Diabeloop and Sequel Med Tech have announced a strategic collaboration following FDA 510(k) clearance for DBLG2 on December 18, 2025.
The agreement integrates Diabeloop’s DBLG2 algorithm into Sequel’s twiist Automated Insulin Delivery (AID) system. The integrated system will launch in the US market first, with potential international expansion later.
What the FDA Clearance Enables?
DBLG2 was cleared as an Interoperable Automated Glycaemic Controller (iAGC).
This clearance allows:
- Integration with compatible insulin pumps
- Greater flexibility across AID ecosystems
- Faster innovation through modular AID components
The partnership moves twiist closer to a fully closed-loop insulin delivery system.
Why This Integration Matters?
This marks the first commercial integration of the Diabeloop algorithm in a US insulin pump. The collaboration focuses on three priorities:
- Proven clinical outcomes
- Ease of use
- Deep personalization for people with type 1 diabetes
Diabeloop continues its strategy of partnering with pump manufacturers to expand user choice.
Executive Perspective
François Miceli, CEO of Diabeloop, called the partnership a major milestone. He emphasized:
- First US access to Diabeloop technology
- Simplified diabetes management
- No compromise on clinical performance
This becomes Diabeloop’s fifth official pump integration, after Roche, ViCentra, Terumo, and Sooil.
twiist’s Differentiated Approach
According to Sequel Med Tech’s Alan Lotvin, diabetes technology must adapt to individuals. The twiist AID system stands out by offering:
- Multiple algorithm options
- User-driven personalization
- Flexibility across different diabetes needs
twiist aims to give users more freedom without sacrificing glucose control.
How the DBLG2 Algorithm Works?
DBLG2 is designed to reduce the mental burden of diabetes management. Key features include:
- Real-time analysis of CGM data
- Automatic insulin adjustments
- Focus on keeping glucose within target range
Initialization is intentionally simple.
Users enter only:
- Body weight
- Total daily insulin dose
From there, the system learns continuously.
Self-Learning and Personalization
DBLG2 includes a self-learning module. Over time, it adapts based on:
- Glucose trends
- Insulin delivery history
- Individual physiology and preferences
This allows the algorithm to respond to diverse Type 1 diabetes profiles.
Moving Toward Full Closed-Loop Control
DBLG2 supports optional meal declaration.
- Users may skip meal announcements
- The system continues automated glucose management
- Best control is achieved when meals are declared
This flexibility pushes the system closer to true closed-loop operation.
About the twiist AID System
The twiist AID System introduces a unique technical capability. It is the first insulin delivery system to:
- Directly measure insulin volume per micro-dose
Additional highlights:
- Cleared for ages six and up
- Adapts dosing to individual needs
- Uses the community-driven Tidepool Loop–based algorithm
Basal insulin is adjusted automatically using predicted glucose levels.
Company Snapshots
Diabeloop: Founded in 2015, Diabeloop develops AI-driven diabetes automation solutions.
Its algorithms connect CGMs and pumps to reduce daily treatment decisions.
Sequel Med Tech: Headquartered in Manchester, New Hampshire.
Focused on next-generation drug delivery systems that simplify disease management.
Bottom Line
This collaboration brings Diabeloop’s adaptive algorithm to the US pump market for the first time. For people with type 1 diabetes, it signals:
- More choice
- Greater personalization
- A step closer to fully automated insulin delivery
