Medical

FDA clears first-ever artificial pancreas for automated insulin delivery

FDA clears first-ever artifici...
For the first time, the US Food and Drug Administration (FDA) has approved a so-called artificial pancreas designed to both monitor and inject insulin automatically, requiring minimal input from the user
For the first time, the US Food and Drug Administration (FDA) has approved a so-called artificial pancreas designed to both monitor and inject insulin automatically, requiring minimal input from the user
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For the first time, the US Food and Drug Administration (FDA) has approved a so-called artificial pancreas designed to both monitor and inject insulin automatically, requiring minimal input from the user
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For the first time, the US Food and Drug Administration (FDA) has approved a so-called artificial pancreas designed to both monitor and inject insulin automatically, requiring minimal input from the user

Monitoring blood-glucose levels and injecting insulin to keep them in a safe range is a never-ending headache for sufferers of type 1 diabetes. A number of research projects have made promising steps recently to promise easier ways of doing things, and now this type of convenience is set to move out of the lab and into the real-world. For the first time, the US Food and Drug Administration (FDA) has approved a so-called artificial pancreas designed to both monitor and inject insulin automatically, requiring minimal input from the user.

In a healthy person, beta cells in the pancreas secrete vital insulin, which in turn regulates blood-sugar levels. But for sufferers of type 1 diabetes, this process breaks down along the way, requiring them to administer finger-prick blood tests to keep tabs on their insulin levels and inject the hormone as required.

For years, scientists have been exploring better ways to keep the condition in check. These have included implanting beta cells, tracking glucose levels through contact lenses and ways insulin can be delivered via a capsule rather than a needle. But perhaps the most attractive solution is what is known as a closed-loop system, which seeks to automate both monitoring and administration of insulin to dramatically reduce the burden on the user.

Generally speaking, these artificial pancreases consist of an externally-worn pump that partner with a sensor inside a needle that is inserted under the skin. This sensor continuously monitors blood-glucose levels and prompts the pump to release insulin as required. A study earlier this year that assessed the progress of this technology concluded that they could be available in as little as two years, but it seems that things are moving faster than expected.

The FDA yesterday approved the MiniMed 670g hybrid closed-looped system developed by Medtronic, the same company that last year unveiled the world's smallest pacemaker. A sensor takes glucose measurements every five minutes and insulin is taken from a pump attached to the body and delivered via a catheter as required, automatically keeping blood-glucose in check.

The approval follows a clinical trial where MiniMed 670G was used by 123 patients with type 1 diabetes for a period of three months, following a two-week period of not using it. The FDA concluded that the device is safe for people 14 and over and no dangerous effects were observed. Trials are currently underway assessing its safety for children aged seven to 13.

"This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

Source: FDA, Medtronic

2 comments
zr2s10
Wow, next best thing to a cure! If not for the inconvenience, it probably works better than most people's natural pancreas, lol. I'll be sure to pass this on to my dad. He's been type 1 since age 13. He uses a dosing "pod" right now, which is much better than the shots, but the auto glucose checking would be a great addition.
EE_Tim
Hmm... I remember, back in 1979 or 1980, when I was a Biomedical Engineering student, at the University of Iowa, going to a lecture about an implantable device called the artificial pancreas. It would monitor the users glucose levels and supply small amounts of insulin, from an internal reservoir. The implant contained a small bladder that held the insulin and could be refilled through and injection port. The electronics kept a running history of usage that the doctor could access. It contained a built in radio transceiver that communicated to an external device. The external device used an acoustic coupler that allowed a doctor to remotely monitor the device, retrieve the history and make dosing changes over an ordinary phone line. I thought that it was way ahead of its time. Over the years I wondered why I never anything about it coming on the market. Maybe the FDA never granted it's approval? Maybe it was too cost prohibited to make? Maybe insurance companies would not pay for the cost of the device when there were much cheaper ways to keep ones diabetes under control.