The U.S. Food and Drug Administration (FDA) on Friday approved the use of a new closed-loop insulin delivery system that allows diabetics to customize treatments and automatically adjust insulin levels,media outlet The Verge reported. It will reach the patient in January 2020.
The technology, called Control-IQ, is manufactured by Tandem Diabetes Care and is connected to blood glucose sensors and insulin pumps to automatically increase, reduce or stop insulin delivery based on blood sugar levels in patients with type 1 diabetes. People with type 1 diabetes are unable to produce their own insulin to regulate blood sugar(also known as glucose), so they need to get insulin from an external source every day. Currently, many people with diabetes have to manually adjust and readjust the amount of insulin they receive throughout the day. Using a device called a closed-loop system, users can instead rely on the device to adjust as needed.
According to a recent paper published in the New England Journal of Medicine, a six-month clinical trial showed that people with type 1 diabetes with Control-IQ and Tandem’s t-slim X2 insulin pumps had fewer cases of high or low blood sugar than those who manually regulated insulin. These patients also spend more time with blood sugar levels within the target range.
Other closed-loop systems have also been approved by the FDA. One of the main differences with the software is that it is considered “interoperable”. This means that users will not be locked out using the product by Tandem Diabetes Care. They can build personalized systems using other FDA-approved sensors and pumps.
Control-IQ is currently available for use with Tandem Diabetes Care’s t:slim X2 insulin pump, which was approved for interoperability in February 2019, while Dexcom Inc’s G6 continuous glucose monitor was designated interoperable in 2018.
If the software system determines that the user’s blood sugar level is too high, it can also automatically provide the correct dose of quick-acting insulin. This distinguishes it from other closed-loop systems on the market, which provide continuous low-dose insulin (known as a base dose) to keep blood sugar levels stable, but do not automatically provide a corrected dose. Medtronic, a medical device company with its first closed-loop system on the market, is now testing the add-on features of its devices.
Users of Tandem’s t:slim X2 insulin pump will automatically upgrade to the new system in January 2020 for free.