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JDRF Forms Partnership with Animas to Develop First-Generation Automated System for Managing Type 1 Diabetes

Jan 15, 2010

This press release is an announcement submitted by JDRF, and was not written by Diabetes Health.

This partnership to develop an automated system represents a first step on the path to producing an artificial pancreas

NEW YORK, January 13, 2010 - The Juvenile Diabetes Research Foundation today announced an innovative partnership with Animas Corporation to develop an automated system to help people with type 1 diabetes better control their disease - the first step on the path to what would be among the most revolutionary advancements in treating type 1 diabetes: the development of an artificial pancreas, a fully automated system to dispense insulin to patients based on real-time changes in blood sugar levels. 

Animas, a Johnson & Johnson company, is a leading manufacturer and distributor of insulin delivery and glucose management systems. JDRF is a global leader in research leading to better treatments and cures for type 1 diabetes. 

The objectives of the partnership, a major industry initiative within the JDRF Artificial Pancreas Project, are to develop an automated system to manage diabetes, conduct extensive clinical trials for safety and efficacy, and submit the product to the U.S. Food and Drug Administration for approval.   

"If successful, the development of this first-generation system would begin the process of automating how people with diabetes manage their blood sugar," said Alan Lewis, PhD, President and Chief Executive Officer of JDRF.  "Ultimately, an artificial pancreas will deliver insulin as needed, minute-by-minute, throughout the day to maintain blood sugars within a target range.  But even this early system could bring dramatic changes in the quality of life for the 3 million people in the U.S. with type 1 diabetes, beginning to free kids and adults from testing, calculating and treating themselves throughout the day." 

Dr. Lewis noted that "JDRF will provide $8 million in funding over the next three years for this project, with a target of having a first-generation system ready for regulatory review within the next four or so years." 

The first-generation system would be partially automated, utilizing an insulin pump connected wirelessly with a continuous glucose monitor (CGM). The CGM continuously reads glucose levels through a sensor with a hair-thin sensor wire inserted just below the skin, typically on the abdomen.  The sensor would transmit those readings to the insulin pump, which delivers insulin through a small tube or patch on the body.  The pump would house a sophisticated computer program that will address safety concerns during the day and night, by helping prevent hypoglycemia and extreme hyperglycemia.  It would slow or stop insulin delivery if it detected blood sugar was going too low and would increase insulin delivery if blood sugar was too high.  For example, the system would automatically discontinue insulin delivery to help prevent hypoglycemia, and then automatically resume insulin delivery based on a specific time interval (i.e., 2 hours) and/or glucose concentration.  It will also automatically increase insulin delivery to reduce the amount of time spent in the hyperglycemic range and return to a pre-set basal rate once glucose concentrations have returned to acceptable levels.

In this early version of an automated diabetes management system, the patient would still need to manually instruct the pump to deliver insulin at times, (i.e. around meals).  But this "hypoglycemia-hyperglycemia minimizer" system would represent a significant step forward in diabetes management, and could provide immediate benefits in terms of blood sugar control, by minimizing dangerous highs and lows.

DexCom, Inc., a leading manufacturer of CGM devices, will supply the CGM technology for the system to be developed by JDRF and Animas.

About Type 1 Diabetes

Type 1 diabetes is an autoimmune disease in which the immune system attacks and kills off the cells in the pancreas that produce insulin, a hormone that enables people to convert food into energy.  It affects children, adolescents, and adults.

To manage their disease, people with type 1 diabetes need to measure their blood sugar multiple times throughout the day (typically by pricking a finger for a drop of blood), and inject themselves with insulin multiple times daily or use an insulin pump to keep blood sugar within a healthy range.  That daily routine continues for life, because insulin does not cure diabetes. 

"Although this partnership is focused on a first-generation system, not a fully automated artificial pancreas, such a system could provide better clinical outcomes for those with type 1 diabetes - reducing if not eliminating the high or low blood sugar problems that send people with diabetes to the hospital, cause accidents or injuries, and make living with diabetes so difficult," explained Aaron Kowalski, Ph.D., Assistant Vice President of for Glucose Control at JDRF and Research Director of the JDRF Artificial Pancreas Project.  "And better control would significantly lower the key risk for developing the devastating long-term complications of the disease, including eye disease, kidney disease, nerve disease or cardiovascular disease."

