FDA approves first artificial pancreas

Luis Britez
Science & Tech Correspondent

The wait for an artificial pancreas to finally hit the market is now over, as the Food and Drug Administration recently approved a device by Medtronic to help combat Type I diabetes. Medtronic, a leading manufacturer in insulin pumps, was given the nod by the FDA on Sept. 28 to bring their device to the market.

The rapid approval was gladly received by many, including visionary tech entrepreneur Jeffrey Brewer, founder of Bigfoot Biomedical. “Medtronic’s approval is very good news for us,” Brewer, a leading advocator in the effort to bring an artificial pancreas to the market, told Discover. “It shows that the FDA understands the need for these devices and isn’t going to delay their approval.

Type I diabetes is a disease where the pancreas cannot produce enough insulin, which leads to an increase in glucose levels, or sugar. This can increase the risk of nerve and kidney damage, along with heart disease and other complications in the body.
The MiniMed 670G hybrid closed-loop system, the artificial pancreas developed by Medtronic, underwent testing by the FDA two weeks prior to their approval. The study saw positive results. People were able to control their blood-sugar range 72 percent of the time with Medtronic’s device, compared to 67 percent of the time when controlling their own insulin dosing.

The device which controls Type I diabetes combines both an insulin pump and a continuous glucose monitor that measures blood-sugar levels at all times. It is as small as a cellphone and worn externally, with thin tubing inserted underneath the skin and replaced every few days. The device is not fully automatic, however, with users being required to type in the amount of carbohydrates they consume every meal. The device then calculates and delivers the correct amount of insulin to the person based on their current blood-sugar level and prior history of responses.

Medtronic’s device isn’t the only artificial pancreas that was developed. Jeffrey Brewer and Bigfoot Biomedical are hoping to get permission from the FDA to have their device released to the market. Bigfoot’s artificial pancreas, in contrast to Medtronic’s own, doesn’t require inserting the amount of carbohydrates consumed, though it does require an alert for each meal. This will be done by entering the information on a smart phone using Bluetooth and a data transmitter that instructs the artificial pancreas’ actions.

Brewer hopes to obtain approval for his innovation by next summer and for it to be on the shelves by 2018.
Others, such as Beta Bionics and Professor Kovatchev from the University of Virginia, have received hefty grants and crowd funding to develop their own devices and to later conduct trials.

With the amount of companies waiting to manufacture, test and seek approval from the FDA, this will provide healthy competition amongst the companies in the near future. The ultimate goal, nevertheless, is to provide the public with a new, safe and efficient device that can ultimately save their lives.

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