JDRF News Blog

New Study Discovers Cause of Pain in Diabetic Neuropathy

Gary — Fri, 18 May 2012 14:27:30 GMT

Diabetic neuropathy, or nerve damage, is one of the most painful complications faced by people with diabetes. Over time, high blood sugar associated with diabetes may lead to nerve damage. In the legs and feet, this nerve damage frequently results in numbness or lack of sensation, but it can also lead to intense pain. Until now, researchers have not understood exactly why nerve disease leads to this pain, which is difficult to treat and can negatively affect a person’s quality of life.

Now, a new study has discovered one cause of pain for people with nerve damage from diabetes. The results of the study, funded in part by JDRF through a center grant and conducted by an international collaboration of researchers including Dr. Michael Brownlee and the late Dr. Angelika Bierhaus, were published in the journal Nature Medicine. In the study, conducted in mice, the researchers found that a molecule called methylglyoxal (MG), which is produced excessively from glucose in people with diabetes, contributes to the pain. In the mice in the study, the excess MG bound to a protein called Nav 1.8, which is found in a specific type of nerve cell responsible for the sensation of pain. When this bond occurs, the nerve becomes locked in the “on” position, resulting in the feeling of pain that accompanies nerve damage in people with diabetes.

Since researchers now better understand what causes the severe pain associated with diabetic neuropathy, they can use that knowledge to develop new treatments. According to Dr. Brownlee, the study “opens the way for new diabetic neuropathy treatments targeting methylglyoxal accumulation.” One possible approach is to regulate an enzyme called glyoxalase 1, which may be able to prevent or remove the modifications caused by MG and therefore eliminate the pain. According to Dr. Helen Nickerson, JDRF’s senior scientific program manager for treatment therapies, “better understanding the role of methyglyoxal could lead to potential therapy for more than one complication of diabetes.”

This study highlights one of the approaches JDRF is taking in its research strategy to prevent complications. This approach is to identify pathways triggered by high glucose levels over time that eventually lead to complications, and attempt to intervene in the process as early as possible to prevent them.

JDRF Uses Clinical Trials Connection to Play Matchmaker

Michael — Mon, 07 May 2012 16:21:39 GMT

Recently, the Wall Street Journal published an article about matching patients with their ideal clinical trials, which focused on the growing trend of patient advocacy groups and their efforts to encourage clinical trial participation. In addition to featuring programs being implemented by the Michael J. Fox Foundation for Parkinson’s Research and the Alzheimer’s Association, it also briefly mentioned JDRF’s program that many people with type 1 diabetes may already know about.

The Clinical Trials Connection (CTC) was started in 2009 as a way to connect people affected by type 1 diabetes (T1D) with up-to-date research progress and clinical trial opportunities. Similar to an online dating service, CTC enables people to search the clinicaltrials.gov database of trials (including JDRF-funded trials) that involve diabetes cures and treatments to get information, make comparisons, and - if they are interested - directly contact trial centers.

To get started on CTC, a person with T1D or a friend or loved one can register at trials.jdrf.org and provide basic information such as current age, age at diagnosis, and the area in which they would like to find a trial. Through this web site, people can provide criteria like the type of trial they are interested in, how long they have had diabetes, and how far they'd be willing to travel, and the site will let them know about studies that match those characteristics. The site also offers flexibility by allowing the searcher to look for clinical trials on behalf of a loved one with T1D, or look for a clinical trial for him or herself, even if they don’t have T1D.

The idea of using the internet to find clinical trials is not new. Clinicaltrials.gov, hosted by the United States National Library of Medicine, an arm of the National Institutes of Health, has been in existence online since 2000 and provides information on all clinical trials from its registry of over 90,000 studies. However, CTC takes the vast, and often times daunting world of clinical research, and pares it down to the information that is most important for people with T1D.

Human clinical trials are a critical phase toward the development for a drug or therapy before becoming available to the market. Participants in clinical trials not only stand to reap any potential benefit offered by the therapy, they are also helping to pave the way for new drugs, therapies and ultimately a cure for T1D.

Since its beginning, CTC has found an audience that is ready and eager to take part in clinical trials. Support for the website has been strong since its inception, and the number of registered users continues to grow as more people become aware of the importance of participating in a clinical trial, and are eager to make a difference in their lives and the lives of others with T1D.

T1D reversed in mice using engineered gut bacteria

Tara Wilcox-Ghanoonparvar — Fri, 27 Apr 2012 14:03:00 GMT

An oral treatment of harmless, specially engineered gut bacteria was able to reverse type 1 diabetes (T1D) in experimental mice, according to a partially JDRF-funded study in Belgium. The findings, which were recently published in the April edition of the Journal of Clinical Investigation, may hold implications for future translation of the treatment to people with the disease, which has no known cause or cure.