More information about the JDRF-Animas partnership and the development of a first generation automated system to manage diabetes is available at www.jdrf.org/artificialpancreasproject.  The site also includes information for people with type 1 diabetes about research leading to the development of an artificial pancreas, as well as interactive tools, chats with researchers, and access to information about clinical trials.   

About JDRF

JDRF is the leader in research into a cure for type 1 diabetes and its complications.  It sets the global agenda for diabetes research, and is the largest charitable funder and advocate of diabetes science worldwide.

The mission of JDRF is to find a cure for diabetes and its complications through the support of research.  Type 1 diabetes is an autoimmune disease that strikes children and adults suddenly, and can be fatal.  Until a cure is found, people with type 1 diabetes have to test their blood sugar and give themselves insulin injections multiple times or use a pump - each day, every day of their lives.  And even with that intensive care, insulin is not a cure for diabetes, nor does it prevent its eventual and devastating complications, which may include kidney failure, blindness, heart disease, stroke, and amputation.

JDRF was founded in 1970 by parents of children with type 1 diabetes.  Last year, it funded more than $100 million in diabetes research, in more than 20 countries.  For more information, go to www.jdrf.org.

About JDRF's Artificial Pancreas Project

The JDRF-Animas partnership will build upon the progress made since 2006 in the JDRF-funded Artificial Pancreas Consortium, a group of university-based mathematicians, engineers, and diabetes experts that has developed the computer programs needed for an artificial pancreas, and established their scientific feasibility.  The goal of an artificial pancreas has also been embraced by the U.S. Food and Drug Administration, which along with JDRF and National Institutes of Health, brought together scientists, regulators, industry, and patients for scientific workshops on the subject in 2005 and 2008; the FDA has designated an artificial pancreas as one of its "critical path" initiatives.

Dr. Kowalski noted that the development of an artificial pancreas system is an essential step towards an ultimate cure for type 1 diabetes - a "bridge to a cure."  JDRF's goal is to have multiple versions of an artificial pancreas available for people with diabetes; the organization will continue to explore partnerships with other industry leaders.

* * *

Source: http://www.artificialpancreasproject.com/


Categories: Artificial Pancreas, Blood Sugar, Diabetes, Diabetes, Food, Health Insurance, Insulin, Insulin Pumps, Low Blood Sugar, Type 1 Issues



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Comments

Posted by Anonymous on 16 January 2010

I had thought Medtronic was the leader in this sort of technology. It sounds like someday I'll need to switch to Animas.

Posted by Anonymous on 16 January 2010

The first generation automated system for managing Type I diabetes sounds promising. I am a Type I and have been since 1968. I take 4 injections each day and monitor via cgm 6-8 times per day. I remember cutting an article out in the newspaper dated in 1980 that stated an artificial pancreas or means to transplant beta cells would be developed within the next 10 years. That would have been at least 20 years ago. I find it absurd that given the technological advances in electronics, programming and other areas this "device" could not have been developed many years ago. Three million insulin dependent diabetics require most likely billions of dollars each year in insulin, needles, monitoring machines and test stips that essentially supports an industry. I hate to think that those in the "industry" are more interested in bottom line perpetual profits rather than a "cure" for the disease but it often makes me wonder. The patient cost and care of the results of this eventual devastating disease also supports yet another "industry". It's sad to believe that once again the greed of a few results in the higher costs and devastation of many. Money isn't the root of all evil but rather the love of money that causes the greed that is present in so many areas of our lives today.

WHO, NIH and other organizations should be embarrassed that more research and development has not been completed toward a cure not only for diabetes but other catastrophic diseases as well. We can spend billions of taxpayer dollars to fund a space program yet can't find the money to develop technology that could improve the lives of millions world wide or is the "industry" itself that has priced itself out of the market? I won't even go into how many people worldwide go to bed hungry each night while the billions are wasted on programs that support one "industry" or another.

Posted by Anonymous on 17 January 2010

Why not pick Omnipod or Medtronic??

