FDA clears first-ever artificial pancreas for automated insulin delivery
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.