FDA clears twiist Automted Insulin Delivery System

      The US Food and Drug Administration has cleared the twiist automated insulin delivery (AID) system developed by Sequel Med Tech. for people aged 6 years or older with type 1 diabetes. It is the first insulin pump to integrate with the FDA approved Tidepool Loop algorithm, originally developed through patient-led, open-source initiatives. The system consists of Deka insulin pump, Tidepool Loop algorithm and a CGM sensor. The twiist AID system works interchangeably with different integrated continuous glucose monitors (iCGMs). Specifically, twiist measures both the volume (amount) and flow (speed) of each micro-dose of insulin. This allows for more personalization of insulin dosing, which could allow for more precise glycemic control and improved health benefits. With the Tidepool Loop algorithm, people who use the twiist AID system can set targets as low as 87 mg/dL which is considerably lower than the standard target of 110 mg/dL that is pre-specified by other insulin pump companies. The twiist AID system is also the first FDA approved AID system that can be directly controlled by an Apple Watch.