A clinical study using an artificial pancreatic system showed that it was able to outperform current treatments for people with type 1 diabetes and helped to maintain blood sugar levels throughout the day and overnight.
Linking Tandem Diabetes Care's T: The slim X2 alternative-control insulin pump and Dexcom's continuous G6 blood glucose meter automatically delivers the hormone based on blood glucose and other data without the need for fingersticks or daily injections are.
A one-month study, part of a series funded by the NIH-funded international diabetes closed-loop study, involved 168 participants, ages 1
The Control IQ system helped participants to keep their glucose levels in a healthy range – an average of 2.6 hours per day more than at baseline, while the control group did not gain time.
CONTEXT: The FDA grants Tandem's Plug and Play insulin pump de novo approval. "This artificial pancreatic system has several unique features that enhance glucose control beyond what can be achieved with traditional methods," said co-lead author of the study, Boris Kovatchev, director of the Center for Diabetes Technology The University of Virginia helped develop the algorithms behind the Control IQ system.
"In particular, there is a special safety module to prevent hypoglycemia, and control is gradually stepped up overnight to achieve near-normal blood sugar levels every morning," said Kovatchev.
CONTEXT: The FDA extends the use of Medtronic's & # 39; pancreatic artificial & # 39; and approves the Eversense implantable CGM system.
The study findings were published in the New England Journal of Medicine data to the FDA for review of the Control IQ. The interoperable T: slim X2 pump received a de novo approval last February.
Elsewhere, the Medtronic MiniMed 670G closed system was first approved by the FDA in 2016, but no automated insulin bolus is given. and modulates basal delivery or background insulin instead. It has been called the world's first "closed loop" hybrid system.
According to researchers, the complications associated with diabetes can be lessened by prolonged stay in range. "These results are impressive and clinically relevant as it has been shown that the risk of retinopathy development or progression is reduced by 64% and the risk of developing microalbuminuria by 10% each, 40%," wrote Daniela Bruttomesso University of Padua, Italy, in an accompanying NEJM editorial.
The international closed-label study on Control-IQ is part of a broader research launched at the NIH in 2017 on the safety and efficacy of computer-assisted artificial pancreatic systems and their ease-of-use, impact on patient well-being and overall costs.
Earlier technologies have facilitated the management of type 1 diabetes, and this research shows that this is the case. The artificial pancreatic system has the potential to improve the health of people with type 1 diabetes and at the same time one Relieving much of the caregiver's burden from those affected and their caregivers, "said Proj The scientist Guillermo Arreaza-Rubín, director of the Diabetes Technology Program at the National Institute for Diabetes and Digestive and Kidney Diseases of the NIH.