Sunday, January 31, 2010
tallygear tummietote'......
Donna has been working on this design for a long time and had modified things as we have gone along....and everything makes this pack better and better. She has started selling them at her sites http://www.tallygear.com/ and http://www.insulinpumppack.com/ .
Anyway, she cut a window into one of the pockets to view the screen on the paradigm. My Neice has in a matter of a few short weeks , come to rely on the window. She doesn't even have to remove the pump from the pocket. She hasn't even updated the website to include this option so if you go there and are interested in one send her an email and she will contact you back to get your specific needs.
The best we can do with this condition until they find a cure is to LIVE GOOD......I will post a picture of view window in belt in the next day or two.
As always
LIVE GOOD,deb
new mini-med real time transmitter and glucose sensor
this thing looks amazing, but i will bet it is expensive.....
MiniLink™ REAL-Time TransmitterThe MiniLink REAL-Time Transmitter—the part of the MiniMed Paradigm® REAL-Time System that transmits data from the glucose sensor to the insulin pump—delivers distinct advantages:
Comfortable
Discreet
Waterproof
Long-lasting
Ultra-sleek design requires very little skin "real estate."
The MiniLink REAL-Time Transmitter is comfortable
The comfortable MiniLink REAL-Time Transmitter is about the size of a quarter.
Tiny: 1.4" x 1.1" x 0.3"
Lightweight: less than 1/4 ounce
Ergonomically shaped to move with you—it won't tug, pull, or pinch
Small adhesive area: 1.5" x 0.8"—about the size of a postage stamp
About the size of a quarter
The MiniLink REAL-Time Transmitter is discreet
The MiniLink Transmitter has an ultra-sleek, thin profile. It lies nearly flat, without a bulge. Wireless, it works virtually anywhere on your body, under any clothing.
About as thin as 4 quarters
The MiniLink REAL-Time Transmitter is waterproof
Wear your transmitter and glucose sensor while swimming, bathing, or showering. Fully immersible, you can wear it to a depth of eight feet for up to 30 minutes.
Freedom to enjoy water activities*
* While MiniMed Paradigm® Insulin Pumps are water-resistant and designed to protect against splashes and occasional dunking, Medtronic Diabetes recommends that no insulin pump be intentionally submerged in water.
The MiniLink REAL-Time Transmitter is long-lasting
For long-term use, and for your convenience, the MiniLink REAL-Time Transmitter is rechargeable.
A quick 20-minute recharge lasts up to three days of continuous use. The full recharge lasts up to 14 days of continuous use.
The MiniLink REAL-Time Transmitter kit includes the transmitter, charger, and tester.
MiniLink™ REAL-Time TransmitterThe MiniLink REAL-Time Transmitter—the part of the MiniMed Paradigm® REAL-Time System that transmits data from the glucose sensor to the insulin pump—delivers distinct advantages:
Comfortable
Discreet
Waterproof
Long-lasting
Ultra-sleek design requires very little skin "real estate."
The MiniLink REAL-Time Transmitter is comfortable
The comfortable MiniLink REAL-Time Transmitter is about the size of a quarter.
Tiny: 1.4" x 1.1" x 0.3"
Lightweight: less than 1/4 ounce
Ergonomically shaped to move with you—it won't tug, pull, or pinch
Small adhesive area: 1.5" x 0.8"—about the size of a postage stamp
About the size of a quarter
The MiniLink REAL-Time Transmitter is discreet
The MiniLink Transmitter has an ultra-sleek, thin profile. It lies nearly flat, without a bulge. Wireless, it works virtually anywhere on your body, under any clothing.
About as thin as 4 quarters
The MiniLink REAL-Time Transmitter is waterproof
Wear your transmitter and glucose sensor while swimming, bathing, or showering. Fully immersible, you can wear it to a depth of eight feet for up to 30 minutes.
Freedom to enjoy water activities*
* While MiniMed Paradigm® Insulin Pumps are water-resistant and designed to protect against splashes and occasional dunking, Medtronic Diabetes recommends that no insulin pump be intentionally submerged in water.
The MiniLink REAL-Time Transmitter is long-lasting
For long-term use, and for your convenience, the MiniLink REAL-Time Transmitter is rechargeable.
A quick 20-minute recharge lasts up to three days of continuous use. The full recharge lasts up to 14 days of continuous use.
The MiniLink REAL-Time Transmitter kit includes the transmitter, charger, and tester.
Thursday, January 28, 2010
SURFING WITH TYPE 1
Surfing with Type 1
Rob Blase
Aug 7, 2009
Initially diagnosed with type 2 diabetes, Rob subsequently discovered that he had type 1. Knowing that he needed to exercise more, he returned to professional surfing. Today, he is a sponsored professional athlete who uses a CGM.
In 2007, I was feeling a little off. I gradually lost about 30 pounds without trying. My vision was a little blurry, but I just assumed that it was caused by outdated contact lenses. I needed to visit the bathroom numerous times a night, and I was extremely tired. I blamed it all on starting a new job during the summer of 2007, but my wife finally convinced me to see my doctor for a checkup. I went in expecting to learn that I had a bladder infection or something minor, but I was in for a big surprise.
A few minutes after I gave my physician a urine sample, he came back and said, "I have good news and bad news!" The good news was that I did not have a bladder infection. The bad news was that my glucose level was 575. The doctor followed up with an A1c test, which showed 14.5%. Luckily for me, my body was flushing out the excess sugar so effectively that I did not have any of the complications experienced by many recently diagnosed people. The initial diagnosis was type 2 diabetes, and I was given a prescription of Janumet. It was also suggested that I follow up with a nutritionist and an endocrinologist.
I went home and told my wife. Neither of us could understand how a healthy person in his late thirties with no family history could have type 2. I am not overweight, not sedentary, and I eat a healthy diet. But instead of feeling sorry for myself and wasting time trying to figure out "Why me?" my wife and I did tons of research on exactly how we could beat this disease. Because I had been told that I was type 2, we came up with an even healthier diet and added exercise that we hoped would help control the disease.
My wife followed up per the doctor's suggestion and first called the nutritionist. After she told the nutritionist everything that was going on, the nutritionist suggested that I might have been misdiagnosed and that maybe I really had type 1 diabetes. She advised me to consult with an endocrinologist as soon as possible, but the endocrinologist could not fit me in until a week later. In the meantime, my wife and I met with the nutritionist and a certified diabetes educator (CDE). We arrived with our diabetic binder that contained all of our research, including lab results, print/web articles, and my detailed diet plan. The nutritionist was very impressed that we had come up with such an aggressive and structured plan so quickly. She did tell us, however, that she still believed that I had type 1, not type 2, and that we should keep that in mind.
My initial consultation with the endocrinologist was really nothing much. He evaluated the initial lab results, my diet plan, and the medications I was taking, and he ordered more tests to see what was really going on. A follow-up meeting with the endocrinologist was set for two weeks later, and I went in for additional blood work in the interim. As the days went by, my numbers did start to improve, but my health deteriorated more and more. The final two days before the endocrinologist appointment, I was not able to keep any food down and I felt horrible.
At the follow-up visit with my endocrinologist, he confirmed that I had type 1 diabetes. That explained why I felt so horrible. I was immediately prescribed insulin and sent on my way. Like all newly diagnosed people with type 1, I took a few weeks to get the dosages and numbers to the point where I needed them. After that, I began looking for a new challenge.
Back in the 1980s, I used to surf both as an amateur and as a professional. Throughout the intervening years, however, my life changed, and so did my priorities. Because I didn't make a bundle of money surfing, I had to settle down and get a real job. Along the way I also got married and had two wonderful sons, ages 18 and eight. Now that I had this new disease, however, I decided that working toward competing again would be an excellent form of exercise to help my diabetes. With that, I started surfing again, four to five times a week.
Exercising presented me with a couple of new challenges. I found that every time I surfed, my blood glucose (BG) level dropped very quickly. I would go from 120 to the low 60s in a matter of 60 minutes. Consequently, I learned to go into the water a little higher. I also always have a surfing buddy, just to make sure that I have support should anything go wrong or should I ever go too low. Passing out in the water is a whole lot more dangerous than passing out on dry land.
It wasn't long before I, like most competitive people, got the itch to step up my surfing game and get back into competition. Things were going really well for me at this point. I had all the support in the world from my family and sponsors. My numbers were getting better, and I was getting good results in surfing contests. Still, I wanted better BG numbers and as low an A1c as possible. For that reason, my wife and I started researching insulin pumps just three months after my diagnosis. We ended up going with Medtronic's Minimed insulin pump, and we began working toward getting the continuous glucose monitor (CGM) that works with the pump.
A couple of reasons were behind our decision. For one, another surfer was already using a Medtronic, and he loved it. For another, the company was working on a waterproof housing so that the device could be worn in the water. Last but not least, I would not have to carry a second device if I used Medtronic's CGM to monitor my BG levels 24/7. The Minimed not only delivers insulin, but also works wirelessly to collect and store all the BG levels from the CGM. Because I am an information technology manager by trade, I always like having as much data as possible.
I was approved immediately for the Medtronic Minimed insulin pump, and within 30 days I had my CGM as well. (Anthem BlueCross is my primary healthcare insurer and United Healthcare is my secondary.)
As with all new devices, a learning curve is involved. However, with help from the rep, the endocrinologist, and my very smart and supportive wife, we got everything dialed in within a week or two. After 90 days on the pump and using the CGM for additional information, I was able to get my A1c down from 14% to an amazing 6.3%. Today (about one year out) I have an A1c of 5.7%, but I remain committed to keeping my numbers low by testing six to eight times a day, eating right, and exercising often.
I am continuing to have great success surfing, thanks to sponsorship support from Medtronic, Bessell Surf, Fast Blue Communications, JETPILOT Clothing & Wetsuits, Freestyle Watches, Spy Optics, H2O Audio, Globe Shoes, Kicker Audio, Bubble Gum Surf Wax, Drop In Ride Shop, and BioNutritional Research Group. I am even going to do a few pro events this year.
One of my requirements of my surfing sponsors is that they must be willing to give me stickers, clothes, and other gadgets. When my wife and I visit the diabetic wards in hospitals, we hand out all the goodies to the kids. There is nothing more rewarding then giving a child some free stuff and seeing that smile on her face when she realizes that somebody out there cares and is successfully living with the same disease.
When people find out that I have diabetes, I often hear them say, "Sorry to hear about your disease," or "Oh man, that is a slow death sentence." However, I look at it from the opposite perspective. I am happy to share my story and educate people that having diabetes doesn't make me different from anybody else, except that I probably eat better and live healthier then most people!
Because I was always an athlete, I used to take my health for granted. I rarely went to the doctor, and I pretty much ate and drank what I wanted. Diabetes actually came into my life at just the right time (in my late thirties) to help me start eating healthier and get on a regular exercise program. But the number one thing that has helped me keep my disease under control has been the love and support of my wonderful wife and family. It's a team effort. With support, anything is possible!
Very Inspiring.....
LIVE GOOD,
deb
Rob Blase
Aug 7, 2009
Initially diagnosed with type 2 diabetes, Rob subsequently discovered that he had type 1. Knowing that he needed to exercise more, he returned to professional surfing. Today, he is a sponsored professional athlete who uses a CGM.
In 2007, I was feeling a little off. I gradually lost about 30 pounds without trying. My vision was a little blurry, but I just assumed that it was caused by outdated contact lenses. I needed to visit the bathroom numerous times a night, and I was extremely tired. I blamed it all on starting a new job during the summer of 2007, but my wife finally convinced me to see my doctor for a checkup. I went in expecting to learn that I had a bladder infection or something minor, but I was in for a big surprise.
A few minutes after I gave my physician a urine sample, he came back and said, "I have good news and bad news!" The good news was that I did not have a bladder infection. The bad news was that my glucose level was 575. The doctor followed up with an A1c test, which showed 14.5%. Luckily for me, my body was flushing out the excess sugar so effectively that I did not have any of the complications experienced by many recently diagnosed people. The initial diagnosis was type 2 diabetes, and I was given a prescription of Janumet. It was also suggested that I follow up with a nutritionist and an endocrinologist.
I went home and told my wife. Neither of us could understand how a healthy person in his late thirties with no family history could have type 2. I am not overweight, not sedentary, and I eat a healthy diet. But instead of feeling sorry for myself and wasting time trying to figure out "Why me?" my wife and I did tons of research on exactly how we could beat this disease. Because I had been told that I was type 2, we came up with an even healthier diet and added exercise that we hoped would help control the disease.
My wife followed up per the doctor's suggestion and first called the nutritionist. After she told the nutritionist everything that was going on, the nutritionist suggested that I might have been misdiagnosed and that maybe I really had type 1 diabetes. She advised me to consult with an endocrinologist as soon as possible, but the endocrinologist could not fit me in until a week later. In the meantime, my wife and I met with the nutritionist and a certified diabetes educator (CDE). We arrived with our diabetic binder that contained all of our research, including lab results, print/web articles, and my detailed diet plan. The nutritionist was very impressed that we had come up with such an aggressive and structured plan so quickly. She did tell us, however, that she still believed that I had type 1, not type 2, and that we should keep that in mind.
