Jan 12, 2016 12:47 AM EST
Diabetics may soon have a smarter diabetes management assistant, thanks to a new smartphone-based system that can automatically control blood-sugar levels. A device developed by researchers from the University of Virginia School of Medicine that allows an automatic monitoring and regulation of the blood-sugar levels in people with type 1 diabetes will undergo final testing in two clinical trials. Trials will start early this year.
A smartphone, designed with a tiny sensor and wearable insulin pump, can substitute for the pancreas to monitor blood-sugar levels and deliver insulin as needed, researchers said. “We’ve been working on this artificial pancreas as it’s called since 2006,” lead researcher Boris Kovatchev, director of the UVA Center for Diabetes Technology, disclosed.
This artificial pancreas is designed to eliminate the need for people with type 1 diabetes to stick their fingers a number of times daily to check their blood-sugar levels and to inject insulin manually. With the artificial pancreas, insulin will be delivered as needed.
The system, which is named “InControl,” works with a readily available blood-glucose sensor. This is about the size of a flash drive and can be worn in any of part of the body-- such as an arm, leg, or the abdomen. Every five minutes, the sensor reads blood-glucose levels and wirelessly reports the results to a specially designed app on a nearby android smartphone.
The app’s algorithm analyses the data and wirelessly controls a discreet, wearable insulin pump, which can be hooked to a belt or other piece of clothing. The pump has a very fine needle that delivers the required amount of insulin into the blood stream. As people with the artificial pancreas can likewise access assistance through telemedicine, confidence on the use of this app will not be an issue.
UVA reports that the researchers are gearing up for two final stages of trials, designed in collaboration with the Food and Drug Administration. These trials will take place at nine locations in the U.S and Europe. Funds amounting to more than $12.6 million were granted to the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health to support the study. The first phase, which has been identified as the International Diabetes Closed-Loop trial, will test the system developed by Dr. Kovatchev’s team, current director of the UVA Center for Diabetes Technology. TypeZero Technologies, a startup company in Charlottesville that has licensed the UVA system, and further refined the system for clinical use, will collect further safety and efficacy data on Kovatchev’s original design and algorithm from 240 patients. Once the first phase of the testing is concluded, 180 of the 240 patients will continue with another test, this time using Doyle's improved algorithm. Each test will be conducted within a six-month period.
If the so-called artificial pancreas system performs in patients as hoped, it could lead to commercial trials as well as a possible regulatory approval in the locally and abroad. The researchers anticipate having the trials completed in four years.
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