New Insulin Delivery System: For People with Type-1 Diabetes Approved by FDA

Good news for people with Type-1 diabetes! A new automated software system, which lets them customizes the treatment and automatically adjusts the insulin levels, has just been approved for use by the Food and Drug Administration. It will reach patients in January 2020.


Tandem Diabetes Care has engineered the technology, called Control-IQ. The device is an integration of blood glucose sensors and insulin pumps that automatically increases, decreases, or stops the delivery of insulin in response to the glucose levels for people with Type 1 diabetes. People with this type of diabetes do not produce insulin, a hormone that controls and regulates blood sugar (glucose); therefore, they need to consume it from an external source every day. The current scenario is that many patients have to manually adjust and readjust the amount of insulin they receive throughout the day. The new Control-IQ uses a closed-loop system, which adjusts the input automatically upon a change in output. Thus, allowing the users to rely on the device rather than taking insulin manually.

According to a publication in The New England Journal of Medicine; people with Type 1 diabetes using Control-IQ with Tandem’s t-slim X2 insulin pump had fewer instances of unregulated blood sugar and spent more time with blood sugar levels within their targeted range than those who manually adjusted the insulin.

Patients can Personalize their System 

Other closed-loop systems have also received FDA approval. However, the software used in the Control-IQ can be “interoperable”, which means that the users are not bound to use products by Tandem Diabetes Care. They can build a personalized system using other sensors and pumps that have the same designation from the FDA.

Control-IQ can be used with Tandem Diabetes Care’s t: slim X2 insulin pump, which was approved as interoperable in February 2019, and Dexcom Inc’s G6 continuous glucose monitor, which was designated as interoperable in 2018.

The software system can automatically deliver a corrective dose of fast-acting insulin if it detects that a user’s blood sugar levels are too high. This process sets it apart from other closed-loop systems available in the market, which steadily delivers a slow dose of insulin, known as a basal rate, to keep blood sugar levels constant but don’t automatically deliver corrective doses. Medtronic, a medical device company, was the first to release a closed-loop system in the market. It is now testing an addition of the same feature to their device.

What’s even better is that the people who use Tandem’s t-slim X2 insulin pump will be automatically upgraded to the new system for free in January 2020.

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