My initial consultation with the endocrinologist was really nothing much. He evaluated the initial lab results, my diet plan, and the medications I was taking, and he ordered more tests to see what was really going on. A follow-up meeting with the endocrinologist was set for two weeks later, and I went in for additional blood work in the interim. As the days went by, my numbers did start to improve, but my health deteriorated more and more. The final two days before the endocrinologist appointment, I was not able to keep any food down and I felt horrible.
At the follow-up visit with my endocrinologist, he confirmed that I had type 1 diabetes. That explained why I felt so horrible. I was immediately prescribed insulin and sent on my way. Like all newly diagnosed people with type 1, I took a few weeks to get the dosages and numbers to the point where I needed them. After that, I began looking for a new challenge.
Back in the 1980s, I used to surf both as an amateur and as a professional. Throughout the intervening years, however, my life changed, and so did my priorities. Because I didn't make a bundle of money surfing, I had to settle down and get a real job. Along the way I also got married and had two wonderful sons, ages 18 and eight. Now that I had this new disease, however, I decided that working toward competing again would be an excellent form of exercise to help my diabetes. With that, I started surfing again, four to five times a week.
Exercising presented me with a couple of new challenges. I found that every time I surfed, my blood glucose (BG) level dropped very quickly. I would go from 120 to the low 60s in a matter of 60 minutes. Consequently, I learned to go into the water a little higher. I also always have a surfing buddy, just to make sure that I have support should anything go wrong or should I ever go too low. Passing out in the water is a whole lot more dangerous than passing out on dry land.
It wasn't long before I, like most competitive people, got the itch to step up my surfing game and get back into competition. Things were going really well for me at this point. I had all the support in the world from my family and sponsors. My numbers were getting better, and I was getting good results in surfing contests. Still, I wanted better BG numbers and as low an A1c as possible. For that reason, my wife and I started researching insulin pumps just three months after my diagnosis. We ended up going with Medtronic's Minimed insulin pump, and we began working toward getting the continuous glucose monitor (CGM) that works with the pump.
A couple of reasons were behind our decision. For one, another surfer was already using a Medtronic, and he loved it. For another, the company was working on a waterproof housing so that the device could be worn in the water. Last but not least, I would not have to carry a second device if I used Medtronic's CGM to monitor my BG levels 24/7. The Minimed not only delivers insulin, but also works wirelessly to collect and store all the BG levels from the CGM. Because I am an information technology manager by trade, I always like having as much data as possible.
I was approved immediately for the Medtronic Minimed insulin pump, and within 30 days I had my CGM as well. (Anthem BlueCross is my primary healthcare insurer and United Healthcare is my secondary.)
As with all new devices, a learning curve is involved. However, with help from the rep, the endocrinologist, and my very smart and supportive wife, we got everything dialed in within a week or two. After 90 days on the pump and using the CGM for additional information, I was able to get my A1c down from 14% to an amazing 6.3%. Today (about one year out) I have an A1c of 5.7%, but I remain committed to keeping my numbers low by testing six to eight times a day, eating right, and exercising often.
I am continuing to have great success surfing, thanks to sponsorship support from Medtronic, Bessell Surf, Fast Blue Communications, JETPILOT Clothing & Wetsuits, Freestyle Watches, Spy Optics, H2O Audio, Globe Shoes, Kicker Audio, Bubble Gum Surf Wax, Drop In Ride Shop, and BioNutritional Research Group. I am even going to do a few pro events this year.
One of my requirements of my surfing sponsors is that they must be willing to give me stickers, clothes, and other gadgets. When my wife and I visit the diabetic wards in hospitals, we hand out all the goodies to the kids. There is nothing more rewarding then giving a child some free stuff and seeing that smile on her face when she realizes that somebody out there cares and is successfully living with the same disease.
When people find out that I have diabetes, I often hear them say, "Sorry to hear about your disease," or "Oh man, that is a slow death sentence." However, I look at it from the opposite perspective. I am happy to share my story and educate people that having diabetes doesn't make me different from anybody else, except that I probably eat better and live healthier then most people!
Because I was always an athlete, I used to take my health for granted. I rarely went to the doctor, and I pretty much ate and drank what I wanted. Diabetes actually came into my life at just the right time (in my late thirties) to help me start eating healthier and get on a regular exercise program. But the number one thing that has helped me keep my disease under control has been the love and support of my wonderful wife and family. It's a team effort. With support, anything is possible!
Very Inspiring.....
LIVE GOOD,
deb
GOOD NEWS KEEPS ROLLING IN!
Good News Keeps Rolling In!
It’s been an amazing start to the New Year for JDRF Advocacy! The good news keeps rolling in and it all started with you helping us get to 200 meetings with Members of Congress. By the way, we’re at 221 meetings as of today.
If you’ve been tracking JDRF Advocacy’s for the past week or so, you would have noticed that JDRF is working with Animas to bring the first generation of the artificial pancreas to the market in the next three years. Yesterday, we announced that we’re also collaborating with BD’s (Becton, Dickinson and Company) research and development folks to improve the management of type 1 diabetes by developing novel insulin delivery products to enhance the use of insulin pumps. This means improving convenience as well as minimizing pain!
The research that has allowed us to continue our journey towards a cure is in part due to fundraising of JDRF volunteers and in part due to personal stories shared by volunteers with their legislators. It is through your personal stories that Members of Congress come to understand the toll of diabetes on our loved ones and our families. Thus, making programs like the Promise to Remember Campaign a vital part of having our stories heard and ensuring that the Federal government continues to provide research funds for type 1 diabetes. If it wasn’t for the persistent efforts of volunteers and advocates, JDRF and the Federal government would have limited resources to continue to look for a cure.
Please help make sure that the private-public partnership of JDRF and the government continues to yield successes for our loved ones, join the Promise Campaign to attend a meeting or lead one of your own. Send an email to sshah@jdrf.org if you’re interested in leading a Promise meeting.
LIVE GOOD,
deb
It’s been an amazing start to the New Year for JDRF Advocacy! The good news keeps rolling in and it all started with you helping us get to 200 meetings with Members of Congress. By the way, we’re at 221 meetings as of today.
If you’ve been tracking JDRF Advocacy’s for the past week or so, you would have noticed that JDRF is working with Animas to bring the first generation of the artificial pancreas to the market in the next three years. Yesterday, we announced that we’re also collaborating with BD’s (Becton, Dickinson and Company) research and development folks to improve the management of type 1 diabetes by developing novel insulin delivery products to enhance the use of insulin pumps. This means improving convenience as well as minimizing pain!
The research that has allowed us to continue our journey towards a cure is in part due to fundraising of JDRF volunteers and in part due to personal stories shared by volunteers with their legislators. It is through your personal stories that Members of Congress come to understand the toll of diabetes on our loved ones and our families. Thus, making programs like the Promise to Remember Campaign a vital part of having our stories heard and ensuring that the Federal government continues to provide research funds for type 1 diabetes. If it wasn’t for the persistent efforts of volunteers and advocates, JDRF and the Federal government would have limited resources to continue to look for a cure.
Please help make sure that the private-public partnership of JDRF and the government continues to yield successes for our loved ones, join the Promise Campaign to attend a meeting or lead one of your own. Send an email to sshah@jdrf.org if you’re interested in leading a Promise meeting.
LIVE GOOD,
deb
INSULIN SITE LOCATION
Insulin Injection Site Rotation - 5 Tips for Insulin Injection Site Rotation
The Best Way to Inject Insulin
By Gary Gilles, About.com Guide
Multiple insulin injections each day are a way of life for those with type 1 diabetes. But did you know that where you inject the insulin makes a big difference in the absorption level and effectiveness of the insulin?
Here are 5 tips that will help ensure that your injections are working hard for you.
1. Give injections in the abdomen, thighs and back of the upper arm whenever possible.
Insulin is most rapidly absorbed when injected in the abdomen, followed by the upper arm and thigh area. Injections in your hip and buttock areas are more slowly absorbed. Never inject within two inches of your navel.
2. Choose a slightly new location for each injection.
This is called site rotation. For example, if you give all of your injections in the abdomen, note of where your last injection was given and move the next one about an inch to one side or the other. Continue to move the injection site until you’ve covered all the available sites before starting a new area.
3. Always inject insulin into fatty tissue instead of muscle.
That’s why the abdomen, upper back of the arms and outer thigh are preferred. These areas are easy to reach and have ample amounts of have fatty tissue (called subcutaneous fat). These areas also reduce the risk of injecting insulin too close to a large blood vessel or nerve.
4. Give your injections in the same general area at the same time each day.
For example, take your morning insulin in your abdomen and your afternoon or evening insulin in your arm. This consistency helps your body better absorb the insulin over random injections.
5. Keep accurate records of your site rotation.
This will help you avoid injecting the same area repeatedly. Doing so is likely to result in the development fat deposits that can make your skin look lumpy and delay the absorption of insulin.
LVE GOOD,
deb
The Best Way to Inject Insulin
By Gary Gilles, About.com Guide
Multiple insulin injections each day are a way of life for those with type 1 diabetes. But did you know that where you inject the insulin makes a big difference in the absorption level and effectiveness of the insulin?
Here are 5 tips that will help ensure that your injections are working hard for you.
1. Give injections in the abdomen, thighs and back of the upper arm whenever possible.
Insulin is most rapidly absorbed when injected in the abdomen, followed by the upper arm and thigh area. Injections in your hip and buttock areas are more slowly absorbed. Never inject within two inches of your navel.
2. Choose a slightly new location for each injection.
This is called site rotation. For example, if you give all of your injections in the abdomen, note of where your last injection was given and move the next one about an inch to one side or the other. Continue to move the injection site until you’ve covered all the available sites before starting a new area.
3. Always inject insulin into fatty tissue instead of muscle.
That’s why the abdomen, upper back of the arms and outer thigh are preferred. These areas are easy to reach and have ample amounts of have fatty tissue (called subcutaneous fat). These areas also reduce the risk of injecting insulin too close to a large blood vessel or nerve.
4. Give your injections in the same general area at the same time each day.
For example, take your morning insulin in your abdomen and your afternoon or evening insulin in your arm. This consistency helps your body better absorb the insulin over random injections.
5. Keep accurate records of your site rotation.
This will help you avoid injecting the same area repeatedly. Doing so is likely to result in the development fat deposits that can make your skin look lumpy and delay the absorption of insulin.
LVE GOOD,
deb
Tuesday, January 26, 2010
joining forces.....jan.20, 2010
Fast Forward, Juvenile Diabetes Research Foundation And Axxam SpA Join Forces To Develop Treatments For Multiple Sclerosis And Type 1 Diabetes
Article Date: 20 Jan 2010 - 2:00 PST
Fast Forward, LLC, the commercial drug development arm of the National Multiple Sclerosis Society, and the Juvenile Diabetes Research Foundation (JDRF), the leader in research leading to a cure for type 1 diabetes in the world announced a collaborative partnership with Axxam SpA -- a leading company in conducting early-stage discovery research programs for the life science industry -- to develop new treatments for two autoimmune diseases, multiple sclerosis (MS) and type 1 diabetes (T1D).
Under the terms of the agreement, Axxam will screen its extensive chemical library to identify compounds that can target specific ion channels in the immune system. Ion channels are tiny pores on the surface of immune cells that control the influx of charged particles and allow the cells to become activated to perform their natural surveillance and protection functions. Recent studies have found that immune cells in MS and T1D contain high levels of a specific ion channel, Kv1.3, and that the hyperactivity of this channel contributes to the dysfunction of the immune system in MS and T1D. If the initial research is successful, Axxam will have identified compounds that modulate Kv1.3 ion channel activities, and these will be further developed by the company as potential therapies for MS and T1D.
The agreement with Axxam is the first of its kind between cross-disciplinary patient advocacy organizations and represents a new frontier in which groups such as JDRF and Fast Forward ally to lessen the risk of drug discovery and accelerate the development of new therapies that can impact multi-disorders. "We are pleased to partner with Axxam and JDRF to advance the development of new treatments for T1D and MS," said Dr. Timothy Coetzee, President of Fast Forward. Adds Dr. Coetzee, "People with MS and T1D need more treatment options and the approach taken by Axxam holds great promise for both diseases."
"Our partnership with Fast Forward and Axxam opens exciting new avenues for JDRF to speed the translation of basic research into drugs and treatments for type 1 diabetes," said Alan J. Lewis, PhD, President and Chief Executive Officer of JDRF. "Research into the Kv1.3 ion channel has the potential to negate the autoimmune process causing type 1 diabetes and multiple sclerosis, which must be addressed to cure these diseases."
"It's rewarding for Axxam to be working with two world class non-profits dedicated to speeding new therapies to their constituencies," said Dr. Stefan Lohmer, Ph.D., Chairman and Chief Executive Officer of Axxam. "This collaboration recognizes the quality of our research in the challenging ion channels field and we hope to be on the cusp for developing potential new therapies for both type 1 diabetes and multiple sclerosis."
