Print 9 comment(s) - last by radium69.. on Dec 5 at 3:23 AM

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FDA has released new guidelines meant to speed up the development and testing of these products, which were based on a draft guidance on safety and effectiveness goals in developing the Low Glucose Suspend System back in June.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.

Source: WebMD

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Is it just me...
By MrBlastman on 12/2/2011 1:50:34 PM , Rating: 2
Or does that picture of a trim, washboard tummied model with a insulin pump on her belly remind me of those Catheter commercials on TV?

Yes, yes it does.

You know those annoying ads, the ones where this young nurse comes on the TV and says: "This is a catheter," while holding it up to the camera with a smile. She's then followed by some attractive looking woman who says something on the lines of, "I love my catheter!" With a friendly wink.

Yeah, THOSE commercials. Ugh. Catheters on TV--and they're sexy, TOO!


Sorry to be tangental, but, well, I couldn't help it.

RE: Is it just me...
By Breathless on 12/2/2011 6:03:52 PM , Rating: 3
Yea... but aren't you glad they chose the attractive skinny girl for this picture instead of a cellulite bean bag belly jelly role horse woman picture representative of probably 70 percent of the women in america?

RE: Is it just me...
By ThisSpaceForRent on 12/2/2011 11:50:32 PM , Rating: 3
I like my women like I like my chicken, with a 'lil bit of fat on the end...more cushion for the pushing?

And besides isn't closer to 50% who are tons of fun? Everyone goes whaling at least's like riding a moped, fun to do, but you don't want to be seen by your friends...etc etc etc.

What was this article about? Pumping things? giggity

RE: Is it just me...
By rodrigu3 on 12/4/2011 12:40:01 PM , Rating: 2
Have you ever even seen a Type I diabetic? They are thin. Type II diabetes is caused by obesity+genetics. Type I diabetes is an autoimmune disorder.

RE: Is it just me...
By radium69 on 12/5/2011 3:23:21 AM , Rating: 2
Have you ever even seen a Type I diabetic? They are thin. Type II diabetes is caused by obesity+genetics. Type I diabetes is an autoimmune disorder.

Yes, myself for example.
I have Type I diabetes. It's been 11 years since they diagnosed me with Diabetes type 1 (I'm 21 now). Nearly died 2 times, 1st time when they diagnosed me just on time, and the 2nd time when I wasn't able to control it anymore and went into a coma because of hyperglycimia. My pancreas makes NO insuline at all and I have to inject 4 times a day 356days a year, for the rest of my life until there is a solution.

I weigh 195pounds and am 1.81m or roughly 6 feet tall.
And you are wrong to say they are thin at all.
The insulin you inject makes you a bit thicker also.
................................................. ......

Would be glad if they continued research to find an option.
You can live with diabetes, but it's a pita, and you have to take precations with EVERYTHING. Also, with type 1 you need to have a steady and balanced life to control everything between the lines. Life is not like that at all.

Weren't some exploits published for these devices?
By Etsp on 12/2/2011 2:08:23 PM , Rating: 2
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.

By invidious on 12/2/2011 4:02:48 PM , Rating: 2
There are plenty of easier ways to kill someone "wirelessly".

By Silver2k7 on 12/4/2011 2:59:57 AM , Rating: 2
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.

Going way out on a limb here
By YashBudini on 12/4/2011 8:30:30 PM , Rating: 3
I think the old dude in the photo, Wilford Brimley, does commercials for type 2 diabetes treatments.

He was in John Carpenter's The Thing. So if he had type 2 diabetes at that time did The Thing also end up with it?

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