In related discoveries with far-reaching implications for treating diabetes and understanding hypertension, University of
Utah researchers have learned why thiazolidinediones (TZDs), a major anti-diabetes drug, cause edema and also have found a
new pathway critical to fluid metabolism. Identification of this pathway may help understand fundamental mechanisms of blood
pressure control.
Using knockout-gene technology, the U of U School of Medicine researchers found that when TZD activates a nuclear receptor,
the peroxisome proliferator-activated receptor gamma, in the collecting duct in the kidney, it serves as a mechanism for
fluid retention, or edema. The researchers suggest that the distal nephron, for example the collecting duct, is crucial for
regulation of sodium balance and blood pressure. The research is published this week in the Proceedings of the National
Academy of Sciences online.
The discoveries may point the way to developing different drugs to treat Type II diabetes and open an entirely new area in
the study of hypertension, according to Tianxin Yang, M.D., Ph.D., the two-year study's principal investigator, associate
professor of internal medicine at the U medical school, and staff physician at the George E. Wahler Veterans Affairs Medical
Center in Salt Lake City.
An estimated 18 million Americans suffer from diabetes. TZD compounds have been shown to be highly effective in lowering
blood glucose and lipid levels and in controlling blood pressure.
"It's almost a perfect drug for diabetes," Yang said.
But many diabetics who use TZD eventually have to discontinue the drug because it causes edema. About 1 percent of people who
take TZD get pulmonary edema and chronic heart failure, both being potentially life-threatening conditions.
TZD works by activating PPAR-gamma, a receptor that helps sensitize the body to insulin. PPAR is found in muscle, fat,
kidney, and heart and controls fatty acid and lipid metabolism. In the kidney, PPAR is found in the collecting duct, a
critical site for the control of fluid metabolism.
To test the role of PPAR in edema, Yang created mice that specifically lacked PPAR-gamma in the collecting duct. He then
administered TZD to these mice, as well as to a control group that didn't lack PPAR-gamma.
The mice not lacking PPAR-gamma showed about a 10 percent average increase in body weight because of fluid retention. The
blood plasma volume of these mice increased by one-third, Yang said. But the mice bred without PPAR-gamma experienced no
increase in body weight in response to the drug, according to Yang.
"This tells us that the body weight gain is regulated by PPAR-gamma in the collecting duct," he said. "We also found this
drug decreased the sodium excretion in urine, so this could explain the fluid retention."
The mice without PPAR in the collecting ducts incurred no changes in sodium reabsorption, while those with PPAR excreted less
sodium through urination. Yang said that the distal nephron, which is usually subject to hormone regulation in the kidney,
serves as a key pathway for keeping an accurate amount of sodium in the body.
Hypertension affects one in four U.S. adults and long had been considered a cardiovascular disease. But research now also
focuses on the kidneys and the role of the distal nephron in retaining sodium opens a new area for study, he said.
University of Utah Health Sciences Center
50 N. Medical Dr.
Salt Lake City, UT 84132
United States
hsc.utah/uuhsc/news
суббота, 14 мая 2011 г.
Wound Management Technologies Expands Distribution Foot Print In Florida With The Addition Of Central Medical Systems
Wound Management Technologies, Inc. (OTC Bulletin Board: WNDM) announced that its subsidiary Wound Care Innovations, LLC has further expanded its rapidly growing coverage of the Florida wound care market with the addition of Central Medical Systems to its already extensive list of distributors and suppliers. "A company like CMSI is the ideal type of distributor; they have credibility and an established history in the market and understand the business of wound care especially for diabetic patients. I look forward to a very fruitful relationship," stated Ron Mathis, Sr. VP of Marketing and Sales for Wound Care Innovations, LLC.
Trent Harley, President of Central Medical Systems was quoted as saying, "We are excited to be a new distributor for Cellerate RX®. Over the past year, CMSI has observed the demand for Cellerate RX® outpacing the growth of other collagen-based wound care products being sold in the Florida market."
Central Medical Systems of Winter Park, Florida is a full service medical supply company, serving the wound care professional, and patients in need of wound care or diabetic supplies.
Safe Harbor Statement:
The statements in the press release that relate to the company's expectations with regard to the future impact on the company's results from new products in development and any other statements not constituting historical facts are "forward-looking statements," within the meaning of and subject to the safe harbor created by the Private Securities Litigation Reform Act of 1995. Since this information may contain statements that involve risk and uncertainties and are subject to change at any time, the company's actual results may differ materially from expected results. This document may contain forward-looking statements concerning the Company's operations, current and future performance and financial condition. These items involve risks, contingencies and uncertainties such as product demand, market and customer acceptance, the effect of economic conditions, competition, pricing, the ability to consummate and integrate acquisitions, and other risks, contingencies and uncertainties detailed in the Company's SEC filings, which could cause the company's actual operating results, performance or business plans or prospects to differ materially from those expressed in, or implied by these statements. The Company undertakes no obligation to revise any of these statements to reflect the future circumstances or the occurrence of unanticipated events.
