The FDA has just cleared the first intelligent insulin pump that can automatically administer correction boluses in addition to regulating insulin to prevent high and low blood sugar levels. Tandem Diabetes’ updated t:slim X2 insulin pump works with Dexcom’s G6 continuous glucometer and features Tandem’s new Control-IQ technology that helps to make sure that patients with diabetes stay within the recommended 70-180 mg/dL range as much as possible.
Patients who have an existing t:slim X2 that’s still under warranty can opt-in to receive a free software update that will allow them to take advantage of Control-IQ. This update should be available sometime in January of next year.
Control-IQ relies on the measurements obtained from the Dexcom G6, along with knowledge about how much insulin it knows it already delivered, to accurately predict sugar levels about a half hour into the future. Based on that, the system adjusts how much insulin to provide, and if the prediction is particularly high (over 180 mg/dL), Control-IQ kicks in to calculate how much bolus to administer to get the value down to 110 mg/dL. It then asks the pump to administer 60 percent of that amount every hour until glucose in the blood drops significantly.
Patients can tell the pump about activities they plan on doing, including sleeping and exercise, so that it takes that into consideration and provides appropriate insulin doses.
“Not only do new closed-loop systems need to be effective at improving glycemic control, they must also be easy to understand and use so patients can experience the full benefits of the technology,” said Boris Kovatchev, PhD, Director of the Center for Diabetes Technology at the University of Virginia and principal investigator of the International Diabetes Closed Loop (iDCL) trials, in a press release. “The t:slim X2 insulin pump with Control-IQ technology successfully achieved both objectives in clinical studies. We are very proud of the extensive academic research that went into this effort, and we are thrilled to see this work has translated into an FDA-cleared device for clinical use so that more people can experience the benefits of this technology.”
“With this clearance, we will be launching the most advanced automated insulin dosing system commercially available in the world today,” added John Sheridan, president and CEO of Tandem Diabetes Care. “This is a testament to our commitment to improving the lives of people with diabetes by offering simple-to-use products that deliver superior performance.”
Info page: Control-IQ Technology