About JDRF:
JDRF is the worldwide leader for research to cure type 1 diabetes. 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.
Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.4 billion to diabetes research, including $101 million in FY2009. In FY2009, JDRF funded research projects in 22 countries throughout the world, including more than 40 human clinical trials.
About Fast Forward, LLC
About Axxam SpA
Axxam is a discovery company focused on research programs for different applications in the life science industry. They are a privately owned biotech firm based at the San Raffaele Biomedical Science Park in Milan (Italy), with a team of about 60 highly skilled qualified people. Axxam began operations as an independent and privately owned company in November 2001, but its roots are built upon years of experience as part of the Bayer HealthCare, Research and Development organization. The company performs a wide range of activities including assay development, high-throughput screening, compound profiling and hits to leads testing. In addition, Axxam conducts several discovery programs for selected targets which are carried out in partnership with other companies or non-profit organizations.Fast Forward, Juvenile Diabetes Research Foundation And Axxam SpA Join Forces To Develop Treatments For Multiple Sclerosis And Type 1 Diabetes
Article Date: 20 Jan 2010 - 2:00 PST
Fast Forward, LLC, the commercial drug development arm of the National Multiple Sclerosis Society, and the Juvenile Diabetes Research Foundation (JDRF), the leader in research leading to a cure for type 1 diabetes in the world announced a collaborative partnership with Axxam SpA -- a leading company in conducting early-stage discovery research programs for the life science industry -- to develop new treatments for two autoimmune diseases, multiple sclerosis (MS) and type 1 diabetes (T1D).
Under the terms of the agreement, Axxam will screen its extensive chemical library to identify compounds that can target specific ion channels in the immune system. Ion channels are tiny pores on the surface of immune cells that control the influx of charged particles and allow the cells to become activated to perform their natural surveillance and protection functions. Recent studies have found that immune cells in MS and T1D contain high levels of a specific ion channel, Kv1.3, and that the hyperactivity of this channel contributes to the dysfunction of the immune system in MS and T1D. If the initial research is successful, Axxam will have identified compounds that modulate Kv1.3 ion channel activities, and these will be further developed by the company as potential therapies for MS and T1D.
The agreement with Axxam is the first of its kind between cross-disciplinary patient advocacy organizations and represents a new frontier in which groups such as JDRF and Fast Forward ally to lessen the risk of drug discovery and accelerate the development of new therapies that can impact multi-disorders. "We are pleased to partner with Axxam and JDRF to advance the development of new treatments for T1D and MS," said Dr. Timothy Coetzee, President of Fast Forward. Adds Dr. Coetzee, "People with MS and T1D need more treatment options and the approach taken by Axxam holds great promise for both diseases."
"Our partnership with Fast Forward and Axxam opens exciting new avenues for JDRF to speed the translation of basic research into drugs and treatments for type 1 diabetes," said Alan J. Lewis, PhD, President and Chief Executive Officer of JDRF. "Research into the Kv1.3 ion channel has the potential to negate the autoimmune process causing type 1 diabetes and multiple sclerosis, which must be addressed to cure these diseases."
"It's rewarding for Axxam to be working with two world class non-profits dedicated to speeding new therapies to their constituencies," said Dr. Stefan Lohmer, Ph.D., Chairman and Chief Executive Officer of Axxam. "This collaboration recognizes the quality of our research in the challenging ion channels field and we hope to be on the cusp for developing potential new therapies for both type 1 diabetes and multiple sclerosis."
About JDRF:
JDRF is the worldwide leader for research to cure type 1 diabetes. 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.
Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.4 billion to diabetes research, including $101 million in FY2009. In FY2009, JDRF funded research projects in 22 countries throughout the world, including more than 40 human clinical trials.
About Fast Forward, LLC
About Axxam SpA
Axxam is a discovery company focused on research programs for different applications in the life science industry. They are a privately owned biotech firm based at the San Raffaele Biomedical Science Park in Milan (Italy), with a team of about 60 highly skilled qualified people. Axxam began operations as an independent and privately owned company in November 2001, but its roots are built upon years of experience as part of the Bayer HealthCare, Research and Development organization. The company performs a wide range of activities including assay development, high-throughput screening, compound profiling and hits to leads testing. In addition, Axxam conducts several discovery programs for selected targets which are carried out in partnership with other companies or non-profit organizations.Fast Forward, Juvenile Diabetes Research Foundation And Axxam SpA Join Forces To Develop Treatments For Multiple Sclerosis And Type 1 Diabetes
Saturday, January 23, 2010
pause and reflect....be thankful
Welcome to myblog. Every person should definitely have one of their own, whether literally or figuratively. It's a place where I take a moment to pause and reflect, and give thanks for the gift of life.
Friday, January 22, 2010
regeneration.....
Among the fastest-growing scientific areas JDRF supports is research aimed at regenerating insulin producing cells in people who have diabetes (as opposed to transplanting cells from organ donors or other sources). This involves triggering the body to grow its own new insulin producing cells, either by copying existing ones - some are usually still active, even in people who have had diabetes for decades - or causing the pancreas to create new ones.
Regeneration: Recent Key Advances, Spring 2009
Two-Drug Combination Therapy Reverses Type 1 Diabetes
In a study in mice, scientists found that a short treatment with two drugs reversed type 1 diabetes. The combination therapy - glucagon-like peptide-1 (GLP-1) and gastrin - increased the number of beta cells in the mice. Scientists were surprised to find evidence that the therapy also seemed to tamp down the autoimmune attack. The findings suggest that the two drugs work together to target both the cellular mechanisms that promote beta cell growth and survival, as well as the immunologic mechanisms that destroy beta cells in type 1 diabetes. The work, which was carried out by Dr. Alex Rabinovitch at the University of Alberta and Dr. Mark Atkinson at the University of Florida, was funded by grants from JDRF and Transition Therapeutics, one of JDRF's Industry Discovery and Development partners.
What this may mean for people with type 1 diabetes: The findings provide encouraging evidence that this therapy might be effective in both increasing beta cell mass and slowing the autoimmune process - which would make it an extremely attractive avenue for treating people with type 1 diabetes. However, these results must be validated in human clinical trials. JDRF has partnered with Transition Therapeutics to develop a clinical trial, and Transition Therapeutics recently announced a partnership with the pharmaceutical company Eli Lilly, which is expected to further speed its development.
Compounds That Trigger Beta Cell Replication Are Identified
Researchers at the Genomics Institute of the Novartis Research Foundation (GNF) have identified a set of compounds that can trigger the proliferation of insulin-producing cells in the pancreas. Using a sophisticated technique called high-throughput screening, a research team led by Dr. Peter Schultz, Institute Director at GNF, screened a large chemical "library" of over 850,000 compounds for their effect on the growth of a mouse beta cell line. Out of this large collection, about 80 compounds showed promise for further investigation, and two were particularly noteworthy. One of the two appears to promote beta cell replication via a biological pathway critical for beta cell development in the embryo.
What this may mean for people with type 1 diabetes: The study, funded by JDRF, is the first of its kind in type 1 diabetes and represents an important initial step in the possible discovery of regenerative medicines for type 1 patients. "Targeting beta cell regeneration is still a relatively new approach for the treatment of type 1 diabetes," said Patricia Kilian, Director of Regeneration Research at JDRF. "This study is a step toward identifying small molecules that may induce the expansion of beta cells, and it may help reveal the biological mechanisms regulating this process."
live good,
deb
Regeneration: Recent Key Advances, Spring 2009
Two-Drug Combination Therapy Reverses Type 1 Diabetes
In a study in mice, scientists found that a short treatment with two drugs reversed type 1 diabetes. The combination therapy - glucagon-like peptide-1 (GLP-1) and gastrin - increased the number of beta cells in the mice. Scientists were surprised to find evidence that the therapy also seemed to tamp down the autoimmune attack. The findings suggest that the two drugs work together to target both the cellular mechanisms that promote beta cell growth and survival, as well as the immunologic mechanisms that destroy beta cells in type 1 diabetes. The work, which was carried out by Dr. Alex Rabinovitch at the University of Alberta and Dr. Mark Atkinson at the University of Florida, was funded by grants from JDRF and Transition Therapeutics, one of JDRF's Industry Discovery and Development partners.
What this may mean for people with type 1 diabetes: The findings provide encouraging evidence that this therapy might be effective in both increasing beta cell mass and slowing the autoimmune process - which would make it an extremely attractive avenue for treating people with type 1 diabetes. However, these results must be validated in human clinical trials. JDRF has partnered with Transition Therapeutics to develop a clinical trial, and Transition Therapeutics recently announced a partnership with the pharmaceutical company Eli Lilly, which is expected to further speed its development.
Compounds That Trigger Beta Cell Replication Are Identified
Researchers at the Genomics Institute of the Novartis Research Foundation (GNF) have identified a set of compounds that can trigger the proliferation of insulin-producing cells in the pancreas. Using a sophisticated technique called high-throughput screening, a research team led by Dr. Peter Schultz, Institute Director at GNF, screened a large chemical "library" of over 850,000 compounds for their effect on the growth of a mouse beta cell line. Out of this large collection, about 80 compounds showed promise for further investigation, and two were particularly noteworthy. One of the two appears to promote beta cell replication via a biological pathway critical for beta cell development in the embryo.
What this may mean for people with type 1 diabetes: The study, funded by JDRF, is the first of its kind in type 1 diabetes and represents an important initial step in the possible discovery of regenerative medicines for type 1 patients. "Targeting beta cell regeneration is still a relatively new approach for the treatment of type 1 diabetes," said Patricia Kilian, Director of Regeneration Research at JDRF. "This study is a step toward identifying small molecules that may induce the expansion of beta cells, and it may help reveal the biological mechanisms regulating this process."
live good,
deb
breaking news..honeymoon phase..
ITN’s START study of Newly Diagnosed Type 1 Diabetes begins Pediatric Enrollment
January 20, 2010 -- The ITN's START research trial for new-onset type 1 diabetes has received the approval of its Data Safety and Monitoring Board to accept patients aged 12-18 years into the study. The decision was made after a review of safety data from the initial group of 10 adult subjects enrolled into the study. The trial is now open to individuals between the ages of 12-35 who have been diagnosed with new-onset type 1 diabetes within the past 3 months. The START trial is being conducted under the direction of principal investigator Dr. Stephen Gitelman at the University of California, San Francisco and at 9 other research centers in the U.S.
Type 1 diabetes is an autoimmune disease caused by an errant immune system attack on the insulin-producing beta cells located in the pancreas. The goal of the START trial is to determine whether the drug Thymoglobulin can delay or permanently halt this attack after only a short period of treatment with the drug. Thymoglobulin is a mixture of antibodies that targets T cells, the subset of immune system cells implicated in the destruction of beta cells. Although considered an experimental treatment for type 1 diabetes, Thymoglobulin is already in use worldwide and has received FDA approval for the treatment of organ transplant rejection. It is also used for treatment of other autoimmune conditions, including aplastic anemia.
Researchers are hopeful that this combination will offer an improvement upon existing treatment regimens, although they are careful to point out that it is still an experimental treatment. "We're extremely excited to see this trial open to pediatric enrollment," said principal investigator of the trial, Dr. Gitelman. "Clinical trials like the START trial are very important because people need expanded treatment options for newly diagnosed type I diabetes ."
The START trial, short for "Study of Thymoglobulin to Arrest Type 1 diabetes", aims to enroll a total of 66 subjects at 10 clinical centers across the US. It is a project of the Immune Tolerance Network and is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Juvenile Diabetes Research Foundation.
More information about the START trial is available at www.type1diabetestrial.org
The START study is being conducted at the following research institutions:
San Francisco - The Diabetes Center at UCSF
Oakland - Children's Hospital
San Diego - UCSD/San Diego Children's Hospital
Los Angeles - Children's Hospital/USC School of Medicine
Denver - Barbara Davis Center for Childhood Diabetes
Kansas City - Children's Mercy Hospital
Minneapolis - University of Minnesota
Philadelphia - University of Pennsylvania/Children's Hospital of Philadelphia
Atlanta - Emory University
Connecticut - Yale University
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January 20, 2010 -- The ITN's START research trial for new-onset type 1 diabetes has received the approval of its Data Safety and Monitoring Board to accept patients aged 12-18 years into the study. The decision was made after a review of safety data from the initial group of 10 adult subjects enrolled into the study. The trial is now open to individuals between the ages of 12-35 who have been diagnosed with new-onset type 1 diabetes within the past 3 months. The START trial is being conducted under the direction of principal investigator Dr. Stephen Gitelman at the University of California, San Francisco and at 9 other research centers in the U.S.
Type 1 diabetes is an autoimmune disease caused by an errant immune system attack on the insulin-producing beta cells located in the pancreas. The goal of the START trial is to determine whether the drug Thymoglobulin can delay or permanently halt this attack after only a short period of treatment with the drug. Thymoglobulin is a mixture of antibodies that targets T cells, the subset of immune system cells implicated in the destruction of beta cells. Although considered an experimental treatment for type 1 diabetes, Thymoglobulin is already in use worldwide and has received FDA approval for the treatment of organ transplant rejection. It is also used for treatment of other autoimmune conditions, including aplastic anemia.
