Hospital to pioneer new diabetes treatment

The first to try a procedure on humans with diabetes that is being tested on monkeys in Florida.

By Barbara Williams

The Record (Hackensack N.J

HACKENSACK, N.J. — Doctors from Hackensack University Medical Center hope to find a cure for diabetes as they embark on a partnership with one of the world’s leading researchers for the disease.

The hospital will be the first to try a procedure on humans with diabetes that is currently being tested on monkeys in Florida — a collaborative effort with Dr. Camillo Ricordi, a pioneer in the field and the scientific director and chief academy officer of the University of Miami Diabetes Research Institute.

“Dr. Ricordi wants to find a cure for diabetes, and he doesn’t care how many people are involved in the process or share in the credit,” said Dr. Michael Shapiro, Hackensack’s chief of organ transplantation and leader of the diabetes partnership. “This collaboration will do great things for diabetes research.”

Diabetes occurs when the body cannot produce or properly use insulin, a hormone that helps the body metabolize glucose into energy and control blood sugar levels.

With Type 1 diabetes, sometimes called juvenile diabetes and the most serious form of the disease, the body’s immune system destroys the cells from the pancreas that make insulin, called islets. People with Type 2 diabetes make insulin, but their body doesn’t utilize it correctly and production of it typically declines as they age. More than 25 million Americans have diabetes, and about 3 million of those suffer with Type 1.

Health care experts expect the number of diabetics to increase dramatically, as obesity can trigger Type 2 diabetes and Americans continue to get heavier.

Living for years with unregulated blood sugar levels can cause a myriad of symptoms, some as severe as blindness, poor circulation that leads to limb amputation, and kidney failure.

Typical treatment for diabetic patients includes insulin pumps, injections and oral medications. Transplanting islets from deceased donors is sometimes effective, but it frequently triggers other complications because the islets need to be implanted in the liver. The number of organ donors also falls way short of the number of diabetics who would benefit from a transplant.

In this latest study with monkeys, Ricordi loads islets on a disc and then implants them in the abdomen, rather than in the liver.

“The challenge is we’re dealing with an autoimmune disease so we have to replace or get cells to regenerate that were destroyed,” Ricordi told dozens of HUMC executives, physicians and health care workers this week. “And the key is to do this without a lifelong regimen of autoimmune rejection drugs.”

Based on the success with the primates, Shapiro is hoping to have four patients undergo the procedure in early 2012, though recruitment hasn’t begun. The ideal patients will be those who aren’t responding to other treatments.

Physicians attending the announcement highlighted Ricordi’s expertise and advances in treatment of the disease.

His creation, the Ricordi Chamber, is so well-known in the field that it was mentioned in a recent episode of the medical drama “Grey’s Anatomy.” Critical for a transplant, it is able to efficiently separate islets from the pancreas.

But successfully transplanting the islets will only be part one of the cure. Researchers need to figure out how to create islets in the lab so there will be enough to treat all diabetic patients who need them. Another research team is working on that endeavor in the Miami institute.

Still, the partnership has hospital executives determined and diabetic patients hopeful.

“I’m absolutely sure we’ll find a cure,” said Robert Garrett, president and chief executive of HUMC.

Stephanie Stone, who was diagnosed with diabetes at 10 and is now 18, attended the announcement with her Franklin Lakes, N.J., family.

“I’m optimistic for the future,” Stephanie said. “If this isn’t a cure, it sounds like it’s a better treatment before a cure is found.”

Artificial Pancreas Shows Promise In Type 1 Diabetes Treatment

(RTTNews) – A new study from researchers at the University Cambridge of Metabolic Research Laboratories suggests that a computer assisted artificial pancreas may aid in the treatment of Type 1 diabetes. In the study 24 adult diabetes patients used the device, which helps regulate glucose control overnight.

Half of the patients consumed a moderate meal and the other half consumed a larger meal and then both used the device over night. The researchers found that the entire group enjoyed a 28 percent increase in the amount of time glucose levels were in the ideal range.

“This study is more good news, and we’re seeing an evolution of more and more sophistication in this closed loop study,” Aaron Kowalski, assistant vice president for treatment therapies at the Juvenile Diabetes Research Foundation, tells businessweek.com.