Posted by Anonymous on 18 January 2010

While I applaud the development of better systems to manage Type 1, I wonder whether this is putting the cart before the horse. In order to create an "artificial pancreas," we need to have insulin that acts promptly like the insulin secreted from a normal pancreas. The fast-acting insulins that we have now are much slower to begin affecting blood glucose and have a longer duration than natural insulin (from what I have read). For example, if the device slows or stops insulin when the blood glucose level goes down, I would expect there to be a spike in the blood glucose following. Then it will take 1.5 - 2 hours to deal with that spike - a recipe for uneven glucose levels.
When I adjust my insulin dosage, I try to take into account what I have eaten during the past two hours, what I anticipate eating, what level of activity I anticipate during the next period of time, and other factors that may not be discernable by the "artificial pancreas." Until we have insulin that acts promptly and has a short duration, I don't think the "artificial pancreas" will be much of an improvement.

Posted by Jody on 18 January 2010

I have been using an insulin pump 722 Paradigm from medtronic. I have been trying to get a cgms due to my hypoglycemic unawareness. Medicare will not cover this. Medtronic will not take payments anad the cost is $1200 for the system, monthly charges to cover the sensors & transmitters runs between $250-$350. With a monthly income of only $800 I am unable to purchase a cgms. Medtronic is running research studies for the cgms as well as the closed loop system aka the Veo Pump. However they will not let me participate bc I am 52 yrs old. They only accept people between the ages of 18-40. I am a type 1 diabetic for 39yrs. The only complication I have is hypoglycemic unawareness. I am a brittle diabetic. A cgms is needed for my survival much like a pacemaker is needed for those who require assistance to send the signal for the heart to beat. It is shameful that Medtronic will not work out payment plans. There only assistance is a one time discount of 10%, whoopie. What a disappointment.
Make it agreat day.
Jody

Posted by Anonymous on 18 January 2010

The artificial Pancreas would be great however to work an insulin that is exactly the same as the body produces would be required.
Today's insulins are too slow and long lasting to enable the system to work. I don't mean to be negative on the idea but being a long time type 1 I know that there are many many variables to overcome
some of which could be life threatening.

Posted by rprice3567 on 18 January 2010

The development of the Artificial sounds like the answer to the type 1 diabetics problems however an insulin would have to be an exact replica of the insulin produced possibly by each individual user.
Todays insulins are too slow and long lasting to work. Everything
in the system would have to be perfectly balanced with each individuals needs. I think that with todays technology they could easily develop the system but to work properly there will be many many variable problems to overcome such as the matching a correct insulin for each user.

Posted by Anonymous on 19 January 2010

The first generation automated system for managing Type I diabetes sounds promising. I am a Type I and have been since 1968. I take 4 injections each day and monitor via cgm 6-8 times per day. I remember cutting an article out in the newspaper dated in 1980 that stated an artificial pancreas or means to transplant beta cells would be developed within the next 10 years. That would have been at least 20 years ago. I find it absurd that given the technological advances in electronics, programming and other areas this "device" could not have been developed many years ago. Three million insulin dependent diabetics require most likely billions of dollars each year in insulin, needles, monitoring machines and test stips that essentially supports an industry. I hate to think that those in the "industry" are more interested in bottom line perpetual profits rather than a "cure" for the disease but it often makes me wonder. The patient cost and care of the results of this eventual devastating disease also supports yet another "industry". It's sad to believe that once again the greed of a few results in the higher costs and devastation of many. Money isn't the root of all evil but rather the love of money that causes the greed that is present in so many areas of our lives today.

WHO, NIH and other organizations should be embarrassed that more research and development has not been completed toward a cure not only for diabetes but other catastrophic diseases as well. We can spend billions of taxpayer dollars to fund a space program yet can't find the money to develop technology that could improve the lives of millions world wide or is the "industry" itself that has priced itself out of the market? I won't even go into how many people worldwide go to bed hungry each night while the billions are wasted on programs that support one "industry" or another.

Posted by Anonymous on 19 February 2010

Another "anonymous" says, [i]I take 4 injections each day and monitor via cgm 6-8 times per day.[/i]

That's not CGM, you're doing fingerpokes. Even the least frequent models of CGMS (the Minimed and Dexcom products) monitor once every 5 minutes. That's 288 per day ;)


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