Researchers are hopeful that this combination will offer an improvement upon existing treatment regimens, although they are careful to point out that it is still an experimental treatment. "We're extremely excited to see this trial open to pediatric enrollment," said principal investigator of the trial, Dr. Gitelman. "Clinical trials like the START trial are very important because people need expanded treatment options for newly diagnosed type I diabetes ."
The START trial, short for "Study of Thymoglobulin to Arrest Type 1 diabetes", aims to enroll a total of 66 subjects at 10 clinical centers across the US. It is a project of the Immune Tolerance Network and is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Juvenile Diabetes Research Foundation.
More information about the START trial is available at www.type1diabetestrial.org
The START study is being conducted at the following research institutions:
San Francisco - The Diabetes Center at UCSF
Oakland - Children's Hospital
San Diego - UCSD/San Diego Children's Hospital
Los Angeles - Children's Hospital/USC School of Medicine
Denver - Barbara Davis Center for Childhood Diabetes
Kansas City - Children's Mercy Hospital
Minneapolis - University of Minnesota
Philadelphia - University of Pennsylvania/Children's Hospital of Philadelphia
Atlanta - Emory University
Connecticut - Yale University
print versionhome research professionals' site contacts sitemap search
© Immune Tolerance Network.
Privacy
Terms of Use
Accessibility
Web Design by IMAGEX MEDIA
researchers are wonderful....
Researchers Discover Potential Diabetes Cure
By Elyssa A. L. Spitzer, CONTRIBUTING WRITER
Published: Friday, October 24, 2008
As a college student in Australia, Maria Koulmanda began researching type 1 diabetes as part of a summer job. Thirty years later, Koulmanda and her colleagues at Harvard Medical School now think that they may have found a cure.
In a study on mice, the researchers found that a protein used to treat people with emphysema and lung diseases may also promote insulin production in diabetics.
If the protein is as effective in humans as it was in mice, a few months of treatment would permit type 1 diabetics to produce their own insulin, rather than injecting themselves with synthetic insulin with each meal.
The breakthrough “would help 24.5 million people who do have type 1 diabetes,” said Shana Vernoia of the Juvenile Diabetes Research Foundation.
While injecting insulin allows a diabetic to manage his or her illness, the only way to cure diabetes is a pancreas transplant, which requires taking intensive immunosuppressant drugs so that the person’s body does not reject the organ.
The protein cure would be the first of its kind, and could be particularly useful in treating children, who cannot receive transplants because of the severity of the immunosupressant drugs that are required.
In type 1 diabetes, a person’s t-cells destroy insulin-producing cells in his or her pancreas, mistaking them for foreign cells.
Without insulin, which removes glucose from the bloodstream, the body’s organs can be damaged and cells are unable to metabolize glucose, meaning that no energy is produced to fuel the person’s body.
Before insulin was discovered in the 1920s, “diabetic children would die,” said Koulmanda, who is an assistant professor of surgery at the Medical School.
With the new treatment, Kolumanda said, the protein suppresses the cells that would inhibit the production of insulin and increases the production of those that enchance it. This, she said, creates “a very friendly environment where the beta cells are not attacked anymore and where the [insulin-producing] cells can recover and multiply.”
Koulmanda said she and her co-author, Terry B. Strom, a Medical School professor, hope to begin clinical trials by the end of the year.
Their work has been conditionally approved by the Immune Tolerance Network, which examines research protocols and determines whether it will support research for clinical trials, according to Koulmanda.
Koulmanda said that though she doesn’t have any personal experience with diabetes, she empathizes with the millions of people that her work could help.
“Fortunately, I don’t have anyone who is a diabetic in my family,” Koulmanda said. “[But] going to clinic is very personal, with 30 years of my life working on it.”
By Elyssa A. L. Spitzer, CONTRIBUTING WRITER
Published: Friday, October 24, 2008
As a college student in Australia, Maria Koulmanda began researching type 1 diabetes as part of a summer job. Thirty years later, Koulmanda and her colleagues at Harvard Medical School now think that they may have found a cure.
In a study on mice, the researchers found that a protein used to treat people with emphysema and lung diseases may also promote insulin production in diabetics.
If the protein is as effective in humans as it was in mice, a few months of treatment would permit type 1 diabetics to produce their own insulin, rather than injecting themselves with synthetic insulin with each meal.
The breakthrough “would help 24.5 million people who do have type 1 diabetes,” said Shana Vernoia of the Juvenile Diabetes Research Foundation.
While injecting insulin allows a diabetic to manage his or her illness, the only way to cure diabetes is a pancreas transplant, which requires taking intensive immunosuppressant drugs so that the person’s body does not reject the organ.
The protein cure would be the first of its kind, and could be particularly useful in treating children, who cannot receive transplants because of the severity of the immunosupressant drugs that are required.
In type 1 diabetes, a person’s t-cells destroy insulin-producing cells in his or her pancreas, mistaking them for foreign cells.
Without insulin, which removes glucose from the bloodstream, the body’s organs can be damaged and cells are unable to metabolize glucose, meaning that no energy is produced to fuel the person’s body.
Before insulin was discovered in the 1920s, “diabetic children would die,” said Koulmanda, who is an assistant professor of surgery at the Medical School.
With the new treatment, Kolumanda said, the protein suppresses the cells that would inhibit the production of insulin and increases the production of those that enchance it. This, she said, creates “a very friendly environment where the beta cells are not attacked anymore and where the [insulin-producing] cells can recover and multiply.”
Koulmanda said she and her co-author, Terry B. Strom, a Medical School professor, hope to begin clinical trials by the end of the year.
Their work has been conditionally approved by the Immune Tolerance Network, which examines research protocols and determines whether it will support research for clinical trials, according to Koulmanda.
Koulmanda said that though she doesn’t have any personal experience with diabetes, she empathizes with the millions of people that her work could help.
“Fortunately, I don’t have anyone who is a diabetic in my family,” Koulmanda said. “[But] going to clinic is very personal, with 30 years of my life working on it.”
Thursday, January 21, 2010
found this interesting article...
Type 1 Diabetes Cure
Diabetes News: Finding the Causes of Diabetes, Medicinal Herbs Used in China Are Shown to Lower Glucose Levels. Please also read Yu Xiao San 8805 on Type I and Type II Diabetes and Hypoglycemic Effects of Selected Ingredients
In response to the growing health burden of diabetes mellitus (diabetes), the diabetes community has three choices: prevent diabetes; cure diabetes; and take better care of people with diabetes to prevent devastating complications. All three approaches are actively being pursued by the US Department of Health and Human Services.
Both the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) are involved in prevention activities. The NIH is involved in research to cure both type 1 and type 2 diabetes, especially type 1. CDC focuses most of its programs on being sure that the proven science is put into daily practice for people with diabetes. The basic idea is that if all the important research and science are not made meaningful in the daily lives of people with diabetes, then the research is, in essence, wasted.
Several approaches to "cure" diabetes are being pursued:
Pancreas transplantation
Islet cell transplantation (islet cells produce insulin)
Artificial pancreas development
Genetic manipulation (fat or muscle cells that don?t normally make insulin have a human insulin gene inserted ? then these "pseudo" islet cells are transplanted into people with type 1 diabetes).
Each of these approaches still has a lot of challenges, such as preventing immune rejection; finding an adequate number of insulin cells; keeping cells alive; and others. But progress is being made in all areas.
(From the National Institute of Health)
Diabetes Type 1: One Step Closer To A Cure - Interview
Patrick Perry, Saturday Evening Post
Will successful islet cell transplantation spell the end of Type 1 diabetes for millions?
To some, it is nothing short of a miracle.
"I remember thinking, If someone could give me a present, I would ask for just one day that I wasn't diabetic," said junior-high-school teacher Mary Anna Kralj-Pokerznik, 30. "Now I've had 13 months. It's like being released from a prison you've been in for years and years."
The teacher was one of seven patients who received a revolutionary treatment for Type 1 diabetes, an autoimmune disease in which the body destroys the insulin-producing beta cells in the pancreas.
News of the successful islet cell-transplant procedure for Type 1 diabetes spread to every news program and newspaper in the world. And diabetes researchers tout the treatment as a major step forward in treating the disease; some even hail it as a "cure."
Certainly, the islet cell-transplant procedure, known as the Edmonton protocol, ushers in an era of renewed hope for the more than one million people with Type 1 diabetes. Patients with the disorder must constantly monitor their blood sugars and endure multiple insulin injections daily just to survive.
The islet cell transplant procedure was pioneered in clinical trials at the University of Alberta, and the antirejection protocol was designed by James Shapiro, M.D., director of the clinical islet transplant program.
The novel protocol departs from previous attempts at islet cell transplant in that it uses a novel steroid-free combination of three drugs to prevent rejection of the transplanted cells, a procedure that appears to prevent the autoimmune diabetes from returning.
Like many great medical discoveries, the new approach came to Dr. Shapiro as a hunch. While sitting in a hotel room on a rainy day in Baltimore, he sat down and wrote the protocol. He had been asked to return to the University of Alberta after a hiatus at the University of Maryland--and needed to come up with a new method of forcing the human body to produce its own insulin.
"I told myself I was going to give it one last try," said Shapiro, who with many other researchers from around the world had tried repeatedly to transplant islets to severe insulin-dependent patients with little success.
Using the steroid-free protocol, seven of seven patients in the trial--some of whom were administering up to 15 injections a day--are now insulin-independent, free of daily insulin injections and constant worry. The results of the trial were published in the New England Journal of Medicine.
"My life has totally changed," said Robert Teskey, a Type 1 diabetic who was part of the landmark trial. "Gone is the need to think about how much insulin to take at every meal. Gone is the need to test my blood endlessly. Gone is the need to mentally calculate the nutritional, and particularly the complex-carbohydrate and simple-sugar, content of every meal or snack. Most of all, gone is the fear of an incapacitating insulin reaction."
The research team, led by a 28-year veteran of islet cell transplant, Ray Rajotte, Ph.D., will now teach the Edmonton Protocol to centers around the world. Clinical trials in the United States and Europe will begin shortly.
To learn more about the breakthrough, we spoke with Jonathan Lakey, Ph.D., director of the Human Islet Isolation Laboratory at the University of Alberta and coauthor of the NEJM study, about the innovative transplant procedure.
Q: Could you tell us about the successful clinical study of islet transplantation for Type 1 diabetics?
A: The results showed that islet transplantation can reverse the hyperglycemia experienced in Type 1 diabetes and that islet transplantation is now a viable option for the treatment of diabetes. In the clinical trial reported in the NEJM, we had a series of seven patients who received islet cells isolated from donor pancreases. The cells were transplanted into these patients through the hepatic portal vein. The transplanted islets flowed through the vein up to the liver, where they were engrafted and are now secreting insulin. Basically, all patients are totally off insulin. Their hemoglobin A1C, which is a marker for glucose function, is normal and has remained normal for all follow-up visits. The longest patient has been insulin-free about 15 months; the average is about 12 months.
Q: Were you surprised by the results of the trial?
A: We were very surprised. But it is what we hoped we would see. When we did the first transplant about 15 months ago, we were ecstatic. The second transplant helped confirm what we were seeing in the first patient, as did the third, fourth, and fifth. It developed faster than we had hoped.
Q: Why the portal vein in the liver, since islet cells normally would reside in the pancreas?
A: The liver still provides portal blood drainage, meaning that the islets--if in the pancreas and still functioning--would be secreting insulin, and the insulin would be going through the portal system up through the liver. So you still get portal vein drainage. The reason that we didn't transplant into the pancreas is that putting a needle into the portal vein is much simpler than trying to go into the pancreas.
Q: How are these islet cells able to take residence in the liver and reproduce?
A: Basically, the liver is like a big filter, so the transplanted cells flow into the liver and get clogged, in the small bed of the liver. Once there, they start secreting insulin from that point on and develop a whole new blood supply as well. There has been some work in animal models showing this. It is really quite amazing.
Q: Previous attempts at islet cell transplantation have been somewhat disappointing. What did your research team do differently in this trial?
A: In the laboratory--and this is my area--we have been able to develop techniques to improve the recovery of both the number of islets and the functional viability of human islets. We changed the traditional method of isolating islets and developed newer techniques that deliver more viable cells for transplant. We accomplished that in a number of different ways. First, we worked with industry to develop a product, an enzyme blend called Liberase, that is used to help digest the donor pancreas into its tissue components. We have also developed a method to load that enzyme into the pancreas, using a regulated perfusion system that controls the flow of the temperature and the pressure. We feel that this method allows maximal delivery of the enzyme into the pancreas.
The second step was the dissociation. Using enzymes and mechanical methods, we break the pancreas apart, then separate the islets from the exocrine tissue based on differences in their density. That method has worked very well and consistently. We have also eliminated animal products. Typically, fetal calf serum is added during various steps of the islet isolation process to inactivate enzymes, as well as to provide nutrients.