Trent Harley, President of Central Medical Systems was quoted as saying, "We are excited to be a new distributor for Cellerate RX®. Over the past year, CMSI has observed the demand for Cellerate RX® outpacing the growth of other collagen-based wound care products being sold in the Florida market."
Central Medical Systems of Winter Park, Florida is a full service medical supply company, serving the wound care professional, and patients in need of wound care or diabetic supplies.
Safe Harbor Statement:
The statements in the press release that relate to the company's expectations with regard to the future impact on the company's results from new products in development and any other statements not constituting historical facts are "forward-looking statements," within the meaning of and subject to the safe harbor created by the Private Securities Litigation Reform Act of 1995. Since this information may contain statements that involve risk and uncertainties and are subject to change at any time, the company's actual results may differ materially from expected results. This document may contain forward-looking statements concerning the Company's operations, current and future performance and financial condition. These items involve risks, contingencies and uncertainties such as product demand, market and customer acceptance, the effect of economic conditions, competition, pricing, the ability to consummate and integrate acquisitions, and other risks, contingencies and uncertainties detailed in the Company's SEC filings, which could cause the company's actual operating results, performance or business plans or prospects to differ materially from those expressed in, or implied by these statements. The Company undertakes no obligation to revise any of these statements to reflect the future circumstances or the occurrence of unanticipated events.
Taking Control Of Your Diabetes Conference Returns To Raleigh To Bring Answers, Advocacy And Hope For People With Diabetes
Taking Control of Your Diabetes (TCOYD) conference and health fair will be held May 2, 2009 at the Raleigh Convention Center, bringing national and local medical experts in diabetes care to people with all types of diabetes, those at risk for diabetes, and their loved ones for a day of highly informative and motivational programs.
Leading specialists will discuss practical advice and developments in the treatment of diabetes, the complications of the disease, psychological barriers to controlling diabetes, prevention, nutritional issues, heart disease and much more. The Taking Control of Your Diabetes conference is a collaborative effort of health professionals from major institutions and clinics including the University of North Carolina Health Care, Duke University Medicine, and Raleigh Endocrine Associates. The American Diabetes Association and North Carolina Diabetes Prevention and Control, among many other agencies and organizations, have partnered with TCOYD to present the 8th Taking Control of Your Diabetes event in Raleigh.
TCOYD participants can hear lectures, participate in screenings, and speak one-on-one with diabetes specialists including physicians, pharmacists, dietitians, certified diabetes educators, dentists, ophthalmologists and podiatrists.
A health fair with 40 informational exhibits from national and local diabetes-related companies and organizations will be open throughout the day. A banquet lunch is included and will feature special guest speaker Urban Miyares, blinded Vietnam veteran. Presumed dead following an ambush on his platoon, Miyares was found in a diabetic coma in a body bag, and subsequently diagnosed with diabetes. Miyares has succeeded in his life and career as an entrepreneur, motivational speaker, mentor, television and film personality, and world-class athlete.
"Diabetes is demanding and people's daily decisions have an immediate impact on their health. At the same time, information about living with diabetes is complex. Education is critical to staying on top of this disease. We are delighted to have TCOYD back in Raleigh," said endocrinologist and Conference Co-Director John Buse, MD.
There will also be a post-conference Meet & Greet from 5 to 6:00 p.m. for women with diabetes, co-hosted by TCOYD and Diabetes Sisters.
TCOYD founder and director Steven Edelman, MD, an internationally recognized leader in diabetes treatment, research and education, who has lived with diabetes for 37 years, says, "One of the biggest differences between diabetes and other diseases is that diabetes control is in the hands of the patients, not the doctors. This TCOYD conference will give people an edge on the information and empowerment they need to live well with diabetes."
TCOYD is a California-based 501c3 diabetes education organization. This is the 105th in the national series of conferences that the not-for-profit has presented since 1995. 2,000 participants are expected at this one-of-a-kind event.
Leading specialists will discuss practical advice and developments in the treatment of diabetes, the complications of the disease, psychological barriers to controlling diabetes, prevention, nutritional issues, heart disease and much more. The Taking Control of Your Diabetes conference is a collaborative effort of health professionals from major institutions and clinics including the University of North Carolina Health Care, Duke University Medicine, and Raleigh Endocrine Associates. The American Diabetes Association and North Carolina Diabetes Prevention and Control, among many other agencies and organizations, have partnered with TCOYD to present the 8th Taking Control of Your Diabetes event in Raleigh.
