Large Clinical Study to Support Underway Reports Diabeloop

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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 optimal coverage by insurors. On this last point, we have made huge progress in France lately and Germany is ongoing.

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