Q: Does eliminating animal products reduce the possibility of rejection?
A: We think that it might. In the past, the islets have all been isolated with fetal calf serum. This fetal calf serum could be coding the islets and act like a big red flag to the body to destroy these cells when injected. We hope that by not using animal serum, we will not elicit such an active immune response.
Q: What immunosuppressants did you use?
A: Typically, all islet transplants in the past have used steroids. We eliminated steroids from our transplant protocol. We are using two new drugs; one is called Rapimmune, made by Wyeth-Ayerst, and the other is Tacrolimus, or FK506. Tacrolimus has been around for a while, but we are using it at a much lower dose. Typically, these two drugs would never be used together, because they both are going after the same binding proteins on molecules. We are finding that there is a real synergistic relationship between the two drugs.
Q: What was the source of the islet cells?
A: For each patient, we have used islets from two donor pancreases. Our goal is to improve the way in which we isolate islets, so that we can transplant islets from one donor to one recipient. That is happening already.
Q: This once again underscores the need for organ donation.
A: It certainly underscores the need to improve donor education and increase the number of organ donors in Canada and around the world. However, there are other issues related to finding an unlimited source, and we are working on alternative ways as well. One possibility is to develop an islet that we can grow in culture. There has been some press recently about a beta cell line growing in culture. Those cells are like cancerous cells in a way; they keep growing and producing insulin. I don't think that is the long-term goal, because that is only one cell. Islets are multicellular tissues that contain multiple cell types. Cells that secrete insulin are one of the types, but there are also cells that secrete a substance called glucagon. It is the relationship between the insulin and the glucagon that provides people with good, stable control of their glucose. The two act on each other. And there are other cells, such as the hormone somatostatin, that control both insulin and glucagon secretion. We are transplanting the whole machinery in an islet transplant, as opposed to just one single cell type.
Xenotransplantation is also an area that we are working on. We have some models here with Drs. Korbutt and Rajotte, who have developed some pig models that are providing what we think is a good source. But there ate immunological problems as well as ethical issues related to xenotransplantation.
Q: We have worked with Novartis in the past, one of the leaders in this field of pig organ transplant. They published a study recently on the porcine endogenous retrovirus (PERV) and its transmission in patients who had received pig transplants of various kinds over many years, and none had experienced the virus expression.
A: Exactly.
Q: Do you think that use of xenotransplant tissues, such as islet cells from pigs, might occur soon?
A: I think it is years away, unfortunately.
Q: How long will patients be on the antirejection drugs?
A: These patients are on the immunosuppressants for the rest of their lives. We are working on alternative drug therapies so that we can possibly transplant them and give patients a short course of new agents or antibodies--something for which humans can eventually develop a tolerance.
Q: Was the transplant procedure complicated?
A: No, transplant was the easy part. The difficult part is the islet isolation to get enough cells to transplant.
Q: And that is what you do?
A: That is my focus. That procedure takes four to five people six hours to retrieve the purified islets from the pancreas for transplant. The actual islet-transplant procedure is very simple.
We work with the interventional radiologist here at the University of Alberta. They transhepatically go through the liver with a very small needle into the portal vein, inserting a small catheter. We then collect the islets in a 60 cc syringe and inject them. The patient is awake, and the procedure takes about 15 minutes. It is becoming a one-day procedure, and patients are going home the next day.
Q: Have all patients returned to work?
A: Certainly. We have transplanted lawyers who are back practicing. The first couple of patients were teachers, and they couldn't teach, because their diabetes was so bad that they were basically bedridden. They are now healthy and productive members of society. That is very, very rewarding to know that we have made a significant impact on the lives of these people.
Q: Were the people in the study severe cases of Type 1 diabetes?
A: Yes, these are people with very "brittle" diabetes. By that, I mean that they cannot control their blood sugars despite optimal insulin therapies. They were measuring their blood glucose levels 10 to 15 times a day and injecting insulin three or four times a day or more. While trying their best, their bodies are just not reacting, and they are experiencing wide fluctuations. They also experience hypoglycemic unawareness, having lost that sensation of becoming low--and that situation is very scary. If driving or cooking, for example, they could basically black out as a result of their diabetes and not be aware of it.
Q: How quickly did you notice the results?
A: After the islet transplant, the results came very quickly. The sustained insulin independence we are watching now. They are all doing great. The one-year oral glucose tolerance test in our first patient is completely normal. That shows us we transplanted enough viable cells that they are doing well; the cells are not falling off, and you are not seeing an immunological destruction.
Q: The breakthrough has been described as a miracle.
A: Certainly, people keep throwing the word "cure" around. As scientists, we know that we are no way near a cure. There is still much work that needs to be done. But these patients talk about cure. And certainly for them, it is a cure. Their lives are totally changed. Instead of diabetes controlling them, they are controlling their diabetes.
Q: The first question that people with Type 1 diabetes will ask is, "How can I become a part of a clinical trial?"
A: We are now screening and enrolling patients who meet our criteria--brittle diabetes and hypoglycemic unawareness--into our trial here in Edmonton. There are also centers being selected for trials in the United States. The Immune Tolerance Network is funding four transplants in each of these different centers. Their goal is to duplicate what we have been able to accomplish here in Edmonton.
Q: And that is called the Edmonton protocol at this point?
A: Yes. The Edmonton Protocol. It contains the protocol that we have been discussing--from the way we isolate islets to the immunosuppressant agents used to the selection criteria for patients.
Q: Does the Immune Tolerance Network have a Web site where people can learn more about the trial?
A: Yes. You can access their Web site at www.paramount.bsd.uchicago.edu, or immunetolerance.org.
Q: The side effects of the procedure were minor, mainly mouth sores.
A: Yes, and they resolved themselves. We were using a liquid formulation of one of the drugs, and by changing it to a pill formulation, we no longer have seen that side effect.
Q: And you are working with additional patients in your trial?
A: Yes, the NEJM talked about 7. James Shapiro, M.D., reporting on the trial in Chicago, talked about 8. But we have done 11 now.
Q: In reading the NEJM study, I noticed that you administered vitamins E, [B.sub.6], and A in the regimen. What was the significance of this?
A: We were trying to cover all our bases by providing enough vitamins.
Q: Were these three vitamins specific to Type 1 diabetic deficiency?
A: No. They are just general vitamins that we thought important. A group in Germany has used a vitamin cocktail for a while.
Q: Will the vitamins continue to be part of the protocol?
A: I believe so, yes.
Q: Since diabetes is an autoimmune disorder, did you learn anything about autoimmune disorders during the course of the trial?
A: Our focus right now is restoring euglycemia, or normal blood glucose concentration, in these patients. We hope that immunological and autoimmune destruction of the islets will not occur using this type of immunosuppression. We, along with collaborators here at the university, are working on a vaccine to prevent diabetes.
Q: When will islet cell transplantation be widely available?
A: As the centers in Europe and the United States begin their trials, the momentum will increase and mushroom out to other centers in the U.S. and Canada. It is coming. For the very first time, we have been able to show that islet transplants do work. That is what the field needed. In the past, there was an 8 percent success rate; it was really more anecdotal than clinical success.
Q: This is amazing. The procedure will have a profound impact on Type 1 diabetes.
A: Yes, as long as we address the issue of having adequate sources of the tissue, which is the biggest challenge for us right now. And we must continue to improve the way we isolate the islet so that we can use one donor pancreas to one recipient. If we accomplish that, right off the bat we have doubled the number of transplants that we can do. And if we work with organ-donor organizations to educate others, we can increase donations, and that will have a big impact as well. Everyone knows someone with diabetes.
Q: We hope that our readers will help you through organ donations.
A: Thank you very much.
If you would like to contact the Islet Transplant Program for more information.
Islet Transplant Program University of Alberta Hospital 8440-112th Street Edmonton, AB T6G 2B7 Email: isletprogram@med.ualberta.ca Website: www.med.ualberta.ca/ research/groups/islet/
If you are interested in participating in U.S. trials, you can contact the Immune Tolerance Network for more information.
Immune Tolerance Network Suite 200 5743 South Drexel Avenue Chicago, IL 60637 Email: islet-info@immunetolerance.org Website: http://www.immunetolerance.org/
RELATED ARTICLE: One Patient's Story: "Nothing Short of a Miracle"
The Post spoke with Robert Teskey, one of the first seven patients in the Edmonton trial. Since age 14, Robert has been dealing with the daily struggles that people with Type 1 diabetes face.
POST: How are you feeling?
TESKEY: I am feeling great.
POST: What was your life like prior to the islet cell transplant procedure?
TESKEY: I was diagnosed with Type 1 diabetes in 1960, so I have been diabetic for almost 40 years. I was on insulin the entire time. In the early days, I started with one injection a day, then later on two, followed by three, then four injections a day. Over 40 years, I probably had 40,000 injections--a number that gets people's attention. Most people identify the difficulty with Type 1 diabetes as being "on the needle." The fact is that for most diabetics, injections aren't the big issue; they get pretty used to it after that many times around the block. For me, the real difficulty was that I was beginning to run into long-term, significant complications of dia
In my case, I had heart blockages that had to be reamed out with angioplasty. Coupled with cardiovascular problems, I had low blood sugar, or hypoglycemia. With low blood sugar, your brain just shuts down. If you are fortunate enough to be able to anticipate and predict when these situations are going to occur, you can fix them easily by consuming some sugar. But I was running into situations when I didn't feel them coming on. By the time others around me noticed that there was a problem, I was pretty far gone. In the community, we call that insulin reaction.
I began complaining to my specialist about my problems. With traditional insulin therapy, there is not a whole lot than can be done. They can do some fine-tuning, but the reality is that these are issues that are not easily resolved under traditional insulin therapy. About 15 months ago, I received a call telling me that a research team at the University of Alberta was going to try islet cell transplant again, and they asked me if I would be interested in becoming part of the test group.
POST: What happened in the procedure?
TESKEY: The procedure itself is very straightforward if you set aside all of the tests and aspects that relate to the research study. They take donor pancreases and, through a complex process, separate the islet, or insulin-producing, cells from the rest of the pancreatic tissue. The islets are a very small part of the total pancreas tissue mass. They end up with a couple of teaspoons of a cloudy yellow liquid that they inject into the main vein going into the liver. The vein carries the cells to the liver where the cells root, then start doing their thing.
POST: How long was it before you began noticing a difference?
TESKEY: Immediately, within a day.
POST: How often did they check your insulin levels after the transplant?
TESKEY: During those first days, probably every hour or hour and a half. The first procedure that I had, my insulin requirement dropped to about 35 percent of what it had been previously, and that effect was immediate.
POST: How many injections were you taking each day?
TESKEY: Four injections a day and a total of about 80 units of insulin.
POST: How did this dramatic shift feel?
TESKEY: It was amazing. You can hardly believe it. You keep expecting that something will reverse itself quickly. But it happened very quickly, and there was no turning back. After the last transplant, I have not had one injection of insulin.
POST: How long ago was that?
TESKEY: In August 1999.
POST: The implications of this procedure for people like you with Type 1 diabetes are very profound
TESKEY: "Profound" is a very good choice of words. I view it as nothing short of miraculous.
POST: Do you feel that you are any different from other Type 1 diabetics in the same situation?
TESKEY: No. I feel some sense of guilt because I know that there are literally hundreds of thousands of other people around the world and North America whose situation is no different than mine. I just happened to be at the right place at the right time and fortunate enough to be in this study.
POST: Have you experienced any complications or side effects?
TESKEY: Since the first transplant, I have not had a low blood sugar episode. Part of what the cells do is to monitor the insulin level in the blood. They pump out insulin, but perhaps even more than that, they determine how much you need and simply provide it exactly when required in the exact amount you need. Even though I was taking some insulin, the cells then started to take that externally supplied insulin into account in terms of how much they pumped out.
POST: Could you tell me how your life has changed since the transplant? Were you and your family on any kind of special diet that may have changed since the procedure?
TESKEY: Certainly, my diet is significantly more relaxed. I was never quite as rigid in following a sugar-free diet as some people are. I am now in a position where I can eat anything. If I choose not to eat, I have that choice as well. For many diabetics, it is not so much about not eating as it is being required to eat because you have to be taking, in food to use up the insulin injected externally.
There is a dramatic difference in my life--having the ability not to have to eat, following a strict timetable during the day, not having to test my blood sugar levels, not having to take injections of insulin, and being able to sleep in. And most of all, not always trying to have to predict or anticipate when one of these low-blood-sugar episodes might be on the horizon.
POST: What drugs are you taking at this time?
TESKEY: I am on two antirejection drugs, which are key to the success of the program. Both drugs have not traditionally been used. Cyclosporine, or a derivative of cyclosporine and steroids, is what has usually been used. The drugs that we are using are different from other families of drugs, achieve the necessary immunosuppressive effect, are taken in very low doses, and have very few side effects.
POST: What side effects have you experienced?
TESKEY: The side effects are small compared to the benefits. Almost everyone in the study experienced mouth sores in the initial stage. But as they got the drug levels to the appropriate dose, those went away and were certainly not a permanent problem. The other side effect is so minor that it is embarrassing to note. The fingernails get thin, so you lose your ability to use them in the traditional way. They are just not strong enough anymore to pull things or pick things up.