The international, collaborative team, led by Chantal Mathieu, M.D. at Belgium’s KU Leuven and ActoGenix, a biopharmaceutical company, treated the mice with ActoBiotic therapy—genetically modified Lactococcus lactis—which secreted an autoantigen called proinsulin, and an immune-modulatory protein molecule called interleukin-10 (IL-10), an anti-inflammatory protein molecule with suppressive effects in preventing autoimmune disease. When combined with a low dose of an anti-CD3 antibody for five days, the therapy halted T1D progression in the newly-diagnosed, non-obese diabetic (NOD) mice. CD3 is a protein required for T-cell activation. T-cells are immune cells that are involved in the destruction of beta cells in the pancreas during the autoimmune process of T1D.

Three months of follow-up after the mice were given the ActoBiotic treatment showed that glucose levels in the mice remained stable. The investigators also reported that while there was no evidence the therapy triggered beta cell proliferation, it did seem to reactivate beta cells that were deactivated by the diabetes-related immune inflammation. The investigators suggested that this combination resulted in a resetting of the immune system toward a long-term tolerance of the body’s beta cells.

The KU Leuven study adds to our understanding of T1D, which is why JDRF is actively supporting research that allows us to better understand the process leading to the misguided immune attack on the beta cells and potential therapeutic interventions at each stage of this complex disease. In particular, JDRF is looking at ways to develop more specific therapies to promote tolerance of the beta cell antigens that trigger the autoimmune response, without generally weakening the immune system; such therapies are a critical component of a comprehensive therapeutic approach to T1D.

New Industry Partnership Paves the Way for Drug Development for Beta Cell Regeneration

Liz Cuebas — Wed, 18 Apr 2012 15:54:14 GMT

JDRF industry partner NGM Biopharmaceuticals, Inc., recently announced a new partnership with Daiichi Sankyo Company, Ltd., a Japanese pharmaceutical company. The partnership will focus on discovering and developing drugs to regenerate pancreatic beta cells and improve their function. Such therapies would represent a significant advance for people with type 1 diabetes (T1D) or type 2 diabetes (T2D). Beta cell regeneration is one of JDRF’s priority areas of research in T1D.

JDRF formed a partnership with NGM Biopharmaceuticals in September 2011. Prior to partnering with JDRF, NGM built a unique discovery platform and expertise that could enable the discovery of novel drugs to promote beta cell regeneration. JDRF’s collaboration with NGM aims to translate the company’s successes to the discovery of regenerative medicines to help people with T1D.

JDRF’s Industry Discovery and Development Partnership (IDDP) program exists to facilitate the creation of partnerships such as this one. Through the IDDP program, JDRF partners with biotechnology and pharmaceutical companies. These partnerships are crucial because they provide access to scientific and financial resources that enable JDRF-funded research to advance more quickly and efficiently. Industry involvement is a vital component of drug development and making new treatments available to people with T1D.

The announcement of the new partnership between NGM and Daiichi Sankyo represents a success story for JDRF’s IDDP program. The partnership will provide significant opportunities for scientific discoveries and clinical development of promising beta cell regenerative therapies for diabetes. Daiichi Sankyo will be primarily responsible for conducting trials and bringing any new treatments to market. JDRF is pleased that the NGM technology will be expanded by the partnership with Daiichi to advance beta cell regeneration research.

MRI Scanning Technique Predicts T1D Onset

Shana — Thu, 29 Mar 2012 14:38:00 GMT

In a recent study published in the current issue of Nature Immunology, a JDRF-funded team led by Dr. Diane Mathis from the Harvard Medical School and Massachusetts General Hospital developed a technique that uses MRI and nanoparticles for predicting type 1 diabetes (T1D).

In the study, which was conducted in mice, researchers injected two sets of mice – one with a genetic predisposition to T1D and one without – with magnetic nanoparticles designed to accumulate in inflamed tissues. The inflamed tissues are an indicator of the autoimmune attack that causes T1D. After scanning the mice using MRI, the researchers discovered increased inflammation in animals disposed to T1D starting from six to 10 weeks of age. According to the study’s author Dr. Wenxian Fu, this result shows that the progression of the disease, at least in this animal model, is determined very early in life. In the case of these mice, it seems T1D does not require an additional trigger such as a secondary infection or environmental stress.

In addition to discovering and predicting T1D onset in mice subjects, the researchers found other applications for the MRI imaging technique. They identified a number of previously unknown molecular and cellular elements that correlated with disease protection. One of these protective elements is CRIg, the complement receptor of the immunoglobulin superfamily. The presence of CRIg marked a subset of macrophages associated with diabetes resistance. The scientists injected CRIg engineered molecules into mice predisposed to diabetes and found that it resulted in a lower incidence of the disease.

