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Following the US Food and Drug Administration (FDA) 510(k) clearance granted December 18, 2025 for DBLG2 as an Interoperable Automated Glycaemic Controller (iAGC), Diabeloop and Sequel Med Tech announced a collaboration through which Diabeloop’s DBLG2 algorithm will be integrated into Sequel’s twiist Automated Insulin Delivery (AID) system. The integrated system will initially be available in the US market, with potential expansion to other countries at a later stage.
By integrating the DBLG2 algorithm from Diabeloop the partnership moves Sequel’s twiist Automated Insulin Delivery (AID) System closer to a fully closed-loop solution.
The shared objective is to deliver proven clinical outcomes, ease of use, and advanced personalization while continuing to give people with type 1 diabetes confidence they are receiving the insulin expected. This will be the first integration of the Diabeloop algorithm into a commercial insulin pump in the US market, reinforcing Diabeloop’s strategy to partner with innovative pump manufacturers to expand user choice and access to interoperable AID technologies.
François Miceli, chief executive officer of Diabeloop, commented: “We are thrilled to have this agreement with Sequel Med Tech for their new generation of Automated Insulin Delivery systems built around the twiist insulin delivery system. This partnership represents a significant step forward, as it will provide the US diabetes community with access to our technology for the first time.
Together with Sequel, we are determined to develop an AID system that meaningfully simplifies diabetes management without compromising clinical outcomes. This collaboration further confirms our position as a leading AID algorithm partner for pump manufacturers seeking to address both the US and European markets. It is also our fifth official insulin pump integration, following Roche, ViCentra, Terumo, and Sooil.”
Alan Lotvin added: “We recognize type 1 diabetes is not one size fits all, and diabetes technology shouldn’t be either. That’s why twiist is committed to give people as much choice as possible. twiist will be the only AID system with multiple algorithm options, so people can personalize their care as they desire. The twiist AID system empowers people to get the insulin they need, when they need it, so they can reach their goals while living with greater freedom and more flexibility.”
The DBLG algorithm is designed to reduce the mental burden of diabetes management while delivering strong glycaemic outcomes. By analyzing continuous glucose data in real time, it automatically adjusts insulin delivery to maintain glucose levels within a target range.
A core objective of the DBLG algorithm is simplicity at initiation combined with deep personalization. To get started, users only need to enter their body weight and total daily insulin dose. From there, the system continuously adapts to the individual.
Built with a self-learning module, the algorithm refines its parameters over time based on glucose trends and insulin delivery history, enabling it to respond to the diversity of Type 1 diabetes physiologies, specific medical conditions, and personal preferences.
DBLG2 represents a further step toward full closed-loop insulin delivery. Users may choose not to declare meals; in this case, DBLG2 continues to manage glucose automatically, although optimal control is achieved when meals are declared.
The twiist AID System is the first insulin delivery system that directly measures the volume of insulin delivered with every micro-dose. Cleared for people ages six and up with type 1 diabetes, the twiist AID System offers the capability and flexibility to address each person’s individual dosing needs. The twiist Loop algorithm, based on the diabetes community-driven?Tidepool Loop, allows the system to automatically adjust basal insulin delivery based on real-time sensor readings and predicted glucose levels.
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.
Headquartered in?Manchester, N.H.,?Sequel Med Tech, LLC?is developing the next generation of transformative drug-delivery advancements. Sequel’s approach is to look at disease management holistically to advance systems that make living with disease simpler and easier for all.
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