“Automated insulin dosing” is the term for an advanced sensor-enabled insulin pump system with three key parts. A CGM sensor sends information about your patient’s glucose to a “controller,” which is a process or set of instructions using advanced math to solve a task. The controller automatically calculates real-time adjustments to your patient’s insulin in an effort to reduce highs and lows, and automatically sends a command to their insulin pump as often as every five minutes to change how much insulin is being delivered.
Though it was once referred to as an “artificial pancreas,” automated insulin dosing does not involve an implanted device and is not a biological cure for diabetes. In recent years, many people with diabetes have been using insulin automation to help them manage their diabetes.
What that means: the pump is designed to work safely with more than one type of controller or algorithm that adjusts insulin.
What that means: The algorithm (computing logic) has been designed to communicate with other compatible diabetes device components in a modular system.
This controller software might be embedded in the insulin pump itself, run from a separate handheld device, or even live inside a smartphone app.
What that means: the CGM system meets FDA’s criteria for accuracy and safety for dosing insulin.
Built on the extraordinary foundation of the do-it-yourself diabetes community’s original Loop app, Tidepool Loop is a first-of-its-kind project with the goal to take through FDA and bring to market cutting edge user-led innovations borne from this #WeAreNotWaiting community of innovators with the support of best-in-class medical device partners.
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