Although these findings are promising, future studies will be necessary to determine the technique’s potential for discovering markers of T1D progression in humans and developing new drug therapies to prevent the disease. The findings open the possibility that imaging of inflammation in the pancreas will help identify individuals who will develop T1D and predict how rapidly the disease might progress. This result would be important for prevention trials as well as for studies aimed at preserving beta cell function. Furthermore, the ability of CRIg to prevent disease and reduce inflammation as determined by this imaging technique opens up the possibility for novel therapeutic approaches. The study is another step forward for JDRF’s research focus on discovering pathways to prevent T1D from occurring or stopping the autoimmune attack that causes the disease.

Novel technology may help new beta cells survive

Gary — Thu, 08 Mar 2012 15:41:14 GMT

Replacing the body’s insulin-producing beta cells is one potential method for curing type 1 diabetes (T1D). Researchers are attempting to solve a number of challenges to make beta cell replacement a reality. These include:

overcoming the misguided immune system attack on these cells that causes T1D in the first place (through strategies such as encapsulation) and the immune response to the foreign new beta cells,
identifying a source for new beta cells,
and ensuring that the new beta cells have the environment they need to survive, function, and ultimately produce insulin once they’re in the body.

In a new study published in the journal Proceedings of the National Academy of Science (PNAS), researchers from the Diabetes Research Institute (DRI) may have developed a solution to the final challenge. Beta cells need oxygen and other nutrients in order to survive and function. New beta cells introduced to the body lack a vascular network of blood vessels to deliver oxygen and other nutrients, which is a major impediment to their survival. To overcome this challenge, the DRI scientists developed a new biomaterial that generates oxygen and delivers it to newly implanted beta cells, allowing them to function until a vascular network develops. Since this initial study was conducted using a laboratory model, researchers will now seek to clinically apply the results. The goal is to use this technology as part of the encapsulation system of islets for transplantation in people with T1D.

The DRI researchers who conducted this study were funded by JDRF and the Helmsley Charitable Trust (HCT) as part of a collaboration to accelerate the pace of research and development to deliver better treatments, devices, and diagnostics for improving the lives of people with T1D. This study also illustrates the success of two JDRF research funding strategies in addition to the HCT collaboration. Dr. Camillo Ricordi, DRI’s scientific director, has been the recipient of a number of substantial JDRF funding grants. One of these grants specifically helped fund this and other DRI research related to beta cell replacement. Also, the study’s lead researcher, Dr. Cherie Stabler, is the past recipient of a postdoctoral fellowship from JDRF that enabled her to investigate methods for beta cell survival using her biomedical engineering background. JDRF provides postdoctoral fellowships to attract qualified, promising scientists in the early stages of their professional careers to the T1D research field with the long-term goal that, as independent investigators, they will contribute to research aimed at curing, treating, and preventing T1D.

Key Component of Artificial Pancreas Shown Successful in Reducing Hypoglycemia in People with T1D

Tara Wilcox-Ghanoonparvar — Thu, 23 Feb 2012 16:09:00 GMT

In a study published this month in Diabetes Technology & Therapeutics, researchers concluded that the automatic suspension of insulin delivery by a low glucose suspend (LGS) system greatly reduces the severity and duration of hypoglycemia (extreme low blood sugar) in people with type 1 diabetes (T1D). An LGS system is built into an insulin pump and halts insulin delivery when it detects low blood glucose levels from a continuous glucose monitor (CGM). When blood sugars are low, insulin delivery could increase the risk of hypoglycemia, which, if untreated, could lead to a multitude of complications, including lack of consciousness, coma, and even death. LGS systems are precursors to a fully automated closed-loop artificial pancreas, which could revolutionize the way of life and the health of people with T1D.

The study was conducted by Satish Garg, M.D., editor-in-chief of Diabetes Technology & Therapeutics and professor of pediatrics at the University of Colorado in Denver, along with colleagues from the Barbara Davis Center for Childhood Diabetes in Colorado; Rainier Clinical Research Center in Washington; and the AMCR Institute, Inc., Stanford University Medical Center, Mills-Peninsula Health Services, and Medtronic Inc. in California.

In the randomized cross-over trial, subjects with T1D fasted overnight and exercised to induce hypoglycemia. In random order, the LGS feature was turned on in some exercise sessions, and turned off in others. After comparing data from the successful sessions, researchers found that use of the LGS feature reduced the length and intensity of hypoglycemic episodes, without resulting in a rebound effect of hyperglycemia.

