Diabetics, Rejoice: The Artificial Pancreas Will Soon Be Available
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Diabetics, Rejoice: The Artificial Pancreas Will Soon Be Available

Several devices regulating blood sugar levels autonomously are in final stages before availability

November 11, 2016

There is good news for people suffering from type 1 diabetes: artificial pancreases will soon be able to make their lives much easier, reports Scientific American.

Diabetics with type 1 do not produce the hormone known as insulin. As a result, they must carefully monitor their blood sugar (i.e. glucose) levels. Chronic high levels—the result of too little insulin—can result in damage to nerves and organs; low levels may lead to seizures or even death.

At this time, the best treatment involves a sensor inserted under the patient's skin that continuously monitors glucose levels, a wearable and programmable insulin pump that releases varying amounts of insulin according to the user's needs, and much trial-and-error work on the part of the patient because monitor and pump do not communicate.

Scientists have been trying to find a way to make diabetics' lives easier by integrating and automating this process. The final product—the artificial pancreas—is a system capable of determining the amount of insulin needed by the body almost in real time and then delivering that amount by itself.

Kelly Dunkling Reilly works as a registered nurse and certified diabetes educator, and she also took part in a recent clinical trial of Beta Bionics's iLet pancreas device as a participant. "The artificial pancreas will allow us to live a near-normal life until there is a cure," she said. "For the first time in my 24 years with diabetes, I was able to exercise whenever I wanted and work with my patients without the constant fear of hypoglycemia."

Several artificial pancreas projects that have been in development for almost ten years are advancing into the last stages before becoming available on a widespread basis.

Medtronic filed a premarket-approval application in June with the Food and Drug Administration (FDA) for a device known as a "hybrid closed loop," an insulin pump that receives data from a continuous glucose monitor, analyzes it, and then automatically adjusts the rate of insulin it delivers. Users of this device would still have to input doses to account for meals. A study involving 124 diabetic patients using the device finished in May, indicating that it was safe and trustworthy for autonomously determining doses. The FDA approved the device in September.

Another clinical trial—one of the biggest so far—began at the beginning of the year with 240 participants living across the U.S. and Europe. The trial is being headed by researchers at the University of Virginia and Harvard University, along with several other organizations, and is meant to test the safety and efficacy of a system integrating a pump, a monitor, and a smartphone. The phone depends on an algorithm to analyze blood glucose data and then tells the pump how much insulin to release. The study will test two separate algorithms.

Finally, Beta Bionics is developing a device to administer both insulin and glucagon, the hormone that increases blood glucose. Using data from a monitor, its algorithm determines which hormone to deliver and the amount.

"Using both insulin and glucagon allows for tighter control of blood sugar levels," says CEO Edward Damiano. He hopes that clinical trials testing the device will begin by the middle of 2017, and an insulin-only version could be approved as soon as 2018.