“What we’re doing now is pressing these systems in real situations with the goal of getting to the next step of testing at home.”

by RTT Staff Writer

High-fat diet is awful, but it may reverse diabetes-related kidney damage

By Eryn Brown, Los Angeles Times

A high-fat “ketogenic” diet may reverse the kidney damage caused by diabetes, a study published online Wednesday by the journal PLoS One reports.

Past research has shown that lowering blood sugar through diet can prevent kidney failure but not reverse it in patients with diabetes.  Lead author Charles Mobbs, a neuroscientist at the Mount Sinai Medical Center in New York City, said that this study — in which mice were fed a high-fat diet of 5% carbohydrate, 8% protein and a whopping 87% fat — was the first to show that dietary intervention alone is enough to reverse kidney failure caused by diabetes.

Amy Tenderich: A Mighty Force Empowering Diabetes Patients by Riva Greenberg

Amy Tenderich is a journalist/patient blogger who started DiabetesMine.com after her diagnosis with type 1 diabetes in 2003.

She advocates on many fronts for people with diabetes, daily empowers e-patients and her site is one of the top health blogs in the world.

I interviewed Amy some years ago and blew my only interview due to digital recorder (alright, operator) failure. She was gracious enough to let me interview her again.

This is the eighth in my series of profiles on diabetes change leaders.

Q: How did you discover you had diabetes?

Amy Tenderich: It was just a few months after the birth of my third daughter. I had lost nearly all my pregnancy weight and was delighted — and fairly exhausted. I was fitting into my favorite jeans and my husband was joking with me about my girlish figure.

But I noticed my vision going blurry and I began feeling parched and famished all the time. I also had to run to the bathroom every 10 minutes! Meanwhile, the weight loss became exponential. I would wake up in the morning skinnier than I was the day before. Then I knew something was wrong. I landed in the hospital for a week completely dehydrated and depleted and close to falling into a coma.

Q: How did you and your family respond to your diagnosis?

AT: I was completely shocked. Although my father had type 2 diabetes and I had been told late in my pregnancy that I had “borderline” gestational diabetes, it never occurred to me in a million years that I could develop this life-threatening form of “juvenile” diabetes.

My husband was my anchor. He immediately said, “We’ll tackle this together.” He supported my full range of emotions from my bawling on his shoulder, to shouting out in anger, to my fierce determination to conquer this thing and not let it ruin the pleasantries of our lives.

Q: What made you start DiabetesMine.com?

AT: Suddenly my life became all about poking my finger for blood glucose tests a dozen times a day, injecting insulin at least six times a day, and constantly worrying about food, my activity level and how all of this affected my glucose readings. The doctors had me on far too much insulin at first so I was having severe lows after every meal. I thought I was experiencing a nervous breakdown!

I felt overwhelmed and intensely alone so I went looking for some “real-life” advice and for other patients to connect with online. But in 2003 all I could find was a dizzying array of medical journal articles and bad-news headlines — almost all of them incomprehensible for a new patient like me. Where were the other people living with diabetes?

I decided that with my background as a journalist I could perhaps create my own version of a place for patients on the Web — essentially the site that I myself was looking for. Fortunately, new software had just been introduced allowing anybody to create an online journal.

I called the blog DiabetesMine as a play on words, “Diabetes is mine, I’m stuck with it” and the notion of “a gold mine of straight talk and encouragement for people living with diabetes.” I’ve been astonished (blessed, even) at the following it’s gained.

Q: What are you most passionate about and where besides DiabetesMine are you leaving your footprint?

AT: Recently I joined Alliance Health Networks as V.P. of Patient Advocacy. Now there’s a title that reflects a new paradigm! I am passionate about empowering patients. Alliance has built a Facebook-like online community called DiabeticConnect.com which I’ve been involved with for several years.

One thing that’s really useful about DiabeticConnect, in addition to the features, recipe and book reviews, are the product reviews. Patients get to rate diabetes items like they might rate shoes or household items on Amazon.com. Where else can you find that kind of real-world input from patients on medical tools?

I also launched, a few years ago, an annual diabetes innovation competition that has sparked national attention about the need for better-designed medical devices that actually fit into people’s lifestyles. It’s called the DiabetesMine Design Challenge.

