The results of a six-month test of an artificial pancreas system have just been reported in The New England Journal of Medicine, and the findings are impressive.
The artificial pancreas system combines two devices from two companies. The first device is the t:slim X2 insulin pump made by Tandem Diabetes Care, a San Diego-based company that specializes in products for diabetes patients. The t:slim X2 is equipped with a feature called Basal-IQ, which looks 30 minutes ahead and suspends insulin delivery to help lessen the time and frequency of episodes of hypoglycemia (low blood sugar). Employing Basal-IQ technology requires the use of a continuous glucose monitor (CGM), which is where the second device comes in. The CGM used in the trial was the G6 Continuous Glucose Monitoring (CGM) System, a product of Dexcom, a company that has been researching long-term implantable sensors for some two decades. The combination of the two devices is called the Control-IQ system.
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To test the Control-IQ artificial pancreas, the researchers enlisted 168 people with type 1 diabetes aged 14 and over and randomly assigned them to use either the Control-IQ system or a combination of a CGM and an insulin pump that didn’t automatically adjust insulin. The researchers found that users of Control-IQ increased the amount of time that their blood sugar levels were in the target range by an average of 2.6 hours per day. The patients also showed improvements in HbA1c (a measure of glucose control over the previous 2 to 3 months) and had fewer episodes when their blood sugar was too high or too low.
Boris Kovatchev, PhD, lead author of the study, said the Control-IQ system has “several unique features that improve glucose control beyond what is achievable using traditional methods. In particular, there is a special safety module dedicated to prevention of hypoglycemia and there is gradually intensified control overnight to achieve near-normal blood sugar levels every morning.” Griffin P. Rodgers, MD, director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which provided the bulk of the funding for the trial, commented, “Artificial pancreas technology has tremendous potential to improve the day-to-day lives of people with type 1 diabetes. By making management of type 1 diabetes easier and more precise, this technology could reduce the daily burden of the disease while also potentially reducing diabetes complications, including eye, nerve and kidney disease.”
When the study was complete, Tandem Diabetes Care announced it had submitted the results to the U.S. Food and Drug Administration (FDA) with the intention of securing approval for the Control IQ system.
Want to learn more about artificial pancreas systems? Read “Four Crucial Artificial Pancreas Trials Getting Underway,” “Artificial Pancreas for Type 1 Diabetes Receives FDA Approval” and our “Artificial Pancreas” definition.
A freelance writer and editor based in the Chicago area, Gustaitis has a degree in journalism from Columbia University.