FOR IMMEDIATE RELEASE
Contact: Jillian Lubarsky
(212) 479-7626 jlubarsky@jdrf.org
JDRF Forms Partnership with Animas to Develop First-Generation Automated System for Managing Type 1 Diabetes
-- Partnership to develop automated system to better control diabetes represents first step on path to 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.
Wow,this will be life changing ! It is exciting to know this is really going to happen....
Is anyone else a bit disturbed that JDRF is funding AP rather than a cure? This is a topic of much interest on other boards, yet a quick glance here did not show anything. Not only that, but that J&J is so involved in the JDRF and now JDRF is helping to fund something that should be all on J&J.
That is disturbing after all the AP is not a real cure. Our children will not be free of insulin. Im with Dr Faustman, she has some amazing ideas about autoimmunity and type 1
Be careful on writing off this research. Some amazing things have been discovered in the process of developing the AP.
After putting pregnant T1Ds on the AP, their islet cell started reproducing and there have not been off insulin for several months. Why? During pregnancy, the immune system takes a break to protect the fetus. On the AP, which created a very stable BG even after eating high glycemic foods, the pancreas started rebuilding and the islet cells started normal function. After unplugging the AP, they are now not T1Ds and their pancreas is functioning normally.
The math algorithm developed to mimic the normal islet cell response to BG has been successful, so the next step is the sensor. That means that islet cell function and how it interacts with other bio and physiologic events can now be tested, tracked and maybe used to discover why and how the T1D mess starts and at what point the process of developing can be halted or limited or reversed. Or, with technology, maybe the islet cell can emulated by using another bio or man-made structure or component.
Those are some of what I know about the AP project. For those of us who have had this crap for years (40 for me) this is the first tangible mastery of T1D.
Thank you to all involved, JDRF, JJ, the institutions and all the people!!!Do you have links where I can see the pregnant research? I have not heard that anywhere before.
No kidding... I haven't heard about any of this either. What source are you using?
just because they're funding the ap doesn't mean they don't also have money going towards other research for a cure. a cure isn't just around the corner, nor is it going to pop up suddenly just because money is thrown towards it (though, it certainly can't hurt). while i'm waiting for a cure, i like seeing advances in treatment. of course, i'm always hopeful a cure will happen soon, i'm also practical about it. to me, advances in treating the disease also puts us one step closer to curing it.
I think I can safely say that we all appreciate advancements in treatment. BUT, as a prior fundraising parent for the JDRF, AP is not a cure. We are raising money for a cure. AP will be very profitable for the companies that market it. Do they need our research money to fund it, no way. It is especially questionable when Johnson and Johnson has representation on the JDRF board, as well as a representative of a stem cell company (both major areas of JDRF interest, maybe not by coincidence, you make the call.)
On top of that is the matter of who will be able to afford this technology? I know that at this point, we will not. Medicaid doesn't pay for cgms let alone this supposed AP. A cure should be something that all diabetics should have available. If not, what is the point? Have you watched the movie Life for a Child? It does no good for these children in poverty ridden countries if they have zero access to it.
By posting this here, I was really hoping to get a response from the JDRF. They have a PR nightmare on their hands with a large portion of their fundraising base.
I am very happy to see advances in technology that will help us handle diabetes better, but I would rather see my money raised going towards a cure.
In the last 7 years since my child was diagnosed, we have raised nearly $40,000 for JDRF. Last year my fundraising efforts have been redirected to research that is looking for a cure, not just better technology.
We don't know how far away a cure is.The Artificial Pancreas gives hope soon of better health for our children and all those with type1. Better Health till the cure is here ! This news is one of the best things this parent has heard.......
I'm with you meme. The better shape a T1D is in, no matter what there age them better chance they have for have a cure work for them.
I have been raising money and volunteering for JDRF for over 38 years and as a now "adult" T1D any thing that could free me from the BG, insulin calculations, hypos, hypers and the general stress of managing this challenge is a step closer to a cure.
I attended a talk by one of the Dr's in working in the AP development studies and he old me on the value of having the AP. the resulting knowledge and technical development and the surprising things that have come out of the studies that will have a direct impact on the health and everyday treatment of T1D. Everything from autoimmune revelations to mathematical mode;ing of the function of the pancreas.
The AP development is about much more that giving someone an AP, so I cheer JDRF for taking the gutsy move to fund a project that had been screaming for money to move forward for years.
Here is he JDRF Research newsletter link JDRF Research
Don't you think that the pump companies have been waiting for the technology to be able to move forward more than the money? The way I see it, pump companies are raking in the dough. It will only continue when AP becomes a reality. They have the funds to finance this!
I understand that some of you have put your whole heart into JDRF. You probably can't even see this from another perspective. I don't have nearly the years into the JDRF as some of you. We are just celebrating 10 years. But, in your quiet moments alone, just think about it for a minute. This is a disservice to our children with this disease and our adults that have fought this for years. This technology would have come along with or without the JDRF.