POST: Are you back at work?
TESKEY: I worked throughout the whole procedure. Some of the patients had been in a serious enough condition that they had been off work for a long time. I was able to return to work within a day after discharge from the hospital, which gives a sense of the relatively minor nature of the procedure.
POST: What does your family think about the success?
TESKEY: I am a widower. My wife was killed a couple of years ago by a drunk driver. But I do have two children at home--18 and 21.
POST: Do either of your children have diabetes?
TESKEY: No.
POST: What do your kids think?
TESKEY: They are even more amazed. After my wife was gone, they were the people who had to worry about whether I was going to pass out in the night. For them, it has also been a great relief.
POST: To date, all the transplants have been successful. The first patient has been out of the trial for about 1 1/2 years.
TESKEY: Not quite a year and a half. The first one, Brian Best, had his transplant in late March 1999. Two others occurred in the following two months. I was number four, and I had mine in June of last year.
POST: We hope the Edmonton protocol reaches people with Type 1 diabetes around the world. It would save lives.
TESKEY: It really would. There are two very important messages in this story. One is clearly the need for more organ donations. Everyone knows at least one other person who is an insulin diabetic and would benefit from this treatment. My fondest hope is that sharing my story will raise awareness of the need for people to donate their organs. In terms of major roadblocks, it is the supply of donors. There may be ways that this can be solved other than getting more donors, but right now donors are key.
Of course, the other issue equally important is medical research funding. These developments just don't happen. A number of centers in the United States--Miami, Minnesota, Chicago--have been working on islet cell transplants. But research costs money.
POST: When the procedure becomes more widely available, do you think it will be expensive?
TESKEY: I think that ultimately it will be very inexpensive. If they are able to clone the cells and not have to rely on organ donations and get over the need for antirejection drugs, my hope is that any youngster diagnosed as a new diabetic would simply turn up at their doctor's office, get their injection, go home, and that would be the end of the matter. It would be less traumatic than, say, having a serious cold.
POST: That would have made a big difference in your life, wouldn't it?
TESKEY: It really would. I have been fortunate in that I have not let diabetes stand in the way of a full and fulfilling life. But the reality is that it is only when you have been freed as I have that you begin to realize how much difference not having all of this diabetic management makes in your life.
COPYRIGHT 2000 Saturday Evening Post Society
COPYRIGHT 2000 Gale Group
See also
Types of Diabetes
Type 1 Diabetes
Type 2 Diabetes
Gestational Diabetes
Juvenile Diabetes
Diabetes Insipidus
Feline Diabetes
Note:
This diabetes health education project is supported by Chong's Health Care at http://www.cljhealth.com, one of the leading companies in the discovery of alternative medicines for diabetes.
All contents copyright ? Los Angeles Chinese Learning Center, unless otherwise noted. Website Hosting Diabetes
Diabetes News: Finding the Causes of Diabetes, Medicinal Herbs Used in China Are Shown to Lower Glucose Levels. Please also read Yu Xiao San 8805 on Type I and Type II Diabetes and Hypoglycemic Effects of Selected Ingredients
In response to the growing health burden of diabetes mellitus (diabetes), the diabetes community has three choices: prevent diabetes; cure diabetes; and take better care of people with diabetes to prevent devastating complications. All three approaches are actively being pursued by the US Department of Health and Human Services.
Both the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) are involved in prevention activities. The NIH is involved in research to cure both type 1 and type 2 diabetes, especially type 1. CDC focuses most of its programs on being sure that the proven science is put into daily practice for people with diabetes. The basic idea is that if all the important research and science are not made meaningful in the daily lives of people with diabetes, then the research is, in essence, wasted.
Several approaches to "cure" diabetes are being pursued:
Pancreas transplantation
Islet cell transplantation (islet cells produce insulin)
Artificial pancreas development
Genetic manipulation (fat or muscle cells that don?t normally make insulin have a human insulin gene inserted ? then these "pseudo" islet cells are transplanted into people with type 1 diabetes).
Each of these approaches still has a lot of challenges, such as preventing immune rejection; finding an adequate number of insulin cells; keeping cells alive; and others. But progress is being made in all areas.
(From the National Institute of Health)
Diabetes Type 1: One Step Closer To A Cure - Interview
Patrick Perry, Saturday Evening Post
Will successful islet cell transplantation spell the end of Type 1 diabetes for millions?
To some, it is nothing short of a miracle.
"I remember thinking, If someone could give me a present, I would ask for just one day that I wasn't diabetic," said junior-high-school teacher Mary Anna Kralj-Pokerznik, 30. "Now I've had 13 months. It's like being released from a prison you've been in for years and years."
The teacher was one of seven patients who received a revolutionary treatment for Type 1 diabetes, an autoimmune disease in which the body destroys the insulin-producing beta cells in the pancreas.
News of the successful islet cell-transplant procedure for Type 1 diabetes spread to every news program and newspaper in the world. And diabetes researchers tout the treatment as a major step forward in treating the disease; some even hail it as a "cure."
Certainly, the islet cell-transplant procedure, known as the Edmonton protocol, ushers in an era of renewed hope for the more than one million people with Type 1 diabetes. Patients with the disorder must constantly monitor their blood sugars and endure multiple insulin injections daily just to survive.
The islet cell transplant procedure was pioneered in clinical trials at the University of Alberta, and the antirejection protocol was designed by James Shapiro, M.D., director of the clinical islet transplant program.
The novel protocol departs from previous attempts at islet cell transplant in that it uses a novel steroid-free combination of three drugs to prevent rejection of the transplanted cells, a procedure that appears to prevent the autoimmune diabetes from returning.
Like many great medical discoveries, the new approach came to Dr. Shapiro as a hunch. While sitting in a hotel room on a rainy day in Baltimore, he sat down and wrote the protocol. He had been asked to return to the University of Alberta after a hiatus at the University of Maryland--and needed to come up with a new method of forcing the human body to produce its own insulin.
"I told myself I was going to give it one last try," said Shapiro, who with many other researchers from around the world had tried repeatedly to transplant islets to severe insulin-dependent patients with little success.
Using the steroid-free protocol, seven of seven patients in the trial--some of whom were administering up to 15 injections a day--are now insulin-independent, free of daily insulin injections and constant worry. The results of the trial were published in the New England Journal of Medicine.
"My life has totally changed," said Robert Teskey, a Type 1 diabetic who was part of the landmark trial. "Gone is the need to think about how much insulin to take at every meal. Gone is the need to test my blood endlessly. Gone is the need to mentally calculate the nutritional, and particularly the complex-carbohydrate and simple-sugar, content of every meal or snack. Most of all, gone is the fear of an incapacitating insulin reaction."
The research team, led by a 28-year veteran of islet cell transplant, Ray Rajotte, Ph.D., will now teach the Edmonton Protocol to centers around the world. Clinical trials in the United States and Europe will begin shortly.
To learn more about the breakthrough, we spoke with Jonathan Lakey, Ph.D., director of the Human Islet Isolation Laboratory at the University of Alberta and coauthor of the NEJM study, about the innovative transplant procedure.
Q: Could you tell us about the successful clinical study of islet transplantation for Type 1 diabetics?
A: The results showed that islet transplantation can reverse the hyperglycemia experienced in Type 1 diabetes and that islet transplantation is now a viable option for the treatment of diabetes. In the clinical trial reported in the NEJM, we had a series of seven patients who received islet cells isolated from donor pancreases. The cells were transplanted into these patients through the hepatic portal vein. The transplanted islets flowed through the vein up to the liver, where they were engrafted and are now secreting insulin. Basically, all patients are totally off insulin. Their hemoglobin A1C, which is a marker for glucose function, is normal and has remained normal for all follow-up visits. The longest patient has been insulin-free about 15 months; the average is about 12 months.
Q: Were you surprised by the results of the trial?
A: We were very surprised. But it is what we hoped we would see. When we did the first transplant about 15 months ago, we were ecstatic. The second transplant helped confirm what we were seeing in the first patient, as did the third, fourth, and fifth. It developed faster than we had hoped.
Q: Why the portal vein in the liver, since islet cells normally would reside in the pancreas?
A: The liver still provides portal blood drainage, meaning that the islets--if in the pancreas and still functioning--would be secreting insulin, and the insulin would be going through the portal system up through the liver. So you still get portal vein drainage. The reason that we didn't transplant into the pancreas is that putting a needle into the portal vein is much simpler than trying to go into the pancreas.
Q: How are these islet cells able to take residence in the liver and reproduce?
A: Basically, the liver is like a big filter, so the transplanted cells flow into the liver and get clogged, in the small bed of the liver. Once there, they start secreting insulin from that point on and develop a whole new blood supply as well. There has been some work in animal models showing this. It is really quite amazing.
Q: Previous attempts at islet cell transplantation have been somewhat disappointing. What did your research team do differently in this trial?
A: In the laboratory--and this is my area--we have been able to develop techniques to improve the recovery of both the number of islets and the functional viability of human islets. We changed the traditional method of isolating islets and developed newer techniques that deliver more viable cells for transplant. We accomplished that in a number of different ways. First, we worked with industry to develop a product, an enzyme blend called Liberase, that is used to help digest the donor pancreas into its tissue components. We have also developed a method to load that enzyme into the pancreas, using a regulated perfusion system that controls the flow of the temperature and the pressure. We feel that this method allows maximal delivery of the enzyme into the pancreas.
The second step was the dissociation. Using enzymes and mechanical methods, we break the pancreas apart, then separate the islets from the exocrine tissue based on differences in their density. That method has worked very well and consistently. We have also eliminated animal products. Typically, fetal calf serum is added during various steps of the islet isolation process to inactivate enzymes, as well as to provide nutrients.
Q: Does eliminating animal products reduce the possibility of rejection?
A: We think that it might. In the past, the islets have all been isolated with fetal calf serum. This fetal calf serum could be coding the islets and act like a big red flag to the body to destroy these cells when injected. We hope that by not using animal serum, we will not elicit such an active immune response.
Q: What immunosuppressants did you use?
A: Typically, all islet transplants in the past have used steroids. We eliminated steroids from our transplant protocol. We are using two new drugs; one is called Rapimmune, made by Wyeth-Ayerst, and the other is Tacrolimus, or FK506. Tacrolimus has been around for a while, but we are using it at a much lower dose. Typically, these two drugs would never be used together, because they both are going after the same binding proteins on molecules. We are finding that there is a real synergistic relationship between the two drugs.
Q: What was the source of the islet cells?
A: For each patient, we have used islets from two donor pancreases. Our goal is to improve the way in which we isolate islets, so that we can transplant islets from one donor to one recipient. That is happening already.
Q: This once again underscores the need for organ donation.
A: It certainly underscores the need to improve donor education and increase the number of organ donors in Canada and around the world. However, there are other issues related to finding an unlimited source, and we are working on alternative ways as well. One possibility is to develop an islet that we can grow in culture. There has been some press recently about a beta cell line growing in culture. Those cells are like cancerous cells in a way; they keep growing and producing insulin. I don't think that is the long-term goal, because that is only one cell. Islets are multicellular tissues that contain multiple cell types. Cells that secrete insulin are one of the types, but there are also cells that secrete a substance called glucagon. It is the relationship between the insulin and the glucagon that provides people with good, stable control of their glucose. The two act on each other. And there are other cells, such as the hormone somatostatin, that control both insulin and glucagon secretion. We are transplanting the whole machinery in an islet transplant, as opposed to just one single cell type.
Xenotransplantation is also an area that we are working on. We have some models here with Drs. Korbutt and Rajotte, who have developed some pig models that are providing what we think is a good source. But there ate immunological problems as well as ethical issues related to xenotransplantation.
Q: We have worked with Novartis in the past, one of the leaders in this field of pig organ transplant. They published a study recently on the porcine endogenous retrovirus (PERV) and its transmission in patients who had received pig transplants of various kinds over many years, and none had experienced the virus expression.
A: Exactly.
Q: Do you think that use of xenotransplant tissues, such as islet cells from pigs, might occur soon?
A: I think it is years away, unfortunately.
Q: How long will patients be on the antirejection drugs?
A: These patients are on the immunosuppressants for the rest of their lives. We are working on alternative drug therapies so that we can possibly transplant them and give patients a short course of new agents or antibodies--something for which humans can eventually develop a tolerance.
Q: Was the transplant procedure complicated?
A: No, transplant was the easy part. The difficult part is the islet isolation to get enough cells to transplant.
Q: And that is what you do?
A: That is my focus. That procedure takes four to five people six hours to retrieve the purified islets from the pancreas for transplant. The actual islet-transplant procedure is very simple.
We work with the interventional radiologist here at the University of Alberta. They transhepatically go through the liver with a very small needle into the portal vein, inserting a small catheter. We then collect the islets in a 60 cc syringe and inject them. The patient is awake, and the procedure takes about 15 minutes. It is becoming a one-day procedure, and patients are going home the next day.
