Diabeloop, a company developing AI-based diabetes management systems, has announced that its DBLG2 has become the first automated insulin delivery system where meal announcements are no longer mandatory to get clearance from the US FDA, as well as a CE Mark, for patients with type 1 diabetes.
A lack of meal announcements can potentially lead to lower glycaemic control. However, Diabeloop’s approach has the advantage of giving people living with diabetes greater choice and autonomy.
Multiple clinical trials have studied the use of non-mandatory meal announcements in insulin delivery. The trials showed that 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 levels of hypoglycaemia and metabolic events were not affected by a lack of meal announcements, although researchers observed significant variance between individuals, showing that a lack of meal announcements may not be effective for all diabetes patients.
For people with type 1 diabetes, mealtimes represent one of the most significant challenges. 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 prioritises 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.
Erik Huneker, co-founder and chief science officer of Diabeloop, said: “Reducing the need for meal-time interventions has been a longstanding goal for automated insulin delivery systems. DBLG2’s ability to adapt in real-time and correct glycaemic excursions even without manual meal input offers patients flexibility in managing their diabetes.”
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.