FDA approves new closed-loop insulin delivery system for people with Type 1 diabetes

A new software system that will let people with diabetes customize their treatment and automatically adjust their insulin levels was just approved for use by the Food and Drug Administration. It will reach patients in January 2020.

The technology, called Control-IQ, is manufactured by Tandem Diabetes Care and connects with blood glucose sensors and insulin pumps to automatically increase, decrease, or stop the delivery of insulin in response to the glucose levels of people with Type 1 diabetes. People with Type 1 diabetes can’t produce their own insulin, which regulates blood sugar (aka glucose), so they need to take it from an external source every day. Currently, many patients with diabetes have to manually adjust and readjust the amount of insulin they receive throughout the day. With this kind of device, called a closed-loop system, users can instead rely on the device to adjust as needed.

People with Type 1 diabetes using Control-IQ with Tandem’s t:slim X2 insulin pump had fewer instances of high or low blood sugar than people manually adjusting the insulin, according to a six-month clinical trial recently published in The New England Journal of Medicine. Those patients also spent more time with blood sugar levels within their targeted range.

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