Diabeloop obtains CE MDR certification for DBLG2

Diabeloop obtains CE MDR certification for DBLG2, its new generation hybrid closed-loop system for people with type 1 diabetes

Diabeloop, a Grenoble (France) based company in the field of technological medical devices, has obtained this August 4, 2025 the CE marking under the European Medical Device Regulation MDR 2017/745 for its new generation hybrid closed-loop system, DBLG2 System. 

DBLG2: the power of the DBLG1 algorithm, available on smartphones

DBLG2 builds on the advanced algorithm of its first closed-loop system DBLG1, whose performance has been demonstrated with real-life data from over 12,000 patients equipped across Europe. Used on a daily basis, the system showed an increase of 17.3 points in time spent in range (70-180 mg/dL), representing 4.1 additional hours per day for patients (1). In 2025, the use of DBLG1 resulted in positive or very positive satisfaction for 86% of users who participated in the survey (2).

DBLG2 offers a modernized and optimized user interface for today’s smartphones. The application, downloadable directly on the patient’s personal phone after a certifying training, eliminates the need for a dedicated terminal.

Franck, Director of Research and Development at Diabeloop:

“The deployment of our algorithm on smartphones was cited as the top priority for improvement by DBLG1 users in 2024, which is why we are particularly pleased to make this announcement today. By leveraging the technological capabilities and computing power of modern smartphones, we now offer a more seamless, intuitive, and personalized diabetes management experience. This integration not only simplifies daily tasks related to monitoring and treating the condition but also offers users a greater level of autonomy and control over their health.”

Gradual availability in Europe and expansion of partnerships

A limited launch in 2025

The launch will take place gradually, starting with limited access (pre-launch) over the next coming weeks, in Germany and the Netherlands, with Vicentra’s Kaleido pump and the Dexcom G6 CGM; followed by progressively expanded availability in these countries as well as in France, following reimbursement access procedures.

The Dexcom G7 CGM is in the process of being integrated and will soon be offered with the system, as well as compatibility of DBLG2 with iOS™ smartphones. DBLG2 will then also be offered with insulin pumps from Diabeloop’s other partners.

The DBLG1 System is currently available in Europe with 3 insulin pump partners: ViCentra( Kaleido pump),  SOOIL (DANA-i pump, and Roche (Accu-Chek Insight pump).
In parallel with the CE marking, Diabeloop has also recently finalized its FDA submission, with the aim of establishing itself in the North American market thereafter.

(1) Chico, A., Navas de Solís, S., Lainez, M., Rius, F., & Cuesta, M. (2023). Efficacy, safety, and satisfaction with the Accu-Chek Insight with Diabeloop closed-loop system in subjects withtype 1 diabetes: a multicenter real-world study. Diabetes Technology & Therapeutics, 25(4), 242-249.

(2) Data on file. Study conducted in 2025 among more than 2100 users of the DBLG1 System.

For a list of compatible smartphones, visit dbl-diabetes.com