Home Medizin FDA genehmigt neues automatisiertes Insulinabgabesystem für Typ-1-Diabetes

FDA genehmigt neues automatisiertes Insulinabgabesystem für Typ-1-Diabetes

von NFI Redaktion

The automated insulin delivery system (AID) twiist (Sequel Med Tech, LLC; Manchester, NH) has been approved by the US Food and Drug Administration (FDA) for individuals with Type 1 diabetes aged 6 and above.

The system consists of a novel insulin pump developed by Sequel’s research and development partner DEKA, and utilizes the FDA-approved Tidepool Loop algorithm, originally developed through patient-led open-source initiatives.

The twiist AID system is compatible with various integrated continuous glucose monitors (iCGMs), and Sequel will announce its first iCGM partner shortly before the product launch, stated Alan Lotvin, CEO and co-founder of Sequel, as reported by Medical News from Medscape.

It is the first AID system that directly measures the volume and flow of insulin delivery, allowing for quick detection of clogs or blockages, typically within about 20 minutes, Lotvin explained.

Glucose targets can be individually adjusted down to 87 mg/dL. While the system works best when users administer boluses before meals, the algorithm continuously adjusts insulin to bring glucose levels into the target range if they do not. Boluses can be administered via the smartphone app, a smartwatch, or the pump itself.

Sequel plans to make the product available through performance plans for patient pharmacies. „As the product launch draws nearer, we will share more details about additional initiatives aimed at expanding access and simplifying the patient experience,“ Lotvin said.

Miriam E. Tucker is a freelance journalist based in the Washington, DC area. She regularly contributes to Medscape, with additional work appearing in The Washington Post, NPR’s Shots blog, and diaTribe. She can be found on X (formerly Twitter) @MiriamETucker.

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