LGS systems would be key to the safety and effectiveness of an artificial pancreas— which would combine an insulin pump with a CGM, allowing the devices to "talk" to one another via sophisticated computer software—making this latest study a step forward for people with T1D.

JDRF is driven toward improving the lives of every person living with T1D, and toward preventing, treating, and curing the disease and its complications through the support of research. That is why the artificial pancreas is one of JDRF’s research priorities, and why we have been a leader in propelling its development and testing. Not only would an artificial pancreas allow people with T1D to take a break from their full-time jobs of managing their diabetes; studies have shown that blood glucose regulation improves with its use—particularly during sleeping hours, when the risk of hypoglycemia increases. A myriad of benefits continue to surface as research progresses, showing the potential of an artificial pancreas to vastly improve lives, and keep people with T1D safe.

The Food and Drug Administration (FDA) issued guidance for the testing of LGS systems in June 2011, and in December 2011, following strong advocacy efforts by JDRF and other supporters, the FDA issued its draft guidance for artificial pancreas systems. This guidance is needed to move research to the next stage of testing outside the hospital setting, in more real-life conditions. JDRF plans to submit its comments to the FDA on the draft AP guidance in March.

JDRF Part of a Growing Trend of Nonprofits Leading Drug Development

Michael — Thu, 16 Feb 2012 14:30:00 GMT

Nonprofit organizations focused on disease research are transforming their traditional roles, and emerging as key players in accelerating the development of better treatments and cures, according to a recent report by the Harvard Stem Cell Institute (HSCI) and the Multiple Myeloma Research Foundation (MMRF). The Harvard Business School convened a roundtable panel in 2011 that addressed the obstacles facing drug development today. JDRF was one of a handful of nonprofits—which also included the Michael J. Fox Foundation for Parkinson’s Research, the Cure Alzheimer’s Fund, and the Bill & Melinda Gates Foundation—who participated in the panel, and discussed how they are stepping in to bridge gaps between laboratory research and the commercialization of new products and treatments.

Despite many scientific advances, targeted treatments and cures for many complex diseases remain elusive. Therefore, drug development in areas like type 1 diabetes (T1D), Parkinson’s disease, or Alzheimer’s disease remains a challenge. In addition, regulatory hurdles can make the approval process for new drugs difficult, and more companies and venture capitalists are reluctant to invest in early stage research given the current economic environment. These are a few of the factors that are contributing to the changing landscape of drug development, which formed the basis of the roundtable conversations at Harvard.

The discussions from the panel were documented in HSCI and MMRF’s recently released white paper, “The Advancing Role of Non-Profit Organizations in Drug Development.” The paper outlines case studies, best practices, and the most effective new models that nonprofit organizations are using to accelerate research and development efforts leading to better treatments and cures for diseases. Like many other diseases, T1D is complex and remains a huge, unmet medical need. As the leading charitable organization focused on T1D research, JDRF continually looks at what has to happen to bring therapies to people faster, identify critical gaps and try to find innovative opportunities so that promising early stage research can progress to potential therapies.

To bridge these gaps, nonprofits like JDRF are assuming the role of a “trusted third party” and facilitating collaborations with industry and others to influence research strategy. In this unique role, nonprofits are not only providing financial support, but additional expertise on research plans and even regulatory guidance. Furthermore, strategic partnerships between nonprofits and industry help reduce the risk of early-stage research that is often considered “high risk” since the science is not yet proven or the return on investment uncertain. As a result, more companies are seeing a benefit to entering previously empty arenas, further helping to advance research toward better treatments and cures for diseases like T1D. JDRF’s industry partnerships program, developed in 2006, is an integral part of the organization’s overall strategy to accelerate better treatments and cures, supporting critical research that otherwise would not have advanced without JDRF’s involvement.

Of note, JDRF’s chief scientific officer, Dr. Richard Insel, highlighted JDRF’s collaboration with the Genomics Institute of the Novartis Research Foundations (GNF) as an example of innovative deal structures that nonprofits are creating to allow them to partner more meaningfully with innovators throughout the drug development pipeline. The GNF collaboration is part of JDRF’s industry partnerships program.

Dr. Insel pointed out that through funding basic academic research, JDRF had proven that it was possible to generate new pancreatic beta cells. But like the other nonprofits at the roundtable, JDRF discovered a gap between the research being performed at academic institutions and the products being developed for commercial use. By partnering with GNF, Novartis and GNF would undertake the responsibility for commercializing and developing beta cell regeneration products while JDRF would provide access to its significant academic networks and experience in the T1D space. Should GNF succeed in commercializing a product based on this research, JDRF would be entitled to a modest return on its investments.

JDRF’s partnership with GNF is just one example of how nonprofits are forming strategic alliances with industry to develop better treatments and cures, and accelerate the delivery of these advances to the marketplace.

