DBLG2 from Diabeloop Becomes the First Automated Insulin Delivery (AID) Cleared by FDA and CE Mark Where Meal Announcements Are No Longer Mandatory

Grenoble, France - January 21, 2026 - Diabeloop, a pioneer in therapeutic artificial intelligence, announces that its DBLG2 AID has become the first solution cleared by both the U.S. Food and Drug Administration (FDA) and the CE Mark where meal announcements are no longer mandatory. 

Reducing Meal-Time Burden for People with Type 1 Diabetes

Non-mandatory meal announcements have been evaluated in Randomized Clinical Trials, and introduced commercially by Diabeloop in Europe early 2025 in certain versions of its software. In real life, patients chose not to announce any meal during the day around 9% of the time (from a pool of 800,000 patient-days). In the different studies, the average loss of Time-in-Range varied between 3 and 6 percentage points when no meals were announced during the day compared with full meal announcement. Overall hypoglycemia and metabolic events levels were not affected. Significant individual variability was observed, meaning this might not work as described for everyone.

Mealtimes represent one of the most significant challenges for people living with type 1 diabetes. The constant need to calculate carbohydrate intake, estimate insulin doses, and make timely dosing decisions contributes heavily to the mental burden experienced by many individuals.

With DBLG2’s advanced adaptive algorithm, users benefit from an automatic correction mechanism, even when a meal is not announced. This innovation offers a new user experience that prioritizes daily quality of life by reducing the cognitive workload associated with diabetes management, although with a potential reduction in glycemic control compared to fully announced meals.

“Reducing the need for meal-time interventions has been a longstanding goal for automated insulin delivery systems,” said Erik Huneker, co-founder and Chief Science Officer. “DBLG2’s ability to adapt in real-time and correct glycemic excursions even without manual meal input offers patients flexibility in managing their diabetes.”

Clinical Evidence Supporting Non-Mandatory Meal Declaration

Multiple studies, both Randomized Control Trials and real-life observational studies, have supported the safety and performance of DBLG2 use with optional meal announcements:

• Study SP13 (NCT04725591) – This Randomised controlled clinical trial, conducted on 49 adolescents with Type 1 Diabetes, demonstrated the safety and performance of the Diabeloop Software when no meals are announced. Specifically, the study showed that the Time-in-Range (TIR) remained statistically non-inferior to the standard use where all meals are announced (-5.89 percentage points), and almost 14 percentage points higher compared to usual treatment.
  
  
• Study Obs32 (Real-world evidence) – In this large real-world analysis, based on 1,212 adults treated with DBLG1 corresponding to 118,598 patient-days, the observed median Time-in-Range (TIR) is almost 70% during days with no meal announced. This was 3 percentage points lower compared to the median for all patient-days, while the time spent in hypoglycemia (below 54 mg/dL) remained very low and well below international recommendations.
  
  
• Study Obs36 (Real-world evidence) – In this large real-world analysis, based on 2,335 adults treated with DBLG1, a subgroup analysis based on patients’ meal declaration habits showed that the patients declaring less than one meal per day on average reached a mean Time-in-Range of 67% (compared to 72.5% for patients declaring three or more meals per day), with time spent in hypoglycemia maintained well below international recommendations. In addition, no severe metabolic events were observed in this specific patient subgroup.

Advancing Toward a Full Closed-Loop System

The reduction of meal-related user input brings DBLG2 closer to the vision of a “full closed-loop”, where insulin delivery can be fully automated and personalized based on real-time physiological signals, without any user intervention.

“The next frontier for Diabeloop’s research lies in physical activity and movement detection, another key component in glucose variability that remains to be seamlessly integrated into autonomous insulin management. This milestone reinforces Diabeloop’s commitment to innovation centered around patient freedom and well-being. Our teams are already advancing the next generation of sensor-driven features to close the loop on activity and personalized lifestyle adaptation,” added Erik Huneker

About Diabeloop

Founded in 2015, Diabeloop develops artificial intelligence-based solutions to help people living with diabetes automate and personalize their treatment. By connecting continuous glucose monitors (CGMs) and insulin pumps through proprietary self-learning algorithms, Diabeloop enables users to delegate many therapeutic decisions and live with fewer daily interruptions.

DBLG1, Diabeloop’s first marketed system in Europe, has been available since 2021 and is interoperable with Kaleido® (ViCentra), Dana-i® (Sooil), MEDISAFE WITH® (Terumo), and Accu-Chek® Insight (Roche) insulin pumps.

DBLG2 received CE marking under the EU MDR in August 2025 and is currently in its pre-launch phase in Europe, a full launch is planned for early 2026, including Kaleido and Dana-i insulin pumps.

In December 2025, DBLG2 was granted FDA clearance as a Class II Interoperable Automated Glycemic Controller (iAGC). The indication covers people with Type 1 diabetes aged 12 years and older.

For more information, visit Diabeloop.com or send an email at [email protected]

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