FDA Releases New Guidelines to Speed Up Artificial Pancreas Development
December 2, 2011 1:32 PM
comment(s) - last by
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FDA has released new guidelines meant to speed up the development and testing of these products, which were based on a draft guidance on safety and effectiveness goals in developing the Low Glucose Suspend System back in June.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.
This article is over a month old, voting and posting comments is disabled
RE: Is it just me...
12/2/2011 11:50:32 PM
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 once...it'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
"I f***ing cannot play Halo 2 multiplayer. I cannot do it." -- Bungie Technical Lead Chris Butcher
Did You Partake in "Black Friday/Thursday"?
Did You Partake in "Black Friday/Thursday"?
I skipped Thanksgiving to get the Black Thursday deals!
I spent Thanksgiving with friends/family, but I lined up at midnight for the deals!
Skip Thanksgiving? Wait in line? No way, but I'll go out today and see what's left.
I prefer Cyber Monday.
I don't do deal shopping... too much stress, it just isn't worth it.
Tiffany's Holiday Gift Guide
November 22, 2011, 5:42 PM
Testicular Tissue May be Used to Grow Insulin in Men with Type 1 Diabetes
December 13, 2010, 10:05 AM
Artificial Pancreas Shows Promise for Type 1 Diabetes Patients
April 18, 2010, 6:06 PM
Some Dark Side For Your Black Friday: Official Star Wars Ep. VII Trailer Lands
November 28, 2014, 1:02 PM
U.S. Air Force F-35 Lightning II, F-22 Raptor Team Up for “Integration Training”
November 19, 2014, 9:15 AM
U.S. Marshals Using Fake, Airplane-based Cell Towers to Scan Cell Phones of Americans
November 14, 2014, 9:05 AM
Ford Enlists Wind Energy Corp. to Provide Wind, Solar Energy to Four U.S. Dealerships
November 10, 2014, 10:58 AM
Disney Reveals Star Wars Ep. VII Title -- "The Force Awakens"
November 6, 2014, 3:45 PM
U.S. Navy Lockheed F-35C Completes First Carrier Landing
November 4, 2014, 12:44 PM
Most Popular Articles
Hack of Sony Pictures Indicates Employees Were Pirating Blu-Rays
November 25, 2014, 4:00 PM
Google Caves to Microsoft and Apple's Pet "Patent Troll" Rockstar
November 24, 2014, 3:30 PM
Some High-End Luxury Watchmakers Crack Down Hard on Smartwatch Faces
November 26, 2014, 1:28 AM
Report: Samsung Galaxy S5 Sales Have Come in 40% Below Projections
November 24, 2014, 6:58 AM
Xiaomi Aims to be #1 Smartphone OEM Within 10 Years, Apple Urges Caution
November 21, 2014, 9:33 AM
Latest Blog Posts
Costco Gives Employees Thanksgiving Off; Wal-Mart Leads "Black Thursday" Charge
Oct 29, 2014, 9:57 PM
"Bear Selfies" Fad Could Turn Deadly, Warn Nevada Wildlife Officials
Oct 28, 2014, 12:00 PM
The Surface Mini That Was Never Released Gets "Hands On" Treatment
Sep 26, 2014, 8:22 AM
ISIS Imposes Ban on Teaching Evolution in Iraq
Sep 17, 2014, 5:22 PM
Space Terrorism is a Looming Threat For the United States
Apr 23, 2014, 7:47 PM
More Blog Posts
Copyright 2014 DailyTech LLC. -
Terms, Conditions & Privacy Information