Study Helps Explain Activity of Anti-CD3 in Treating or Preventing Type 1 Diabetes

Joana Casas — Mon, 06 Feb 2012 14:39:00 GMT

JDRF-funded scientists at Yale University recently found a mechanism of action by which teplizumab, an anti-CD3 antibody may be working as an immune therapy for T1D.

Currently, once T1D starts to develop, there’s no intervention developed to stop it. The immune system slowly and inevitably kills the pancreatic beta cells that produce insulin, a hormone that enables people to get energy from food. As a result, people with T1D have to test their blood sugar and give themselves insulin (with injections or an insulin pump) multiple times every day in order to stay alive. What’s more, reversing T1D remains an elusive and complicated challenge, requiring restoration of the insulin-producing cells that were destroyed, as well as solutions to turn off the misguided immune system attack on insulin-producing cells.

Teplizumab, the drug used in the study, is thought to work by shutting off a part of the immune system most responsible for attacking these insulin-producing cells and generating long-term immunoregulation to control this misguided autoimmune response. While previous trials tested whether teplizumab might preserve insulin production in people recently diagnosed with T1D, researchers are now also studying whether the drug might preemptively prevent or delay the development of T1D in at-risk individuals. One such study is being conducted by the National Institutes of Health’s Type 1 Diabetes TrialNet.

The latest findings about teplizumab are reported in the current issue of the journal Science Translational Medicine. In the study, which was funded by JDRF, NIH, Yale University, and the Health Service Executive of Ireland, researchers led by Dr. Kevan Herold, M.D., professor of immunobiology at Yale School of Medicine used a mouse model with a functional human immune system, and focused on the effect of the drug on T cells, a critical immune system component involved in the development of T1D. The team found that the drug induced certain T cells to migrate from the circulatory and lymph systems to the small intestine, where they produced the immunoregulatory protein interleukin-10 (IL-10). IL-10 is an important regulator of the immune system that has a role in preventing or controlling autoimmune diseases. These T cells were also converted into regulatory T-cells, known to be helpful in restoring and maintaining normal immune system balance.

While researchers have yet to fully understand teplizumab’s potential role in treatment or prevention of T1D, this study underscores the importance of understanding the mechanism of action of therapies in translational research – the ability to effectively convert lab findings into useful therapies in clinical studies. The work provided important clues about how the investigational drug works in human cells and demonstrated that humanized mice can be successfully used to identify how drugs such as this one work in people.

By better understanding a therapy’s exact mechanism of action, it allows researchers to improve the design of future trials, including developing biomarkers to determine dosing and assess efficacy. In this case, the Yale study unlocks doors for more studies to explore the extent to which therapies that target the immune system may prevent the onset of T1D.

New study may help determine risk of kidney disease for people with diabetes

Gary — Mon, 30 Jan 2012 19:16:04 GMT

Nearly 20 years ago, the Diabetes Control and Complications Trial (DCCT) proved that keeping tight control over blood sugar levels can help prevent or delay the onset of complications for people with diabetes. Since then, researchers have continued to study complications with the goal of discovering how to predict, prevent, and reverse them on an individual level.

The results of two studies reported in the Journal of the American Society of Nephrology may for the first time allow doctors to accurately determine an individual’s risk for developing diabetic kidney disease, and ultimately kidney failure. In the studies, researchers identified two proteins, TNFR1 and TNFR2, whose presence was strongly associated with the development of severe kidney complications in people with type 1 and type 2 diabetes. The studies both followed people with diabetes over a number of years and found that those with higher concentrations of these two proteins were at the greatest risk for kidney disease, regardless of any other factors. They also found that the presence of the proteins could predict the progression of kidney disease, as people with higher concentrations experienced a more rapid decline in kidney function. JDRF provided part of the funding for the studies.

The findings from this research could benefit people with diabetes both in the near future and in the long term. The most immediate impact may be the development of new diagnostic tests that measure TNFR1 and TNFR2 and can predict who is at the highest risk of developing diabetic kidney disease. No such tests are currently available. In the long term, the findings contribute to our knowledge of how diabetic kidney disease develops and can inform efforts to prevent or reverse it.

JDRF continues to fund this and other research with the goal of preventing and reversing the complications of diabetes.

JDRF-Funded Project Identifies Cell that Triggers T1D

Liz Cuebas — Mon, 23 Jan 2012 17:45:47 GMT

JDRF-funded researchers at the La Jolla Institute of Allergy and Immunology in San Diego have become the first researchers to successfully determine which kind of T-cells are responsible for the autoimmune attack on the insulin-producing beta cells in people with type 1 diabetes (T1D). (T-cells are white blood cells that take a central role in the body’s immune system.) The study appeared in a recent issue of the Journal of Experimental Medicine.