This year we’re offering $25,000 in prize money for the best new concepts for tools, devices or web applications that improve life with diabetes. Tools that would be most helpful, most comfortable and most appealing for our day-to-day lives with this illness. We welcome anyone who’s got an idea be it a patient, parent, caregiver, student, entrepreneur, health care provider, designer or engineer.

The reality is that only a handful of design firms design around “human factors.” Most have no idea how to get the patient perspective.

In addition to our Design Challenge, next fall DiabetesMine.com and IDEO, one of our Design Challenge partners, will be holding a Diabetes Innovation Summit. It will bring together patient advocates and medical device designers.

Q: What do you consider your mission?

AT: My personal mission is to do my very best to help educate and connect people, lobby for the best tools and treatments and generally be a conduit of information and assistance between diabetes patients and the powers that be (medical establishment, pharmaceutical industry).

Q: What do you see as the power of social media and where do you see it going in five years?

AT: The power of social media for people living with chronic health conditions is that it adds the “human factor” to our health care system, which is something pharmaceutical companies and health insurers can’t provide — and doctors and nurses just don’t have the time for.

Through social media we’re able to connect with each other and enjoy an ongoing source of emotional support and camaraderie, education and shared information, and a platform for grassroots advocacy. Plus patients have a collective voice they never had before.

Where it will all head in the next five years, I wish I could tell you. Things change so quickly in the Internet world!

Q: Is the online diabetes community different than other online communities?

AT: I personally believe that blogs and online social networks are practically tailor made for the needs of people with diabetes. Diabetes is such a unique disease. It’s chronic yet largely controllable by the patient with a lot of work and perseverance.

The biggest issue most of us face with the challenge of our 24/7 self-care is isolation. Most of us at some point feel desperate to talk with someone who “gets it.” There’s also the issue of staying motivated day-in and day-out, all to prevent some far-off goal of not going blind one day! With blogs and social networks we can reach out to each other and share information and support in a much richer way than we ever could before.

Q: What’s your opinion about the type 1 vs type 2 divide?

AT: I think it’s unfortunate that we sometimes snipe at each other. As Jeff Hitchcock, founder of ChildrenwithDiabetes.com, likes to say, it’s diabetes that’s the enemy, not this group or that group. The end-game is the same for all of us so I hope we can find ways to work together to make life better for all of us.

Q: What would you like to see policy makers do differently regarding diabetes?

AT: The single most important goal ought to be transforming our system from a “sick care” system that pays primarily for treatment of acute events like dialysis and amputation to an actual “health care” system that invests in disease prevention and education. Seems like a no-brainer, doesn’t it? But I realize it always boils down to the financial incentive issue. The question of who pays and why?

Q: What would you like to see medical device makers do differently?

AT: Despite all the talk about making things “patient-centered,” it seems there really are no established ‘best practices’ for achieving patient involvement in the design process of products for chronic illness care.

Typically companies create something very clinical or engineer-driven and then pay lots of money to set up “focus groups” where they fill a room with patients, give ’em the gadget and just watch what buttons they push. That’s a pretty backwards way to go about it.

Patients need to be involved in conceptualizing their own tools. This is of course the whole drive behind the DiabetesMine Design Challenge. We’re sourcing ideas from people who actually use the tools.

Q: You’re such a knowledgeable patient, is there anything you struggle with having diabetes?

AT: The never-endingness of it. And the fact that I have to constantly discipline myself to “behave better” than all the non-diabetics around me who can eat and exert themselves anytime they want, freely. I wrote a post about it recently called “Losing Control.” It’s about my biggest frustrations of late!

Q: How do you get through the tough days?

AT: I try not to beat myself up. On some tough days I try to “take a step back,” recognize that I’m having a bad day and give myself a little break or a non-edible treat of some sort, like maybe getting my nails done or taking a walk in the woods. Other days I just tell myself, “You’ll just have to write this one off!” and know that I will start fresh trying my best the next day.

Q: Do you find anything positive about having diabetes?

AT: Without a doubt it’s the people I’ve met. Passionate, exemplary, fun people who are pushing through this disease to accomplish amazing things. I’ve met diabetic Olympians, rock stars, authors, artists, adventure-travel experts, acrobats — you name it — and also scores of lovely “ordinary” people like me who manage their diabetes with grace and compassion.