Q: Have all patients returned to work?
A: Certainly. We have transplanted lawyers who are back practicing. The first couple of patients were teachers, and they couldn't teach, because their diabetes was so bad that they were basically bedridden. They are now healthy and productive members of society. That is very, very rewarding to know that we have made a significant impact on the lives of these people.
Q: Were the people in the study severe cases of Type 1 diabetes?
A: Yes, these are people with very "brittle" diabetes. By that, I mean that they cannot control their blood sugars despite optimal insulin therapies. They were measuring their blood glucose levels 10 to 15 times a day and injecting insulin three or four times a day or more. While trying their best, their bodies are just not reacting, and they are experiencing wide fluctuations. They also experience hypoglycemic unawareness, having lost that sensation of becoming low--and that situation is very scary. If driving or cooking, for example, they could basically black out as a result of their diabetes and not be aware of it.
Q: How quickly did you notice the results?
A: After the islet transplant, the results came very quickly. The sustained insulin independence we are watching now. They are all doing great. The one-year oral glucose tolerance test in our first patient is completely normal. That shows us we transplanted enough viable cells that they are doing well; the cells are not falling off, and you are not seeing an immunological destruction.
Q: The breakthrough has been described as a miracle.
A: Certainly, people keep throwing the word "cure" around. As scientists, we know that we are no way near a cure. There is still much work that needs to be done. But these patients talk about cure. And certainly for them, it is a cure. Their lives are totally changed. Instead of diabetes controlling them, they are controlling their diabetes.
Q: The first question that people with Type 1 diabetes will ask is, "How can I become a part of a clinical trial?"
A: We are now screening and enrolling patients who meet our criteria--brittle diabetes and hypoglycemic unawareness--into our trial here in Edmonton. There are also centers being selected for trials in the United States. The Immune Tolerance Network is funding four transplants in each of these different centers. Their goal is to duplicate what we have been able to accomplish here in Edmonton.
Q: And that is called the Edmonton protocol at this point?
A: Yes. The Edmonton Protocol. It contains the protocol that we have been discussing--from the way we isolate islets to the immunosuppressant agents used to the selection criteria for patients.
Q: Does the Immune Tolerance Network have a Web site where people can learn more about the trial?
A: Yes. You can access their Web site at www.paramount.bsd.uchicago.edu, or immunetolerance.org.
Q: The side effects of the procedure were minor, mainly mouth sores.
A: Yes, and they resolved themselves. We were using a liquid formulation of one of the drugs, and by changing it to a pill formulation, we no longer have seen that side effect.
Q: And you are working with additional patients in your trial?
A: Yes, the NEJM talked about 7. James Shapiro, M.D., reporting on the trial in Chicago, talked about 8. But we have done 11 now.
Q: In reading the NEJM study, I noticed that you administered vitamins E, [B.sub.6], and A in the regimen. What was the significance of this?
A: We were trying to cover all our bases by providing enough vitamins.
Q: Were these three vitamins specific to Type 1 diabetic deficiency?
A: No. They are just general vitamins that we thought important. A group in Germany has used a vitamin cocktail for a while.
Q: Will the vitamins continue to be part of the protocol?
A: I believe so, yes.
Q: Since diabetes is an autoimmune disorder, did you learn anything about autoimmune disorders during the course of the trial?
A: Our focus right now is restoring euglycemia, or normal blood glucose concentration, in these patients. We hope that immunological and autoimmune destruction of the islets will not occur using this type of immunosuppression. We, along with collaborators here at the university, are working on a vaccine to prevent diabetes.
Q: When will islet cell transplantation be widely available?
A: As the centers in Europe and the United States begin their trials, the momentum will increase and mushroom out to other centers in the U.S. and Canada. It is coming. For the very first time, we have been able to show that islet transplants do work. That is what the field needed. In the past, there was an 8 percent success rate; it was really more anecdotal than clinical success.
Q: This is amazing. The procedure will have a profound impact on Type 1 diabetes.
A: Yes, as long as we address the issue of having adequate sources of the tissue, which is the biggest challenge for us right now. And we must continue to improve the way we isolate the islet so that we can use one donor pancreas to one recipient. If we accomplish that, right off the bat we have doubled the number of transplants that we can do. And if we work with organ-donor organizations to educate others, we can increase donations, and that will have a big impact as well. Everyone knows someone with diabetes.
Q: We hope that our readers will help you through organ donations.
A: Thank you very much.
If you would like to contact the Islet Transplant Program for more information.
Islet Transplant Program University of Alberta Hospital 8440-112th Street Edmonton, AB T6G 2B7 Email: isletprogram@med.ualberta.ca Website: www.med.ualberta.ca/ research/groups/islet/
If you are interested in participating in U.S. trials, you can contact the Immune Tolerance Network for more information.
Immune Tolerance Network Suite 200 5743 South Drexel Avenue Chicago, IL 60637 Email: islet-info@immunetolerance.org Website: http://www.immunetolerance.org/
RELATED ARTICLE: One Patient's Story: "Nothing Short of a Miracle"
The Post spoke with Robert Teskey, one of the first seven patients in the Edmonton trial. Since age 14, Robert has been dealing with the daily struggles that people with Type 1 diabetes face.
POST: How are you feeling?
TESKEY: I am feeling great.
POST: What was your life like prior to the islet cell transplant procedure?
TESKEY: I was diagnosed with Type 1 diabetes in 1960, so I have been diabetic for almost 40 years. I was on insulin the entire time. In the early days, I started with one injection a day, then later on two, followed by three, then four injections a day. Over 40 years, I probably had 40,000 injections--a number that gets people's attention. Most people identify the difficulty with Type 1 diabetes as being "on the needle." The fact is that for most diabetics, injections aren't the big issue; they get pretty used to it after that many times around the block. For me, the real difficulty was that I was beginning to run into long-term, significant complications of dia
In my case, I had heart blockages that had to be reamed out with angioplasty. Coupled with cardiovascular problems, I had low blood sugar, or hypoglycemia. With low blood sugar, your brain just shuts down. If you are fortunate enough to be able to anticipate and predict when these situations are going to occur, you can fix them easily by consuming some sugar. But I was running into situations when I didn't feel them coming on. By the time others around me noticed that there was a problem, I was pretty far gone. In the community, we call that insulin reaction.
I began complaining to my specialist about my problems. With traditional insulin therapy, there is not a whole lot than can be done. They can do some fine-tuning, but the reality is that these are issues that are not easily resolved under traditional insulin therapy. About 15 months ago, I received a call telling me that a research team at the University of Alberta was going to try islet cell transplant again, and they asked me if I would be interested in becoming part of the test group.
POST: What happened in the procedure?
TESKEY: The procedure itself is very straightforward if you set aside all of the tests and aspects that relate to the research study. They take donor pancreases and, through a complex process, separate the islet, or insulin-producing, cells from the rest of the pancreatic tissue. The islets are a very small part of the total pancreas tissue mass. They end up with a couple of teaspoons of a cloudy yellow liquid that they inject into the main vein going into the liver. The vein carries the cells to the liver where the cells root, then start doing their thing.
POST: How long was it before you began noticing a difference?
TESKEY: Immediately, within a day.
POST: How often did they check your insulin levels after the transplant?
TESKEY: During those first days, probably every hour or hour and a half. The first procedure that I had, my insulin requirement dropped to about 35 percent of what it had been previously, and that effect was immediate.
POST: How many injections were you taking each day?
TESKEY: Four injections a day and a total of about 80 units of insulin.
POST: How did this dramatic shift feel?
TESKEY: It was amazing. You can hardly believe it. You keep expecting that something will reverse itself quickly. But it happened very quickly, and there was no turning back. After the last transplant, I have not had one injection of insulin.
POST: How long ago was that?
TESKEY: In August 1999.
POST: The implications of this procedure for people like you with Type 1 diabetes are very profound
TESKEY: "Profound" is a very good choice of words. I view it as nothing short of miraculous.
POST: Do you feel that you are any different from other Type 1 diabetics in the same situation?
TESKEY: No. I feel some sense of guilt because I know that there are literally hundreds of thousands of other people around the world and North America whose situation is no different than mine. I just happened to be at the right place at the right time and fortunate enough to be in this study.
POST: Have you experienced any complications or side effects?
TESKEY: Since the first transplant, I have not had a low blood sugar episode. Part of what the cells do is to monitor the insulin level in the blood. They pump out insulin, but perhaps even more than that, they determine how much you need and simply provide it exactly when required in the exact amount you need. Even though I was taking some insulin, the cells then started to take that externally supplied insulin into account in terms of how much they pumped out.
POST: Could you tell me how your life has changed since the transplant? Were you and your family on any kind of special diet that may have changed since the procedure?
TESKEY: Certainly, my diet is significantly more relaxed. I was never quite as rigid in following a sugar-free diet as some people are. I am now in a position where I can eat anything. If I choose not to eat, I have that choice as well. For many diabetics, it is not so much about not eating as it is being required to eat because you have to be taking, in food to use up the insulin injected externally.
There is a dramatic difference in my life--having the ability not to have to eat, following a strict timetable during the day, not having to test my blood sugar levels, not having to take injections of insulin, and being able to sleep in. And most of all, not always trying to have to predict or anticipate when one of these low-blood-sugar episodes might be on the horizon.
POST: What drugs are you taking at this time?
TESKEY: I am on two antirejection drugs, which are key to the success of the program. Both drugs have not traditionally been used. Cyclosporine, or a derivative of cyclosporine and steroids, is what has usually been used. The drugs that we are using are different from other families of drugs, achieve the necessary immunosuppressive effect, are taken in very low doses, and have very few side effects.
POST: What side effects have you experienced?
TESKEY: The side effects are small compared to the benefits. Almost everyone in the study experienced mouth sores in the initial stage. But as they got the drug levels to the appropriate dose, those went away and were certainly not a permanent problem. The other side effect is so minor that it is embarrassing to note. The fingernails get thin, so you lose your ability to use them in the traditional way. They are just not strong enough anymore to pull things or pick things up.
POST: Are you back at work?
TESKEY: I worked throughout the whole procedure. Some of the patients had been in a serious enough condition that they had been off work for a long time. I was able to return to work within a day after discharge from the hospital, which gives a sense of the relatively minor nature of the procedure.
POST: What does your family think about the success?
TESKEY: I am a widower. My wife was killed a couple of years ago by a drunk driver. But I do have two children at home--18 and 21.
POST: Do either of your children have diabetes?
TESKEY: No.
POST: What do your kids think?
TESKEY: They are even more amazed. After my wife was gone, they were the people who had to worry about whether I was going to pass out in the night. For them, it has also been a great relief.
POST: To date, all the transplants have been successful. The first patient has been out of the trial for about 1 1/2 years.
TESKEY: Not quite a year and a half. The first one, Brian Best, had his transplant in late March 1999. Two others occurred in the following two months. I was number four, and I had mine in June of last year.
POST: We hope the Edmonton protocol reaches people with Type 1 diabetes around the world. It would save lives.
TESKEY: It really would. There are two very important messages in this story. One is clearly the need for more organ donations. Everyone knows at least one other person who is an insulin diabetic and would benefit from this treatment. My fondest hope is that sharing my story will raise awareness of the need for people to donate their organs. In terms of major roadblocks, it is the supply of donors. There may be ways that this can be solved other than getting more donors, but right now donors are key.
Of course, the other issue equally important is medical research funding. These developments just don't happen. A number of centers in the United States--Miami, Minnesota, Chicago--have been working on islet cell transplants. But research costs money.
POST: When the procedure becomes more widely available, do you think it will be expensive?
TESKEY: I think that ultimately it will be very inexpensive. If they are able to clone the cells and not have to rely on organ donations and get over the need for antirejection drugs, my hope is that any youngster diagnosed as a new diabetic would simply turn up at their doctor's office, get their injection, go home, and that would be the end of the matter. It would be less traumatic than, say, having a serious cold.
POST: That would have made a big difference in your life, wouldn't it?
TESKEY: It really would. I have been fortunate in that I have not let diabetes stand in the way of a full and fulfilling life. But the reality is that it is only when you have been freed as I have that you begin to realize how much difference not having all of this diabetic management makes in your life.
COPYRIGHT 2000 Saturday Evening Post Society
COPYRIGHT 2000 Gale Group
See also
Types of Diabetes
Type 1 Diabetes
Type 2 Diabetes
Gestational Diabetes
Juvenile Diabetes
Diabetes Insipidus
Feline Diabetes
Note:
This diabetes health education project is supported by Chong's Health Care at http://www.cljhealth.com, one of the leading companies in the discovery of alternative medicines for diabetes.
All contents copyright ? Los Angeles Chinese Learning Center, unless otherwise noted. Website Hosting Diabetes
Monday, January 18, 2010
Sunday, January 17, 2010
Tummietote by Tallygear......
This versatile pack/belt holds your insulin pump, the paradigm if you use the omnipod, a cell phone, i-pod, snacks, test kit, money and debit/credit card. http://www.tallygear.com/ and
http://www.insulinpumppack.com/
http://www.insulinpumppack.com/
LIVE GOOD,
deb
Saturday, January 16, 2010
clinical trials of the artificial pancreas.
