A clinical trial of an artificial pancreas system showed it was able to outperform current treatments for people with Type 1 diabetes and help maintain blood sugar levels throughout the day as well as overnight.
By linking Tandem Diabetes Care’s T:slim X2 alternate controller-enabled insulin pump with Dexcom’s G6 continuous glucose monitor (CGM), the closed-loop system automatically delivers the hormone based on blood sugar readings and other data without the need for fingerstick draws or daily injections.
The six-month trial—part of a series within the National Institutes of Health (NIH)-funded International Diabetes Closed-Loop study—enrolled 168 participants age 14 and older and followed them in real-world settings. They received either the artificial pancreas system, dubbed Control-IQ, or a sensor-augmented pump and CGM combination that did not automatically adjust insulin delivery.
The Control-IQ system was better at helping participants keep their glucose levels within a healthy range—by an average of 2.6 hours per day compared to the start of the study—while the control group showed no gains in time.
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Additionally, users of the artificial pancreas had fewer moments with spikes or drops in their blood sugar over a 24-hour period, which can be a challenge for sleeping children and adults with Type 1 diabetes.
"This artificial pancreas system has several unique features that improve glucose control beyond what is achievable using traditional methods," said study co-lead author Boris Kovatchev, director of the Center for Diabetes Technology at the University of Virginia, which helped develop the algorithms behind the Control-IQ system.
"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," Kovatchev said.
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The study results were published in The New England Journal of Medicine, and Tandem Diabetes Care has also submitted the data to the FDA for its review of Control-IQ. Its interoperable T:slim X2 pump received de novo clearance this past February.
Elsewhere, Medtronic’s closed-loop system, the MiniMed 670G, was first approved by the FDA in 2016—but it does not administer automated boluses of insulin, and instead modulates basal delivery, or background insulin. It was dubbed the world’s first “hybrid” closed-loop system.
More time spent in-range can reduce the complications that often come with diabetes, according to researchers. “These results are impressive and clinically relevant, since it has been shown that for each 10% reduction in the time spent in the glucose target range, the risk of development or progression of retinopathy increases by 64% and the risk of development of microalbuminuria by 40%,” wrote Daniela Bruttomesso of the University of Padua in Italy in an accompanying NEJM editorial.
The international, closed-loop study of Control-IQ is part of a wider research effort at NIH launched in 2017 to test the safety and efficacy of computer-guided artificial pancreas systems as well as their user-friendliness, effects on patient well-being and total cost.
"Earlier technologies have made the management of Type 1 diabetes easier, and this research shows that this artificial pancreas system has the potential to improve health of people living with Type 1 diabetes, while also potentially lifting much of the burden of care from those with the disease and their caregivers," said project scientist Guillermo Arreaza-Rubín, director of the diabetes technology program at NIH’s National Institute of Diabetes and Digestive and Kidney Diseases.