Diabeloop Announces CE Marking and Gradual Launch of the New DBLG2 System, Integrated with Dexcom G7 CGM and ViCentra’s Kaleido Insulin Patch Pump.

GRENOBLE, France – Diabeloop today announced CE marking approval and the gradual European launch of its latest Automated Insulin Delivery (AID) system, DBLG2, integrated with Dexcom G7 Continuous Glucose Monitoring (CGM) system.

Available as a smartphone application on Android and coming soon on iOS, DBLG2 will be launched progressively across selected European countries in combination with the Kaleido patch pump (ViCentra). This regulatory milestone marks a significant step in Diabeloop’s strategic transition toward a pure software, patient-centric experience, paving the way for broader European commercialization of this cutting-edge hybrid closed-loop system. Additional configuration with alternative pumps will be available soon.

A Step Forward in Discretion and Sustainability

By hosting the DBLG2 algorithm directly on the patient’s personal smartphone, Diabeloop eliminates the need for a dedicated handset. This evolution delivers unmatched discretion and ease of use, while meaningfully reducing the environmental footprint associated with manufacturing and distributing dedicated hardware devices.

Combining Advanced Therapeutic Algorithms with the Power of Choice

This new configuration brings together best-in-class technologies, giving patients the freedom to build a system that fits their lifestyle:

• Diabeloop’s DBLG2 Application: Running on the user’s own smartphone, the self-learning algorithm continuously analyzes glucose data, calculates insulin needs in real time, and automatically adjusts delivery significantly reducing the daily mental burden of diabetes management. Notably, meal announcements are no longer mandatory, though announcing meals may support better glycemic outcomes.
• Dexcom G7 CGM: Its low-profile, all-in-one wearable warms up faster than any other CGM on the market, sending real-time glucose readings automatically to a compatible smart device or receiver, no fingerpricks or scanning required. Dexcom G7 also offers a suite of customizable alerts that can warn of high or low glucose levels and send predictive alerts to help users spend more time in range. Industry-leading remote monitoring and reporting capabilities also allow users to stay connected with their loved ones and care teams anytime, anywhere.
• Kaleido Insulin Patch Pump by ViCentra: Kaleido, is the smallest, lightest, and most precise insulin patch pump in its class.

“We are thrilled to bring this highly anticipated integration to the European market,” said François Miceli, Chief Executive Officer at Diabeloop. “By pairing our DBLG2 mobile algorithm with the advanced accuracy of Dexcom G7, and offering compatibility with ViCentra’s Kaleido and soon other pumps, we are empowering patients with unprecedented choice, discretion, and optimal glycemic control.”

Continuity of Support for Current DBLG1 Users

Diabeloop wishes to reassure existing users of its DBLG1 solution: The introduction of Dexcom G7 will have no immediate impact on their experience. The company will continue to fully support the current version of the solution and will provide clear guidance to help users transition smoothly when the time is right.

Availability and Indication

The commercial rollout of the DBLG2 system integrated with Dexcom G7 and Kaleido insulin pump will begin progressively across selected European countries in the coming months. Availability will vary by country and pump partner. DBLG2 is indicated for the management of adults with type 1 diabetes.