIL and integrates the Dana-i pump

Diabeloop leveraged its SP8/DBLUS study to introduce its partnership with SOOIL, whose Dana-i Diabecare Pump is integrated in the closed-loop system trial.

The small, light Dana-i pump is currently in the process of being CE-marked. The study will
also support SOOIL’s Dana-i submission for FDA ACE pump clearance.

Professor Soo Bong Choi, founder of SOOIL development Co and Diabecare DANA insulin pumps said “I congratulate Diabeloop, for hard work and dedication within algorithm environment. I am pleased to offer the global diabetes community this alternative DANA-i pump option in collaboration with Diabeloop. Interoperable connections such as this will assist with improving the quality of life and reducing the burden and complications for all people with diabetes worldwide.”

Erik Huneker, Diabeloop founder and co-CEO concludes: “Our objective has always been to make innovation accessible to most T1Ds. It means for us two main goals: on one hand, to pursue our efforts of interoperability of our solutions and on the other hand to ensure an optimal coverage by insurors. On this last point, we have made huge progress in France lately and Germany is on going.”

 

About Diabeloop

Diabeloop’s mission: to relieve people living with Type 1 diabetes from dozens of therapeutic decisions and reduce their heavy mental burden. Initially conceived from a medical research project, Diabeloop was created in 2015 by Dr. Guillaume Charpentier, now Chief Medical Officer, and Erik Huneker who have co-managed the company with Marc Julien since 2016. This complementary management team works with experienced partners, CEA-Leti (a research laboratory) and CERITD (a French research team of diabetologists). In November 2018, the DBLG1 System, Diabeloop’s first medical device for automated diabetes management, obtained CE marking.

A second round of financing of 31 million euros concluded in November 2019 to speed up the international commercial rollout of the DBLG1 iController and support an ambitious R&D program.

Today, Diabeloop gathers the personality, the passion and the skills of 70 talented individuals
who work hard to improve the quality of life for every person living with Type 1 diabetes.

About SOOIL Development Co Limited.

Founded in 1979 in Seoul, South Korea. DANA was the first commercial insulin pump (released in 1980). SOOIL has continued to innovate and develop small, light, discrete, dependable and reliable insulin pumps for 40 years – much longer than any other pump company. DANA innovated Bluetooth connectivity and has been a market leader in safe secure interoperable insulin pumps.

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Press contact :
Stéphanie JEGU – stephanie.jegu@diabeloop.com