I often find myself saying, “If I just had this stupid illness and didn’t have my online diabetes world, now that would be a bummer!”

Diabetes has also opened a world of opportunities to me including the chance to co-author a book a few years ago called “Know Your Numbers, Outlive Your Diabetes” with Dr. Richard Jackson of Joslin Diabetes Center in Boston. He’s become a close friend of mine.

Q: Could you have imagined when you began this work that a patient could be so influential educating other patients and influencing product manufacturers and policy makers?

AT: I’m just astounded to think that one sick mom in California could reach out to so many fellow patients, create a community, and actually turn the whole thing into a business.

It’s helped me feel less alone and less frightened about living with diabetes, given me a purpose in life and I’m thrilled to have found myself at the center of an enormous army of increasingly well-informed patients.

Together we’re challenging the traditional model of health care in this country.

With free access to all sorts of medical information and by asking the right questions and demanding the latest and greatest drugs and devices, patients can drive our own care for the first time in history. We can end the stranglehold of doctors and health insurance companies on information and treatment options.

Q: What’s the single thing you haven’t yet done that you’d like to?

AT: I want to do many things. I want to travel to lands I haven’t seen, watch my kids grow up and dance at their weddings, train for a Century Ride and actually finish it. In the diabetes world, I’d like to attend Diabetes Training Camp one day and live to tell the tale!

Riva is the author of “50 Diabetes Myths That Can Ruin Your Life and the 50 Diabetes Truths That Can Save It” and “The ABC’s Of Loving Yourself With Diabetes.” Visit her web site diabetesstories.com.

 

 

FDA accepts application for Astra diabetes drug

LONDON

AstraZeneca PLC and Bristol-Myers Squibb Co. say the U.S. Food and Drug Administration has accepted for review a new drug application for diabetes drug dapagliflozin.

The companies added on Tuesday that a marketing authorization application for dapagliflozin has also been validated by the European Medicines Agency.

Dapagliflozin is an oral drug intended to be taken once a day. It is designed to help type 2 diabetes patients excrete glucose and related calories in their urine. That would help prevent glucose from building up in the body.

Type 1 Diabetes Research Consortium Meets ~ Harvard Stem Cell Institute

The Type 1 Diabetes Research Consortium, a multi-institutional collaborative program of The Leona M. and Harry B. Helmsley Charitable Trust, held its annual meeting in New York City in October. Established in 2009 to better understand the causes of type 1 diabetes and explore potential therapies, the consortium encompasses 11 institutions and 45 investigators through 28 grants totaling $21.8 million.

HSCI Co-Director Douglas Melton, PhD (far left), is one of four members of the consortium’s Scientific Steering Committee. With Melton are (left to right): committee member Rudy Leibel, MD, Columbia University; Helmsley Charitable Trust Trustee David Panzirer; Program Director Dana Ball; and committee members Matthias Hebrok, PhD, University of California, San Francisco, and Mark Atkinson, PhD, University of Florida.

RETAIN Trial for Newly Diagnosed Type 1 Diabetes Enrolls Patients

Immune Tolerance Network study will examine effect of anti-inflammatory drug

BOSTON and SEATTLE – March 2, 2011 – The Immune Tolerance Network (ITN) has enrolled the first participant in a two-part, phase II clinical research trial evaluating the effect of intravenous alpha 1-antitrypsin (AAT) on preserving the function of insulin-producing cells in patients recently diagnosed with type 1 diabetes. ARALAST NP is one marketed formulation of AAT. The Research Trial of ARALAST NP in New-onset Type 1 Diabetes (RETAIN) is seeking 82 eligible participants at 15 clinical research centers across the U.S. The first participant was enrolled at Emory University/Children’s Hospital of Atlanta.

The RETAIN trial is being conducted by the ITN, and supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and by the Juvenile Diabetes Research Foundation (JDRF). Additional funding for the study is provided by the Special Statutory Funding Program for Type 1 Diabetes Research, a special appropriation for research on the prevention and cure for type 1 diabetes. Baxter Healthcare Corporation is providing the ARALAST NP supply for the study.

