FDA Releases New Guidelines to Speed Up Artificial Pancreas Development
December 2, 2011 1:32 PM
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Artificial pancreas devices are not a cure, but combine a glucometer and insulin pump to make the lives of type 1 diabetics easier
In an effort to speed up the development of
artificial pancreas systems
for type 1 diabetes treatment, the U.S. Food and Drug Administration (FDA) issued new guidelines Thursday that could give researchers and industry more flexibility in creating safe and effective diabetic devices.
Type 1 diabetes is the result of the pancreas creating little to no insulin, which is a hormone required to control blood sugar. Type 1 diabetics typically control their blood sugar by testing blood glucose levels via a glucometer, and then use a syringe or insulin pump
to appropriately inject the correct amount of insulin needed.
But now, artificial pancreas devices are meant to make life easier for type 1 diabetics. The system combines an insulin pump and a glucometer via a sensor underneath the skin, which works continuously while in the body. The glucometer checks blood glucose levels and communicates these numbers to the insulin pump, which then distributes the correct
amount of insulin
to keep blood sugar at a normal range.
The FDA has released new guidelines meant to speed up the development and testing of these products, which were based on a draft guidance on safety and effectiveness goals in developing the Low Glucose Suspend System back in June.
"We really are trying to get these devices to the market as quickly as possible," said Charles Zimliki, leader of the FDA's Artificial Pancreas Working Groups and Critical Path Initiative. "Hopefully it [approval for one or more devices] will happen sooner rather than later.
As a person with type 1 diabetes
, I hope it happens tomorrow."
The guidelines offer recommendations on how to conduct testing, but are more flexible when it comes to number of patients involved, the length of the study and study goals. This will make it easier for researchers to put a safe and effective device on the market sooner.
There's no clear date when the first artificial pancreas will be available, but there are definitely a few obstacles that need to be addressed before a device can hit the market including software issues, problems creating algorithms to send insulin that take into account the period of time needed for the body to absorb it, the need for faster-acting insulin, and the need to occasionally recalibrate blood sugar monitors.
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Weren't some exploits published for these devices?
12/2/2011 2:08:23 PM
I'm pretty certain I've heard of some exploits that would allow an attacker to control the insulin pump and/or sugar level sensor on these types of devices over wireless.
Speeding up development is fine, but security on these things needs to be scrutinized heavily.
RE: Weren't some exploits published for these devices?
12/2/2011 4:02:48 PM
There are plenty of easier ways to kill someone "wirelessly".
RE: Weren't some exploits published for these devices?
12/4/2011 2:59:57 AM
Ive heard something else from someone diabetic... that almost everyone who was in articles about insulin pumps are now dead..
a few years later.
this of course, is not the same as those in the article, i guess it can't be since its not on the market yet.
"Intel is investing heavily (think gazillions of dollars and bazillions of engineering man hours) in resources to create an Intel host controllers spec in order to speed time to market of the USB 3.0 technology." -- Intel blogger Nick Knupffer
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