Utilizing the resources of JDRF’s Network for Pancreatic Organ Donors with Diabetes (nPOD), Matthias Von Herrath, M.D., and his research team examined pancreatic tissue from organ donors who had T1D. Dr. Von Herrath’s group of scientists discovered the presence of a specific type of T-cell, CD-8, which reacts to beta cells in pancreatic islets. They also determined which areas of the islets were most vulnerable during the autoimmune attack. Dr. Ken Coppieters, one of the study’s co-authors, explains: “Knowing which pieces of the molecules the T cells react against is a crucial prerequisite to design therapies that attempt to restore balance within the immune system.”

nPOD is an innovative JDRF-funded project that is based at the University of Florida, Gainesville that provides donated organs from people with T1D to leading diabetes scientists all over the world for use in their research studies. It provides researchers with a unique opportunity to literally see and better understand the initial steps of T1D and its physiological impact on the pancreas and immune system. According to Dr. Von Herrath, the chance to study human pancreatic tissue was crucial to the study’s success: "The use of this tissue from the nPOD consortium was critical to our ability to prove which T cells are most important in destroying beta cells in humans, which leads to type 1 diabetes, and where these cells are located in the pancreas."

JDRF is equally excited that nPOD provided significant support for Dr. Von Herrath’s research team. JDRF’s Director of the Immune Therapies program, Teodora Staeva, Ph.D., says, “We are certainly pleased that nPOD enabled this study through the supply of human tissue. It is a perfect example of the kind of cutting-edge research that JDRF is proud to support to catalyze major research advances in type 1 diabetes.”

JDRF is hopeful that this discovery will help scientists develop methods of stopping or reversing the autoimmune process, which will be a key component of delivering a T1D cure. Additionally, we look forward to continuing opportunities for nPOD to serve as a resource to T1D research teams around the world.

Study on Economic Impact of Diabetes doesn’t Distinguish between T1D and T2D

Shana — Tue, 17 Jan 2012 17:31:00 GMT

One of the common frustrations for people with diabetes is the lack of understanding about the difference between type 1 diabetes (T1D) and type 2 diabetes (T2D). T1D is an autoimmune disease which affects as many as 3 million Americans, is not caused by diet or lifestyle, and cannot be prevented. T2D, on the other hand, is a metabolic disorder that affects more than 18 million Americans, and may be associated with obesity or a sedentary lifestyle.

A recent study conducted by researchers from the Yale School of Public Health suggests diabetes could affect education and earning potential for young people with the disease. The study, published in the journal Health Affairs did not distinguish between subjects with T1D and T2D. Since there are differences between T1D and T2D and the populations they affect, it is unclear whether the economic impact identified in the study would be the same for T1D and T2D. By not differentiating between the two, the study may also create misconceptions about people with T1D. Comments on articles reporting on the study display the frustration of the T1D community.

In the study, researchers followed 15,000 people from high school through their early 30s during a fourteen year period and identified a number of disparities in educational and financial achievement. These disparities include a higher high school dropout and unemployment rate for people with diabetes, as well as a lower lifetime earning potential as compared to people without the disease. Since these findings are preliminary and do not differentiate between T1D and T2D, further studies would be needed to determine whether people with T1D are at a true economic disadvantage.

JDRF places a strong emphasis on correcting T1D misconceptions and supports people with T1D in coping with the physical and emotional aspects of the disease at the same time as dealing with daily living issues such as school and employment. Although the disease presents obstacles, people and families with T1D continue to provide inspiration by facing the daily challenges associated with the disease and not letting it stand in the way of obtaining their career, educational and personal goals.

A look back on recent research progress as 2012 draws near

Tara Wilcox-Ghanoonparvar — Wed, 21 Dec 2011 17:22:13 GMT

As we inch toward the end of 2011, a look back over the past few months shows a great deal of progress in JDRF’s efforts toward curing, treating, and preventing type 1 diabetes (T1D) and its complications. Check out the latest key advances from the first quarter of fiscal year 2012 (July through September 2011) in the “Research” section of jdrf.org by clicking on each of the “Cure,” “Treat,” and “Prevent” areas and scrolling to the bottom of each page for a breakdown of progress throughout the months; progress we regularly update to keep you abreast of the latest developments in the fight against T1D.