Type 1 diabetes is a chronic autoimmune disease. It develops when the T cells of the immune system mistakenly attack and destroy the body’s own insulin-producing beta cells in the pancreas. The body uses insulin to maintain normal levels of blood glucose.

“This is an exciting time for autoimmune disease research—particularly in type 1 diabetes,” said Gerald Nepom, M.D., director of the ITN. “The ITN’s mission is to conduct innovative, high impact studies in hopes of improving therapy and gaining a better understanding of the mechanisms of immune function and disease pathogenesis. Concepts of immune tolerance have become much more sophisticated but translating them into therapeutic success is a daunting challenge.” Nepom also pointed out that “research trials like RETAIN are very important because new therapeutic options for recently diagnosed type 1 diabetes patients are urgently needed to attempt to stop the disease process.”

The RETAIN trial is evaluating the ability of ARALAST NP (from Baxter Healthcare Corporation) to halt the progression of type 1 diabetes. ARALAST NP is an anti-inflammatory drug and an inhibitor of a class of enzymes called serine proteinases, which break down protein molecules. The drug may also affect immune cells that are involved in the development of type 1 diabetes. Other investigators have already shown that AAT can reverse new-onset diabetes in non-obese diabetic mice and inhibit the rejection of transplanted islet cells in animal models of diabetes.

“We are very excited that after two years of planning, we can begin our study to determine if AAT can slow the progression of newly diagnosed type 1 diabetes,” said Gordon Weir, M.D., the principal investigator of the RETAIN trial.

“The FDA approved this drug class more than 20 years ago,” added Weir, who is co-head of the section on Islet Cell & Regenerative Biology at Joslin Diabetes Center and Professor of Medicine at Harvard Medical School. “Although it has never been tested in patients with diabetes, previous studies have shown that ARALAST NP is very effective in animals with this disease.” If the drug is found to be effective in patients with diabetes, they may require less injected insulin and their blood glucose levels may be easier to control, thus leading to fewer long-term complications.

RETAIN is a two-part phase II clinical trial. In Part I, all participants will know they are receiving ARALAST NP, which will be tested to see if it is safe and well tolerated for those with new-onset type 1 diabetes. After Part I is completed, enrollment in Part II will begin. Participants in Part II will be assigned randomly to one of two groups, one to receive the drug and the other to receive a placebo.

The RETAIN trial is currently seeking participants between the ages of 16 to 35 years old who have been diagnosed with type 1 diabetes mellitus within three months of enrollment in the trial. Eventually, the enrollment age will be expanded to include children between 8 and 15 years old. Enrollment is expected to continue for approximately two years.

More information about the trial and participating clinical research centers can be found at www.retainstudy.org or www.clinicaltrials.gov.

• Joslin Diabetes Center; Boston, MA
• Naomi Berrie Diabetes Center at Columbia University; New York, NY
• Barbara Davis Center for Childhood Diabetes at University of Colorado Denver; Aurora, CO
• Nationwide Children’s Hospital; Columbus, OH
• Pacific Northwest Research Institute at University of Washington; Seattle, WA
• Massachusetts General Hospital; Boston, MA
• Yale University; New Haven, CT
• Children’s Hospital of Philadelphia; Philadelphia, PA
• University of California San Diego / Rady Children’s Hospital; San Diego, CA
• University of Massachusetts Medical Center; Worcester, MA
• Children’s Mercy Hospital; Kansas City, MO
• University of Maryland Medical Center; Baltimore, MD
• Emory University/ Children’s Hospital of Atlanta; Atlanta, GA
• Atlanta Diabetes Associates; Atlanta, GA
• University of Iowa; Iowa City, IA

About the Immune Tolerance Network

The Immune Tolerance Network is an international consortium of doctors, scientists, government officials and support staff dedicated to finding new, safer treatments for diseases and conditions affecting the immune system.
Funded by the National Institute of Allergy and Infectious Diseases and the Juvenile Diabetes Research Foundation International, the ITN develops and conducts clinical studies of immune tolerance therapies—highly targeted treatments designed to prevent disease-causing immune responses, without compromising the natural protective properties of the immune system. For more information about the ITN, visit www.immunetolerance.org

Roche and Animas Recall

Diabetes Health Staff
Feb 26, 2011

A couple of diabetes recalls are in the works, one for a group of insulin cartridges manufactured by Animas and another for the entire line of ACCU-CHEK® FlexLink Plus infusion sets, manufactured by Roche.

