Four studies backed by the National Institutes of Health have either launched or are poised to launch in the near future. Researchers hope these studies will serve as the potential bridge between testing artificial pancreas systems and requesting regulatory approval for the permanent use of the devices.
Artificial pancreas systems monitor blood glucose levels and provide insulin and other hormones as needed. The systems would replace fingerstick glucose testing and possibly the delivery of insulin by shots or a pump.
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"These studies aim to collect the data necessary to bring artificial pancreas technology to the people who need it," said Guillermo Arreaza-Rubín, MD, director of the diabetes technology program at the National Institute of Diabetes and Digestive and Kidney Diseases. "Results from these studies could change and save lives."
Here are brief descriptions of the four studies.
• The International Diabetes Closed-Loop trial is currently enrolling participants. The study will use smartphones and follow 240 people age 14 and up with type 1 diabetes for six months to test the efficacy of an automated insulin delivery system called inControl.
• Early in 2017, enrollment will begin for a year-long trial of an artificial pancreas in youths aged six to 18 years.
• In late 2017, researchers will compare a hybrid artificial pancreas to a next-generation system programmed for more precise glucose control.
• In 2018, a six-month trial will launch to test the efficacy of a bionic pancreas system equipped with a dual-chamber pump to deliver both insulin and its counteracting hormone, glucagon, to the patient.
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