Part of JDRF’s efforts to cure T1D is through its support of research to better understand the process that leads to the misguided immune attack on beta cells, and to discover potential therapies to intervene at every stage of the disease. Read the latest in immune research here. Another area within JDRF’s efforts to cure T1D is focused on developing drugs that could regenerate beta cells, potentially restoring their function in people with T1D. For the latest in regeneration research, click here. The third area of focus toward curing T1D is the replacement of beta cells. This is possible through either whole pancreas or islet transplantation. Yet transplantation comes with its obstacles, given the lack of sufficient donors and the need for chronic immunosuppression, which comes with significant side effects. Replacement research explores potential solutions to these obstacles, such as encapsulation (shielding beta cells from attack) and beta cell imaging. Read about the latest developments in replacement research here.

JDRF is also working toward treating T1D and its complications, to improve the lives and health of people at every age and every stage of the disease. One main focus has been the development of an artificial pancreas—a device that would combine a continuous glucose monitor and an insulin pump, which could help to improve blood sugar control and even save lives. The past few months have yielded many key advancements in artificial pancreas development; read about them here. Glucose control therapy research is another main area within efforts to treat T1D. The development of ultra-fast insulin and insulin that responds to glucose levels (glucose-responsive insulin), the improvement of insulin delivery, exploration of the role of hormones in controlling glucose levels, and other novel therapies comprise this important area of research. Read the latest advancements in glucose control therapy research here. Complications of T1D are a major concern to people with the disease, which is why JDRF’s complications prevention research is another main area within efforts to treat T1D. Diabetic eye disease, one of the many devastating complications that can arise in someone with T1D, is another focus that has seen advancements over the past few months. Read about the latest efforts to target those people most at risk for developing diabetic eye disease, and where research has brought us today.

The third key area of research that JDRF supports is aimed at discovering possible ways to prevent T1D. Prevention would represent a cure for people identified as at risk for developing T1D, and could have a significant impact on the increasing incidence of the disease. Recent studies have increased our understanding of how T1D develops, have improved our ability to screen for the risk of developing T1D, and are paving the way toward developing therapeutic interventions to preserve residual beta cell function in recent onset T1D, and now in people identified as at risk. Read about the latest in prevention research here.

As we make our way into the new year, JDRF is encouraged by developments from recent months in the areas of curing, treating, and preventing T1D, and we are excited to continue to share with you the latest in research progress. We hope you continue to stay tuned and informed!

Diabetes in Action: New visualization technique allows researchers to see the destruction of insulin-producing beta cells

Michael — Thu, 08 Dec 2011 15:54:07 GMT

Last week, JDRF-funded researchers from the La Jolla Institute for Allergy and Immunology in San Diego, California announced that they had created the first 3-dimensional movies depicting the destruction of insulin-producing beta cells – the process that ultimately leads to type 1 diabetes (T1D) – in real-time mouse models. Their research was published in this month’s Journal of Clinical Investigation.

So much of T1D goes unseen by patient and physician alike. A patient often is not even diagnosed until the disease progression has reached a point that can be potentially dangerous. Even the researchers tasked with studying the disease and its cause(s) have done so largely by observing the effects of the disease – the symptoms from the overall reduction in the beta cell population – instead of being able to actually see the beta cells as they are destroyed.

The basis for the new imaging is a two-photon microscope and a new technique developed by JDRF Scholar, Dr. Matthias von Herrath to access the pancreas. The JDRF Scholar program was initiated in 2006 to support pioneering, potentially breakthrough research. Using intense light pulses, the microscope is able to visualize the cells of the pancreas as well as the blood vessels being used by immune T cells to access the pancreas. These blood vessels are important as they are allowing the immune T cells to enter the pancreas where they would not normally exist.

Researchers are already benefiting from these movies, gaining a better understanding of the process and speed with which the beta cells are destroyed by the immune cells. By watching in real time, the researchers observed that the process of beta cell death happened much slower than previously believed, requiring tens of millions of T cells to destroy a significant number of beta cells. This finding provides a potential explanation for the relatively long preclinical stage of the disease.

This breakthrough at the La Jolla Institute for Allergy and Immunology gives T1D researchers an important tool for studying the disease in its earliest stages in hopes of better understanding how the disease unfolds. Thanks to the high level of detail provided by the videos, researchers have noted specific cellular interactions and behaviors from which they hope to develop a way to halt or prevent the disease process.

Progress on the Artificial Pancreas

Jeffrey Brewer — Tue, 06 Dec 2011 19:38:37 GMT

I’m pleased to share the news that on Thursday, December 1, the U.S. Food and Drug Administration (FDA) issued artificial pancreas (AP) draft guidance. While the draft guidance is still under review, our initial analysis suggests that it affirmatively addresses many of JDRF’s key issues, and, in so doing, it appears to lay a foundation for accelerating the development and availability of AP technologies that will improve the lives of millions of Americans living with type 1 diabetes (T1D).

