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Closed-loop artificial pancreas from Tandem, Dexcom aces type 1 diabetes study



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

68 participants age 14 and older and followed them into real-world settings. They received either an artificial pancreas system, dubbed Control-IQ, or a sensor-augmented pump and a CGM combination that did not automatically adjust insulin delivery.

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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.

RELATED: FDA grants de novo clearance to Tandem's plug-and-play insulin pump

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.

RELATED: FDA expands use of Medtronic's 'artificial pancreas,' approves Eversense's implantable CGM system

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.


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