A clinical trial of an artificial pancreas system showed that it was able to outperform current treatments for people with type 1 diabetes, and helped 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, the closed-loop system automatically divides the hormones based on blood sugar readings and other data, without the need for fingerstick draws or daily injections.
month trial — part of a series within the NIH-funded International Diabetes Closed-Loop Study — enrolled 1
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 more compared to the start of the study, while the control group showed no gains in time.
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Additionally, users of artificial pancreas had few moments with spikes or drops in their blood sugar over a 24-
"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 the prevention of hypoglycemia, and there is a 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 provided to the FDA for its review of Control-IQ. Its interoperable T: slim X2 pump received a new clearing this past February.
Elsewhere, Medtronic's closed-loop system, the MiniMed 670G, was first approved by the FDA in 2016 — but it doesn't administer automated insulin boluses, 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 can come with diabetes, according to researchers. “These results are impressive and clinically relevant, as it has been shown that for each 10% reduction in time spent in the glucose target range, the risk of development or progression of retinopathy increases by 64% and the risk of microalbuminuria development by 40%, ”wrote Daniela Bruttomesso, of the University of Padua, Italy, in an accompanying NEJM editorial.
The international, closed-loop study of Control-IQ is part of a broader 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 wellbeing and total cost.
"Earlier technologies have made management of type 1 diabetes easier, and this research shows that this the artificial pancreas system has the potential to improve the 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 proj ect scientist Guillermo Arreaza-Rubín, director of the diabetes technology program at the NIH's National Institute of Diabetes and Digestive and Kidney Diseases.