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Success! FDA Agrees to Accelerate Artificial Pancreas Technology

Success! FDA Agrees to Accelerate Artificial Pancreas Technology


The FDA has agreed to move forward with accelerating the development of an artificial pancreas that could free children and adults with type 1 diabetes from painful injections. In just 23 days, over 100,000 people — including Care2 members who signed this petition — joined together to call for swift action on the creation of artificial pancreas technology.

The artificial pancreas is an external device. People with  type 1 diabetes could use it to “do what their bodies cannot — control both high and low blood sugar around the clock.” The device has both a continuous glucose monitor (CGM) and an insulin pump which, via sophisticated computer software, can provide the right amount of insulin at the right time and automatically. With such a device, those with type 1 diabetes would be “freed from the daily burden of managing the disease.”

Senator Susan Collins (R-ME) noted that, just last week, results from an outpatient trial of an artificial pancreas were announced in France and Italy. Clinical experts have described the artificial pancreas as nothing less than than the most “revolutionary development in diabetes care since the discovery of insulin.”

The FDA is to issue guidance for research into this potentially life-changing technology by December 1.

At a press conference, Jeffrey Brewer, President and CEO of the Juvenile Diabetes Research Foundation , an organization dedicated to finding a cure for type 1 diabetes, described the artificial pancreas as a “life saving and game changing device for kids and adults living with type 1 diabetes” and encouraged the FDA to issue guidance that will adopt leading clinical researchers’ recommendations, lest there be delays in patient access to the new technology. Senator Collins and Senator Jeanne Shaheen (D-NH) also asked the FDA to take into serious consideration recommendations recently put forth by leading clinical organizations regarding the guidance about the artificial pancreas, in order to “avoid the shortcomings of the recently proposed guidance for Low Glucose Suspend Systems, an AP precursor technology.”

Type 1 diabetes accounts for 5% of all cases of diabetes; it is an autoimmune disease whose cause may be genetic, environmental or other factors. While usually diagnosed in children and young adults, it can occur at any age. The majority of those with diabetes have type 2 diabetes, which is linked to older age, obesity, physical inactivity, family history of type 2 diabetes and a personal history of gestational diabetes, according to the Center for Disease Control and Prevention. Currently, 25.8 million Americans — about 8.3% of the population — have diabetes (type 1 or type 2), with 7  million having the condition while being unaware of it.

The CDC says that those with  diabetes have “shorter life expectancy and about twice the risk of dying on any given day as a person of similar age without diabetes.” The need to accelerate research into promising new technologies like the artificial pancreas for those with type 1 diabetes is extremely urgent. Τhanks to the advocacy of people with type 1 diabetes, clinical experts, politicians and Care2 members, this new device could soon become a reality and make a difference in the lives of many.


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4:43AM PST on Jan 21, 2012

This progress is laudable. We should set our minds straight about the causes for type 2 diabetes, however, and not continue to listen to the CDC and other medical groups saying life style is the main factor for this disease. Causes also lie in the way our food is industrially manufactured (hidden sugars, corn syrup etc.), certain medications (credible scientific studies are finding that taking statins (cholesterol-lowering drugs) can increase risk for type 2 diabetes, especially in women), and pollutants such as pesticides.

4:12AM PST on Jan 19, 2012


10:12PM PST on Jan 18, 2012

I'm one of those people who will benefit from this combination of EXISTING TECHNOLOGY. I do not understand why there is a delay: the CGM is a proven technology, and external insulin pumps have been in use for over 30 years. My poor scarred and calloused fingers will be very grateful! It's not quite as exciting as the prospect of actually regrowing active islet cells from stem cells, but I'll take anything that may make the act of living every day with insulin-dependent diabetes (rather than dying from it) a little less complicated. This will NOT be a mindless device, and will require that TWO stylets and cannulas be inserted (and left in place under the skin) every 3 days (or so), and will require that the user become familiar and comfortable with the devices and their software. It won't be "idiot-proof", and will still present great challenges for diabetic people who have significant visual impairment. It is NOT a cure. But this combined device beats the h**l out of multiple fingerstabs and injections every day.
I've been doing this every day for 45 YEARS, and have in my lifetime gone from using a glass syringe that had to be boiled along with needles that had to be sharpened, to a pump. I had already been diabetic for 20 years when I got my first glucose meter. I have all my fingers and toes, and all my kidneys and eyes, and 2 1/2 grandchildren, and still have my fat butt! I wish there were a CURE in the works, rather than just more portable blood glucose monitorin

5:55PM PST on Jan 17, 2012

Thanks for great news

4:51PM PST on Jan 16, 2012

Looking forward to more success!

11:22AM PST on Jan 16, 2012

Oh PLEASE yes PLEASE!! My family has a history of type II diabetes...(my great-great grandmother died from it, and my father, despite being in great shape and eating well has it though it's mostly managed now thru diet and exercise) and my mother's side of the family has a history of PCOS (which I have inherited) that means insulin resistance. My husband is a type II diabetic, and so my daughter has it genetically pre-dispositioned on both sides of the family. (My MIL died due to complications from her uncontrolled blood sugar when my daughter was 6. After beating cancer 3 separate times; twice breast once melanoma on the bottom of her foot, she died while on dialysis, with her heart working at only 33%. And my daughter who is homeschooled has 2 "classmates" who have type I diabetes. It would be so wonderful to be able to free those kids.

It would be wonderful to know my daughter shouldn't need to fear for her future.

7:50AM PST on Jan 15, 2012

This is wonderful news! Let's hope it leads to a great solution to this problem very quickly!

6:34AM PST on Jan 15, 2012

Good news for many people.

4:53AM PST on Jan 15, 2012

Thanks for great news

1:55AM PST on Jan 15, 2012


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