But there is more to the story. The fact is that this encouraging outcome probably would not have happened without the contributions of JDRF, our community, and our allies. In fact, it is fair to say that without JDRF, there might not have been any guidance at all, or at least not in 2011. And that is a good place to start the story.

By 2010, it was clear that JDRF-funded research in academic, hospital settings showed that prototype AP systems could greatly improve glucose control, and with encouragement from JDRF, companies had committed to developing commercial products for people with T1D. But there was no defined regulatory pathway for AP outpatient studies or product review, nor were there any immediate plans for the FDA to develop these clinical guidelines, which threatened to greatly slow the research and development process. So JDRF decided to play a leadership role to short-circuit potential bureaucratic delays, and to ensure that the FDA had the most current, state-of-the-art scientific thinking on the AP.

In July 2010, JDRF convened a panel of leading clinicians and researchers to make recommendations to the FDA about the key clinical questions for AP studies, which were presented at a public meeting that November. In early 2011, JDRF incorporated those recommendations into a guidance document that we proposed to the FDA. At the same time, we intensified our efforts by making issuance of AP guidelines a key “ask” of the advocates at our annual Government Day in March. Their efforts, and the efforts of countless JDRF volunteers across the country, resulted in more than 250 House members and more than 60 U.S. senators sending letters to the FDA calling on the agency to produce timely AP guidance that takes into account the recommendations of leading experts. In these highly partisan times, securing such broad bipartisan support for this goal was truly remarkable.

We continued our efforts at Children’s Congress in June, where, at a Senate hearing on June 22, the FDA committed to releasing AP draft guidance by December 1. It soon became apparent that simply seeing the FDA issue guidance would not be enough. Indeed, when the FDA released unreasonable, highly problematic low-glucose suspend (LGS) system guidance—guidance covering a system that was already available and in use in more than 40 countries around the world—JDRF’s team recognized the very real risk that the AP guidance might be similarly flawed, setting back the development of AP systems by years.

Once again, we mobilized and increased our efforts. JDRF chancellor Pam Sagan testified at a House hearing on medical device regulation on July 20, when she highlighted the need for timely access to innovative, life-saving technologies to help better manage diabetes, citing LGS systems as a key example. In August, we launched our Promise to Remember Me Campaign, in which our volunteers held 250 meetings with members of Congress in communities across the country by the end of November to enlist them to encourage FDA action.

After Labor Day, we began a more intense campaign to encourage the FDA to not only issue AP guidelines by December 1, but to issue guidelines that, unlike the LGS ones, would not throw up unnecessary obstacles to the development of these systems. Of course, the centerpiece of these efforts was substantive, solutions-oriented engagement with the FDA’s scientific and device center teams. To their credit, members of the FDA staff not only were open to dialogue with JDRF’s AP team and the clinical community, they genuinely listened to our concerns.

Beyond this interaction with the FDA, some of our activities were visible, such as the letter from leading diabetes clinical organizations (AACE, ADA, AADE, Endocrine Society), the powerful full-page newspaper ads in The New York Times and The Washington Post, and the Capitol Hill press conference; and others were less visible, such as our ongoing outreach to key Congressional supporters, who directly communicated to the FDA how important it was to get the AP guidance right. Then there was our online petition, which so many of you signed, a petition that was eventually delivered to the FDA with more than 100,000 signatures gathered in five weeks’ time.

Which brings us back to Thursday’s announcement by the FDA.

The AP draft guidance clearly indicates that the FDA has worked hard to produce reasonable guidelines for artificial pancreas systems. The guidance appears to provide a rapid timetable to move from inpatient trials to outpatient trials, and its flexible requirements allow for clinical development in a manner that will advance AP trials while ensuring their safety and effectiveness. For this, the FDA deserves great credit. Furthermore, this draft guidance suggests that Commissioner Margaret Hamburg and the FDA are committed to fostering innovation and being a global leader in bringing life-saving technologies for people with T1D to the U.S. market.

We are still studying the details of this highly technical, 60+-page draft guidance. We know there will be issues and further considerations that we will want to address; we know there will be more dialogue with the FDA before final guidance is completed. But we also know that without the involvement of the clinical community; without the contributions of so many of our volunteers who testified, wrote op-eds and letters to the editor, signed petitions, and more; without the commitment of our Hill allies such as Diabetes Caucus co-chairs Susan Collins, Jeanne Shaheen, Diana DeGette, and Ed Whitfield; without the outpouring of signers to the petition; without our successful efforts to raise the profile of this issue in the FDA, the Congress, the White House, and the T1D community; without a regulatory agency with committed professionals pushing forward an innovative agenda; and without the extraordinary commitment and cooperation of so many JDRF staffers and departments, we would not be as close as we are to seeing this revolutionary technology reach the hands of people with T1D.

Thank you for your continued dedication.