Q: Can you tell me more about participating in the artificial pancreas trials? Where are they being performed and do they study children?
A: This is a great question . The JDRF is currently supporting research at a number of sites. Clinical studies are being performed at:
The University of Colorado Denver, Aurora, CO - Dr. Peter Chase (Pediatric site)
Stanford University, Palo Alto, CA - Dr. Bruce Buckingham (Pediatric site)
The Sansum Diabetes Institute, Santa Barbara, CA - Dr. Lois Jovanovic
The University of Virginia, Charlottesville, VA - Dr. William Clarke (Pediatric site)
Cambridge University, Cambridge, U.K. - Dr. David Dunger
Oregon Health & Sciences University, Portland, OR - Dr. Kenneth Ward
Boston University/Massachusetts General Hospital, Boston, MA - Dr. Steven Russell
Yale University, New Haven, CT - Dr. Stuart Weinzimer (Pediatric Site)
University of Montpellier, Montpellier, France - Dr. Eric Renard
University of Padova, Padova, Italy - Dr. Angelo Avogaro
Schneider Children's Medical Center of Israel, Petah Tikva, Israel - Dr. Moshe Phillip (Pediatric Site)
Much more information about this consortium including more detailed descriptions of the work each group is performing, publication references, and information about the sites can be found on the website of the consortium coordinating center - the Jaeb Center. The Jaeb Center is led by Dr. Roy Beck and facilitates and enhances the research at each of the clinical sites by supporting regulatory processes, clinical trial design, data collection and interpretation, and device (pump/sensor) integration into the studies among other things.Each of these sites is currently enrolling patients for closed--loop studies (though many are limiting the number of patients they are enrolling). Each of the studies currently is performed at what we call the CRC--the Clinical Research Center--which is a controlled hospital-like environment. These studies are helping both the diabetes doctors and the algorithm developers optimize the approaches we plan to use when we move to less controlled outpatient (real world) studies. We hope that in the next 12 months the first outpatient studies will begin.As you can see, the group that JDRF is funding consists of both pediatric and adult endocrinologists (note that the pediatric sites will sometimes see patients above 18 years of age). Children can participate in the artificial pancreas trials. Each site has descriptions of the eligibility criteria for their respective studies - that is, who can and can not participate.This is an exciting time for closed-loop research. I suggest you take a look at the following video describing one artificial pancreas trial participant's experience. It is amazing! I also suggest you sign up for the JDRF Clinical Trials Connection. This is an easy way to learn about trials that you or your loved one may be eligible to participate in - artificial pancreas and across the spectrum of diabetes research.
The JDRF is the only organization of its kind devoted to finding a cure for adults and children living type 1diabetes. For four decades we’ve concentrated our support on advancing the most promising work ofresearchers, scientists, physicians, academic medical centers, and more across the globe.Our dedication to finding a cure focuses not just on this long-term need, but also on improving everyone’s lifetoday by working to reduce the life-threatening aspects of diabetes and providing emotional support andpractical resources for the day-to-day issues surrounding the disease. Not only has JDRF accelerated diabetes research, we are a leader in diabetes advocacy. JDRF’s advocacycampaign resulted in insurance coverage for continuous glucose monitors by the nation’s largest healthplans and many regional ones. JDRF has also persuaded the Food and Drug Administration to make the artificial pancreas an agency priority.Every day JDRF brings together people who have type 1 diabetes, or have a connection to someone with type1, and offers them support, advocacy and hope. With our local chapters across the U.S. and the world and ournew online community, you can connect with individuals who understand what it’s like to live with diabetes 24hours a day, and join in the efforts to improve life and find a cure.Since its founding in 1970 by parents of children with type 1 diabetes, the JDRF has awarded more than $1.3billion to diabetes research, and funded more than 1,000 centers, grants in laboratories,hospitals, and industry,and fellowships in 22 countries. No other organization today is as uniquely poised as the JDRF to accelerate and drive breakthroughs from thelab to the bedside of type 1 diabetes patients. We stand together at a remarkable point in history where a better quality of life for all, and a cure,are withinreach in our lifetime. We welcome you to join the JDRF and make a real difference in the lives of everyoneliving with diabetes.
JDRF.ORG
JDRF ...dedicated to finding a cure.
JDRF E-Newsletters
One way to accelerate the path to a cure is making sure everyone has the latest information. The JDRF is proud to be the leading source of news, breakthroughs and advancements to the type 1 diabetes community. Here you’ll find links to a variety of JDRF online sources to help keep you in the know.
Research E-NewsletterGet the latest information about research on type 1 diabetes and its complications
One way to accelerate the path to a cure is making sure everyone has the latest information. The JDRF is proud to be the leading source of news, breakthroughs and advancements to the type 1 diabetes community. Here you’ll find links to a variety of JDRF online sources to help keep you in the know.
Research E-NewsletterGet the latest information about research on type 1 diabetes and its complications
Thursday, January 14, 2010
so much optimism in the air....
JDRF's Life with Diabetes E-Newsletter Special Edition January 2010
JDRF in Groundbreaking Partnership with Animas to Develop First-Generation Artificial Pancreas System
The development of an artificial pancreas—a fully automated system to dispense insulin to people with diabetes based on real-time changes in blood sugar levels—would be among the most revolutionary advancements in treating type 1 diabetes. Today, JDRF took the first steps on that path, with the groundbreaking announcement of an innovative partnership with Animas Corporation, a Johnson & Johnson company that is a leading pump manufacturer, to develop a first-generation artificial pancreas: an automated system to help people with type 1 diabetes better control their disease.
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 (FDA) for approval.
First Steps Towards an Artificial Pancreas
“If successful, the development of this first-generation system would begin the process of automating how people with diabetes manage their blood sugar,” said JDRF President and CEO Alan Lewis. “Ultimately, an artificial pancreas will deliver insulin as needed, minute-by-minute, throughout the day to maintain blood sugar within a target range. But even this early system could bring dramatic changes in the quality of life for the three 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 and night.”
New Automated SystemThe 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.
Here’s an example of how this first-generation device would work: The wearer will still need to manually tell the pump to deliver insulin at times, such as around meals, and adjust insulin delivery rates based on activity, illness, and other variables. But the system would “treat to range,” that is, try to keep blood sugar within a set range between, for example, 80 mg/dL and 180mg/dL by automatically increasing insulin delivery when it senses blood glucose going above the high end of the range, and slowing down or turning off insulin delivery when it sensed blood glucose levels moving below the low end of the range.
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.
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.
DexCom, Inc., a leading manufacturer of CGM devices, will supply the CGM technology for the system to be developed by JDRF and Animas.
Reducing High and Low Blood Sugar“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, JDRF’s Research Director of the 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 http://ssomail.charter.net/do/redirect?url=http%253A%252F%252Fecho4.bluehornet.com%252Fct%252F6534109%253A7655466290%253Am%253A1%253A323950375%253A4512359A0996CE7CF5A34952D76B648C. 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.
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 FDA, which along with JDRF and the 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.
Juvenile Diabetes Research Foundation International26 Broadway 14th floorNew York, NY 10004 Phone:(800) 533-CURE (2873)Fax: (212) 785-9595E-mail: info@jdrf.org
LIVE GOOD,
deb
JDRF in Groundbreaking Partnership with Animas to Develop First-Generation Artificial Pancreas System
The development of an artificial pancreas—a fully automated system to dispense insulin to people with diabetes based on real-time changes in blood sugar levels—would be among the most revolutionary advancements in treating type 1 diabetes. Today, JDRF took the first steps on that path, with the groundbreaking announcement of an innovative partnership with Animas Corporation, a Johnson & Johnson company that is a leading pump manufacturer, to develop a first-generation artificial pancreas: an automated system to help people with type 1 diabetes better control their disease.
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 (FDA) for approval.
First Steps Towards an Artificial Pancreas
“If successful, the development of this first-generation system would begin the process of automating how people with diabetes manage their blood sugar,” said JDRF President and CEO Alan Lewis. “Ultimately, an artificial pancreas will deliver insulin as needed, minute-by-minute, throughout the day to maintain blood sugar within a target range. But even this early system could bring dramatic changes in the quality of life for the three 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 and night.”
New Automated SystemThe 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.
Here’s an example of how this first-generation device would work: The wearer will still need to manually tell the pump to deliver insulin at times, such as around meals, and adjust insulin delivery rates based on activity, illness, and other variables. But the system would “treat to range,” that is, try to keep blood sugar within a set range between, for example, 80 mg/dL and 180mg/dL by automatically increasing insulin delivery when it senses blood glucose going above the high end of the range, and slowing down or turning off insulin delivery when it sensed blood glucose levels moving below the low end of the range.
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.
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.
DexCom, Inc., a leading manufacturer of CGM devices, will supply the CGM technology for the system to be developed by JDRF and Animas.
Reducing High and Low Blood Sugar“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, JDRF’s Research Director of the 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 http://ssomail.charter.net/do/redirect?url=http%253A%252F%252Fecho4.bluehornet.com%252Fct%252F6534109%253A7655466290%253Am%253A1%253A323950375%253A4512359A0996CE7CF5A34952D76B648C. 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.
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 FDA, which along with JDRF and the 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.
Juvenile Diabetes Research Foundation International26 Broadway 14th floorNew York, NY 10004 Phone:(800) 533-CURE (2873)Fax: (212) 785-9595E-mail: info@jdrf.org
LIVE GOOD,
deb
Wednesday, January 13, 2010
new view window for the insulin pump pack....
Donna has been in touch with a woman who is a type 1 in Atlanta, Ga., she has her own diabetes blog, i am unsure of the name of it, i will post it once i know. She is on a pump but also has a CGM ( continuous glucose monitor) she is a counselor and can't leave clients so she asked Donna if it were possible to have a view window in the pack so she doesn't have to remove the pump from the tummietote pouch. Donna embraced this idea right away, before days end we had a modification. A Tallygear tummietote with a clear view window, no need to take pump from the pocket, and you can deliver insulin right through the soft clear plastic window. I will post a picture after i take one of my niece, Tallia's pack tomorrow......very cool stuff!
LIVE GOOD,
Deb
LIVE GOOD,
Deb
Tuesday, January 12, 2010
1HAPPYDIABETIC
we recently met a very interesting person, believe it or not through a craigslist ad..... it is Bill Woods, the publisher of a blog called 1happydiabetic. He was very interested in trying out the tummietote. Donna sent one along to him to test out at the gym..... he has tried it out and loves it.....and wants to have a contest.......details still in the works where several people will win tallygear tummietotes, stay tuned there will be something on 1happydiabetic , tudiabetes.com and possibly also youtube.....we will keep you posted.
LIVE GOOD<
deb
LIVE GOOD<
deb
Monday, January 11, 2010
tummietote by tallygear
My sister Lynne is pictured with the pack on and she is using it to run. She ran her first marathon in October 2009 using the pack.LIVE GOOD,
deb
creative pack for my neices insulin pump
My niece, Tallia, is a very active 10 year old child who was diagnosed with juvenile diabetes in September of 2007.
Tallia went on the insulin pump in November of 2008. An insulin pump is about the size of a blackberry or a larger i-pod and it is connected to her body by a plastic line that is secured to an injection site in her body. The pump isn't small or light-weight. My sister Donna, Tallia's mom tried many different ways to secure the pump to her clothing. We tried to make pouches, we bought many pouches on the market, we stuffed the pump in a sock and safety-pinned to inside of her shirt, secured it with velcro....many different ideas.
Donna, the dreamer with all the ideas in the family came up with an idea to make Tallia's life with diabetes better. She designed an insulin pump pack that is comfortable, secure and discreet. The pack is made of comfortable spandex blend and can be worn under clothes directly on your skin or on the outside of clothes. Wearing it on the outside of clothes is actually stylish right now because it looks just like the top of yoga pants!
See her designs at http://www.tallygear.com/
We will continue to update you on news , events and ideas on our quest of living good with diabetes, and the effort to find a cure.
LIVE GOOD,
Deb
Tallia went on the insulin pump in November of 2008. An insulin pump is about the size of a blackberry or a larger i-pod and it is connected to her body by a plastic line that is secured to an injection site in her body. The pump isn't small or light-weight. My sister Donna, Tallia's mom tried many different ways to secure the pump to her clothing. We tried to make pouches, we bought many pouches on the market, we stuffed the pump in a sock and safety-pinned to inside of her shirt, secured it with velcro....many different ideas.
Donna, the dreamer with all the ideas in the family came up with an idea to make Tallia's life with diabetes better. She designed an insulin pump pack that is comfortable, secure and discreet. The pack is made of comfortable spandex blend and can be worn under clothes directly on your skin or on the outside of clothes. Wearing it on the outside of clothes is actually stylish right now because it looks just like the top of yoga pants!
See her designs at http://www.tallygear.com/
We will continue to update you on news , events and ideas on our quest of living good with diabetes, and the effort to find a cure.
LIVE GOOD,
Deb
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