Diabeloop and Sequel Med Tech Enter Partnership to Integrate FDA-Cleared DBLG2 into the twiist™ Automated Insulin Delivery System
GRENOBLE, France & Manchester, New Hampshire, U.S. - January 14, 2026 - Following the U.S. Food and Drug Administration (FDA) 510(k) clearance granted December 18, 2025 for DBLG2 as an Interoperable Automated Glycemic Controller (iAGC), Diabeloop and Sequel Med Tech today announce 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 U.S. 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 U.S. 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 U.S. 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 U.S. 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.
About the DBLG Algorithm:
Simplicity, Personalization, and a Step Closer to Full Closed LoopThe DBLG algorithm is designed to reduce the mental burden of diabetes management while delivering strong glycemic 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.
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 approved 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]
About twiist
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.
For more information about twiist, please visit?www.twiist.com.
About Sequel Med Tech
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. Its FDA-cleared innovation, the twiist® Automated Insulin Delivery (AID) system, integrates novel technologies to reimagine insulin delivery and sets a new standard for drug delivery. Sequel is bringing the latest developments in science and technology to help drive more accessible drug delivery.
For more information, visit?sequelmedtech.com?and?twiist.com.
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