Our CEO’s reflection on Diabeloop’s 2025 and Looking Ahead to 2026 for advancing Diabetes care together

As we step into 2026, I want to take a moment to reflect on what has been an exceptional year for Diabeloop, and to look ahead with confidence and ambition.

We closed 2025 with a major milestone: the FDA clearance of DBLG2. This achievement is truly significant, but it is only one highlight in a year marked by collective progress, execution, and impact across the company.

2025 was a year of momentum.

🌍 Patient Impact & Geographic Expansion

While a large portion of our historical DBLG1 with Accu-Chek Insight users remain loyal and confident after 4 years, despite the announced discontinuation of the pump, we have been working actively with our new partners to offer more choices and alternatives.

We are now supporting close to 3,500 patients with DBLG1 with the Kaleido pump across France, Germany, and the Netherlands. This growth has been made possible thanks to the strong commitment of our partners (particularly ViCentra and the home care provider network in France) and we will continue to expand this footprint throughout 2026.

• In September 2025, we successfully launched DBLG1 with the Dana-i pump in Germany, together with our partners SOOIL Development, Mediq, and Dexcom.
• With two product configurations now available in Europe, Diabeloop is the only algorithm accessible on both a traditional insulin pump and a patch pump.
• We continue our journey with Terumo on the closed-loop option for the MEDISAFE WITH pump for Japan.

📱 Product Innovation

• Following the CE Mark (MDR) secured for DBLG2, our smartphone-based algorithm, we initiated a pre-launch in the Netherlands and Germany and will expand as soon as Dexcom G7 integration is completed. We established the foundation of DBLG3, our next-generation product enabling the integration of our algorithm within an insulin pump.
• We kicked off a revolutionary new project with a partner that aims to significantly reshape the AID ecosystem. We will come back to that later in the year.
• We made significant progress toward a Full Closed Loop solution.

🔬 Science & Regulatory Excellence

• While the FDA clearance for DBLG2 was the high point of the year, we also secured MDR recertification, reinforcing the robustness of our quality and regulatory framework.
• Since Diabeloop’s inception, advancing knowledge on Diabetes has been at the core of our activities as we believe that this is the only way to develop and improve solutions for people with diabetes. In 2025, we had presentations and posters selected at all main congresses: ADA, ATTD, SFD as well as 4 peer-reviewed publications.

📊 Business Execution

Last but not least, we delivered on our 2025 sales objectives, initiated a major balance sheet restructuring, maintained strong expense discipline, and successfully implemented key organizational and structural evolutions.

We also secured new partnerships and projects, especially one in the US, with announcements coming in early 2026, and more opportunities already in the pipeline.

None of this would have been possible without the extraordinary dedication of Diabeloop’s teams and partners, who work every day to bring innovative, trusted solutions to people living with diabetes.

And to our shareholders, thank you for your continued trust and financial support throughout this journey.

2025 was a year of execution.
2026 will be a year of acceleration.

François Miceli
CEO, Diabeloop