You have to admit there are too many conflicts in interests to not question this.
Can someone answer this question: When Animas starts making money off this project, will JDRF reap the rewards?
I agree that the pump compnaies have the funds available to fund advancements in technology without the hekp of JDRF, and they will be profiting plenty when the AP becomes available. Even with an AP, my child will still need to check blood sugar, and go on in life having diabetes.
The thing that bothers me is the connection bewteen JDRF and J&J...I don't find it a coincidence. I too used to be happy with just hearing good news and not really reading into it to see what is actually behind it.
I would honestly like to know why JDRF has decided to partner with Animas. I find it rather disturbing that JDRF has partnered JUST with Animas, a Johnson and Johnson company. The heir to Johnson and Johnson was the CEO of JDRF. Why hasn't JDRF partnered with the other companies, minimed, omnipod, the navigator. Minimed is the ONLY pump/cgms company to have an intergrated cgms, this is a very important and valuable part to the AP. I don't mind having advances in technology, our kids need advances. What I DO mind is JDRF partnering with a company that has obvious connections and stands to make HUGE amounts of money. This partnership should have taken place between ALL pump and cgms companies. What I smell stinks. They aren't thinking about our children and a cure. They are thinking about more technology and more money. :(
[quote user="WestinsMom"]
Don't you think that the pump companies have been waiting for the technology to be able to move forward more than the money? The way I see it, pump companies are raking in the dough. It will only continue when AP becomes a reality. They have the funds to finance this!
I understand that some of you have put your whole heart into JDRF. You probably can't even see this from another perspective. I don't have nearly the years into the JDRF as some of you. We are just celebrating 10 years. But, in your quiet moments alone, just think about it for a minute. This is a disservice to our children with this disease and our adults that have fought this for years. This technology would have come along with or without the JDRF.
You have to admit there are too many conflicts in interests to not question this.
Can someone answer this question: When Animas starts making money off this project, will JDRF reap the rewards?
[/quote]
Westinsmom,
You seem very angry about your child's T1. That is completely normal, but maybe you have some feelings to work through? I applaud your efforts to encourage research for a cure! But, for those of us who have been waiting for a cure for year after year after year, the advances in treatment are helping to keep us alive. When I was diagnosed, I used huge needles, was on a strict meal plan, had to inject 30 min before eating, and had no home testing meter, only urine testing. I was often in the hospital for the first couple of years until we had reliable home glucose testing. I am grateful for the advances we have, even though it's certainly awful to wait and hope for a cure. Maybe you can put some of your energies into raising money and lobbying for research for a cure? I just want to make sure we all support each other on here even if we disagree about details of current research or JDRF b/c we're all in this T1 thing together!! Thanks.
Ok, so I'm assuming animas is going to come out with a CGM before this comes out? If not, I will be very reluctant to buy it if I cant first see if this is accurate and trustworthy. I agree that the cure is not around the corner so we should work on better technologies. WHat is described is not a full ap. what i want, is something i can tuck away untilthe next infusion set change. one of the biggest reasons that my mom and dad were pushing me to get a minimed pump is that they are on the cutting edge of technologie, as they describe it. it turns out that, the cgm is VERY accurate and trustworthy and the companie is very helpful when you phone for help. this is an advancement for animas but im concerned that theyre leaping too far to the next stone in the river.
there seems to be some strong opinions on this
Animas is suppose to be intergrating their 2020 (NOT PING) with the dexcom sensor.. They don't have their own, they are partnering with dexcom.
JDRF prides itself on being the #1 NON-PROFIT organization in the WORLD for diabetes research for a cure. More technology is needed. We've come a HUGE way.. something that my child is greatly benefitting from. But do you feel comfortable that JDRF Animas/dexcom consider the AP a CURE??? I surely don't! I have raised thousands and thousands of dollars for JDRF for a CURE.
What I find horrifing is the obvious connection between JDRF and Animas (johnson and Johnson.) What I want to know is WHY JDRF partnered with Animas and only animas. ITs a HUGE conflict of interest when the CEO of JDRF is the heir to Johnson and Johnson, the ONE company that JDRF decided to work with for the AP?
Honestly, the ONE company that JDRF should have been looking into is Minimed, they are the ONLY pump company to have the intergrated cgms. They also have a pump out in UK that automatically shuts off when the bg is detected at 50 or below. This is a HUGE step towards the AP... WHY did JDRF go with a company that doesn't even have this technology in their pump?
There is NO problem with the AP, there is no problem better technology. I see a HUGE GIGANTIC problem with JDRF partnering themselves with the ONE company that stands to make JDRF's (former)CEO Large amounts of money. And the one company that is currently being sued for getting large kickbacks from insurance companies.