Beta Bionics has received approval from the US Food and Drug Administration (FDA) for its iLet ACE Pump and iLet Dosing Decision Software to treat people with type 1 diabetes aged six years and above.
The pump and the software, accompanied by a compatible integrated continuous glucose monitor (iCGM), are part of a new system called iLet Bionic Pancreas.
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For determining and controlling insulin delivery, the new automated insulin dosing (AID) system deploys an algorithm.
The FDA’s Centre for Devices and Radiological Health director Dr Jeff Shuren said: “Today’s action will provide the type 1 diabetes community with additional options and flexibilities for diabetes management and may help to broaden the reach of AID technology.
“The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance like diabetes through precision medicine approaches.”
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An adaptive closed-loop algorithm, which starts with the user’s body weight and eliminates the need for additional insulin-dosing parameters, is utilised by the iLet Bionic Pancreas. It offers a simpler initiation process compared to other existing AID systems.
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By GlobalDataWith its innovative meal announcement feature, the iLet device streamlines the mealtime process by eliminating the need for traditional carb counting.
The latest feature enables users to assess the number of carbs in their meal, categorising it as small, medium or large.
For achieving each user’s insulin requirements, the algorithm also continually adapts and refines its responses.
The iLet Dosing Decision Software operates autonomously based on information received from the integrated iCGM system, making decisions to adjust basal insulin doses, including increasing, decreasing, maintaining or suspending them.