Animas has proactively decided to recall and replace five lots of its 2.0 mL insulin pump cartridges because the company learned that some of the cartridges were leaking insulin. The lot numbers are B201575, B201576, B201581, B201582, and B201583. If you are one of the customers affected by this recall, you should have already been contacted by Animas regarding what to do. For more information, visit http://www.animas.com/urgent-news.

The FDA website reports that Roche is recalling the ACCU-CHEK® FlexLink Plus infusion set “because of the potential for under delivery of insulin due to a kinked/bent cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. If this remains unnoticed, this can result in under delivery leading to elevation of blood glucose levels.” If you use this infusion set, the company advises you to stop using it and to contact your healthcare providers if you have any questions. You can also call Roche’s customer service line at 1-800-688-4578 to receive information regarding obtaining alternative infusion sets.

Sources: FDA website
Animus website

Renoprotection Not Sufficient for Patients With Diabetes

Patients with type 1 diabetes and macroalbuminuria remain at high risk for developing end-stage renal disease despite the increased use of renoprotective treatment, according to a study published online Feb. 25 in the Journal of the American Society of Nephrology.

FRIDAY, Feb. 25 (HealthDay News) — Patients with type 1 diabetes and macroalbuminuria remain at high risk for developing end-stage renal disease (ESRD) despite the increased use of renoprotective treatment, according to a study published online Feb. 25 in the Journal of the American Society of Nephrology.

Elizabeth T. Rosolowsky, M.D., of the Joslin Diabetes Center in Boston, and colleagues examined the risk of ESRD in 423 white patients with type 1 diabetes and macroalbuminuria between 1991 and 2004. The researchers examined the predictors of ESRD and the patients’ mortality rates pre- and post-ESRD. Ninety-eight percent of the cohort was followed up until 2008.

The researchers found that 172 patients developed ESRD over the duration of the study. They also found that 29 patients without ESRD died; most of these patients were aged 36 to 52 and had endured diabetes between 21 and 37 years. Renoprotective treatment use increased from 56 to 82 percent during the 15 years of follow-up, and a significant improvement was seen in patients’ blood pressures and lipid levels over this time; however, there was little change in the risk of ESRD and pre-ESRD death. The cumulative mortality risk for ESRD was 52 percent, and 11 percent for pre-ESRD. Seventy post-ESRD deaths occurred during the study, with similar mortality rates during the 1990s and 2000s. Pre-emptive kidney transplants reduced mortality.

“Despite the widespread adoption of renoprotective treatment, patients with type 1 diabetes and macroalbuminuria remain at high risk for ESRD, suggesting that more effective therapies are desperately needed,” the authors write.

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Bret Michaels talks about life with diabetes

By Eryn Browns, Los Angeles Times

Yes, he’s had numerous stints on reality TV and millions of records sold — but singer Bret Michaels may be best known as the star of a real-life medical drama.

In April 2010, he had an emergency appendectomy. Less than two weeks later, he had a brain hemorrhage. A month after that, he had a stroke, caused by a hole in his heart. He had surgery to repair the heart defect in January.

Michaels also has Type 1 diabetes, which was diagnosed when he was 6 years old. He spoke about how he deals with that disease in a recent interview with Diabetes Health magazine.

Keeping blood sugar levels in check while touring with his band isn’t easy, Michaels said. He carries “a large supply of boring food” with him on the road — including turkey, tomatoes, celery and peanut butter — and keeps an exercise bike on his bus for those days when he can’t stop at a gym.

He checks his blood sugar eight times a day. During concerts, his band mates know to look out for signs that his blood sugar is too low. They throw in extended instrumental solos as needed so that Michaels can run offstage, check his blood sugar and get a drink of orange juice.

Michaels has two daughters, one of whom is pre-diabetic. He said he’s trying to teach them the importance of staying active.

A pet peeve? “The battle it takes to get the plastic off a new glucose tablet container,” he said.

Advice for loved ones of diabetics? “The calmer you react [in a crisis] the better.”

What he’ll do when they find a cure for the disease? “I’m going to make every night Halloween.”