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FDA Attempts to Speed Development of Artificial Pancreas

By December 21, 2011

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The U.S. Food and Drug Administration (FDA) recently issued new guidelines toward trying to speed up the development of an effective artificial pancreas device. This is welcome news to people with type 1 diabetes who have been hearing about technological advances toward an artificial pancreas for years but are still waiting for a significant breakthrough.

The new guidelines allow for more flexibility in how clinical trials are conducted along with opening channels of communication between those in academia and those in research to streamline the testing process with fewer regulations to inhibit the pathway to clinical studies. This would include allowing data from clinical studies outside the U.S. to be used in the approval process. Currently, there are 20 FDA approved clinical studies specifically on the artificial pancreas. These new guidelines would hopefully allow many more over a shorter period of time.

The artificial pancreas combines current technologies for continuous blood glucose monitoring and insulin pumps to deliver insulin as needed. The goal is for the device to accurately read the blood sugar and automatically dispense the precise amount of insulin needed to keep the blood sugar in a normal range.

There is still no projected time frame for when an artificial pancreas might become available. There are still several key problems that haven't been solved, which include creating consistently reliable algorithms to deliver insulin in a variety of situations.

Do you think an FDA approved artificial pancreas will become available in the next five years? Why or why not? Post your comments below.

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December 22, 2011 at 1:55 am
(1) Chandra Prakash from India says:

An artificial pancreas is definitely a great hope for Type 1. However stem cell therapy would be out there in a couple of years, and it will definitely wipe out this awkward diabetes “poking and checking and piercing and delivering” business forever, and I keep praying for that everyday. Come pray with me you all diabetes world people, a complete cure is nearing…….

December 22, 2011 at 2:49 pm
(2) Karen says:

I have had Type I for 38 yrs. now, I am 43 and been waiting on the 5 year mark for that cure for over 30 years now, I am disapponted to say. Personally, I think the industry makes too much money right now on Type I insulin dependent diabetes supplies, etc. for the FDA to approve a cure even if there is one. Don’t mean to sound negative, but this was actually happening in some of the medical industries in the US in many areas that is the US stayed behind other countries. My mother use to say she would fly me to anywhere in the world if a cure actually did come forth, but she has since passed away. I have now been diagnosed with Vascular Dimentia caused by Diabetes at 43. Granted, I am fortunate I had all the laser surgeries I could have done to my eyes and saved my vision for the most part, but legally blind in left eye from surgery complications and fortunate that for the time being my kidneys function. I just can’t remember what I did five minutes ago. I just hope I live long enough to see a cure and know what it is and still know who I am, if I don’t pass altother first. Had a friend on a pump, was an RN who had Type I since age three and passed from a heart attack at 42. So I do have to say I am grateful to be alive too, just don’t know if I will make it another 5 years and if they would get on with the Stem Cell Research, I agree, I think we could see something with it much faster, I have read about actual cures, even if only for a temperary period of time to repeat the treatment, just no FDA approval.

December 22, 2011 at 4:02 pm
(3) Roy Hansen says:

I recently have gone to the TCOYD conferences for the past 2 years and this was a very big topic of disscusion. I would also like to see more research into the monitoring of blood sugar with a new device called glysends (not sure of spelling), in which a sensor the size of a gran of rice is inserted under the skin that uses similar technology that the CGM system uses but the sensor is good for one year without replacement. It has passed a trial in a pig for almost 500 days without failure, Clinical trails in humans to follow. This is a CGM device. I’ve been a type 1 for 15 years with lat adult onset at age 37. I have gone on a pump 2 years ago. I welcome this aftifical pancreas project and hope for a release in 5 yrs or less.

December 29, 2011 at 12:06 pm
(4) Firoz says:

FDA will not be approve that easy. This is very big indudtry to make tons of money. They will approve only if there is another big jiant deceases like diabetec come in pic.

December 29, 2011 at 2:46 pm
(5) David says:

That sounds great, doesn’t it? But I definitely agree with the point that: THE CURE HAS BEEN HOLDING BACK by the Medical industry and governament (whos make money out of tax and other avenues from the medical field) they try to blind us with “a better treatment”…”better insulin”…”pumps”…tis and that. Really? We’re sick of that, of course we’re so thank full for all the technology out there, but now is TIME, the cure is possible, i’m sure about that, for how long our lifes will be holded by those Medicals Industries? We’re done with that… NOW IS TIME TO STOP DIABETES!

January 1, 2012 at 11:28 am
(6) Chandra Prakash from India says:

Great comments from everyone. I just read today that 27 million Americans are already diabetic and another 56 million are pre-diabetic, that is they definitely are potential diabetics. If this is the case in a developed and one of the most medically advanced countries in the world, imagine the rest of the world. Thinking business in diabetes is committing crime against (27 + 56) million Americans. 83 million is a huge number and Americans cannot allow Diabetes to ruin the lives of 1/3rd of the total population. They need to press the government for getting a cure out (most of the diabetics know that their condition has a complete cure somewhere), its just held by governments so that medical revenues are not hit. This cannot be accepted, we cannot let ourselves be killed. We need to protest and let our voice be heard.

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