TCOYD participants can hear lectures, participate in screenings, and speak one-on-one with diabetes specialists including physicians, pharmacists, dietitians, certified diabetes educators, dentists, ophthalmologists and podiatrists.
A health fair with 40 informational exhibits from national and local diabetes-related companies and organizations will be open throughout the day. A banquet lunch is included and will feature special guest speaker Urban Miyares, blinded Vietnam veteran. Presumed dead following an ambush on his platoon, Miyares was found in a diabetic coma in a body bag, and subsequently diagnosed with diabetes. Miyares has succeeded in his life and career as an entrepreneur, motivational speaker, mentor, television and film personality, and world-class athlete.
"Diabetes is demanding and people's daily decisions have an immediate impact on their health. At the same time, information about living with diabetes is complex. Education is critical to staying on top of this disease. We are delighted to have TCOYD back in Raleigh," said endocrinologist and Conference Co-Director John Buse, MD.
There will also be a post-conference Meet & Greet from 5 to 6:00 p.m. for women with diabetes, co-hosted by TCOYD and Diabetes Sisters.
TCOYD founder and director Steven Edelman, MD, an internationally recognized leader in diabetes treatment, research and education, who has lived with diabetes for 37 years, says, "One of the biggest differences between diabetes and other diseases is that diabetes control is in the hands of the patients, not the doctors. This TCOYD conference will give people an edge on the information and empowerment they need to live well with diabetes."
TCOYD is a California-based 501c3 diabetes education organization. This is the 105th in the national series of conferences that the not-for-profit has presented since 1995. 2,000 participants are expected at this one-of-a-kind event.
American Society Of Hypertension Updates Guidelines To Address 7-Fold Mortality Increase In Hypertensive Patients With Diabetes
Updated guidance published in the current issue of the American Society of Hypertension's (ASH) Journal of Clinical Hypertension addresses the urgent need for physicians to take a more integrated, individualized approach to treating hypertension (high blood pressure) in patients with diabetes by treating the intricacies of each patient profile, rather than focusing on the disease in isolation. Early initiation of medications that block the renin angiotension system (ACE inhibitors or ARBs) coupled with either thiazide-like diuretics or calcium antagonists are needed to maintain BP
"Diabetes is a complex disease in which blood pressure control is imperative, but it requires more than blood pressure control alone to be most effective," explained Henry Black, MD, president of the American Society of Hypertension. "Our medical organization is providing physicians with more up-to-date guidance on how to assess and treat hypertensive patients with diabetes and we are saying 'act globally' to improve cardiovascular health."
Current guidelines advise that patients start on a combination antihypertensive therapy, ideally in a single pill to improve patient adherence, if blood pressure is greater than 20/10 mmHg above recommended target levels. ASH's new guidance reinforces this concept and provides specific data demonstrating how to initiate treatment and follow up with patients to achieve target blood pressure goals.
About the American Society of Hypertension
The American Society of Hypertension (ASH) is the largest U.S. organization devoted exclusively to hypertension and related cardiovascular diseases. ASH is committed to alerting physicians, allied health professionals and the public about new medical options, facts, research findings and treatment choices designed to reduce the risk of cardiovascular disease. For more information, please visit ash-us.
The authors of The Journal of Clinical Hypertension Position Paper were George L. Bakris, MD and James R. Sowers, MD, on behalf of the Hypertension Writing Group.
About The Journal of Clinical Hypertension
The Journal of Clinical Hypertension (JCH), published by Wiley-Blackwell provides unbiased, peer-reviewed, clinically relevant information to a wide audience of practicing physicians treating hypertension and cardiovascular disease. It is distributed monthly to approximately 40,000 physicians in the United States, including cardiologists, family practitioners and internists, with the primary objective of bridging the "knowledge-practice gap" between researchers and practicing clinicians. The Journal of Clinical Hypertension became an official journal of the American Society of Hypertension in 2005 and is listed in the National Library of Medicine's Index Medicus.
American Society of Hypertension (ASH)
148 Madison Ave., 5th Fl.
New York, NY 10016
United States
ash-us
"Diabetes is a complex disease in which blood pressure control is imperative, but it requires more than blood pressure control alone to be most effective," explained Henry Black, MD, president of the American Society of Hypertension. "Our medical organization is providing physicians with more up-to-date guidance on how to assess and treat hypertensive patients with diabetes and we are saying 'act globally' to improve cardiovascular health."
Current guidelines advise that patients start on a combination antihypertensive therapy, ideally in a single pill to improve patient adherence, if blood pressure is greater than 20/10 mmHg above recommended target levels. ASH's new guidance reinforces this concept and provides specific data demonstrating how to initiate treatment and follow up with patients to achieve target blood pressure goals.
About the American Society of Hypertension
The American Society of Hypertension (ASH) is the largest U.S. organization devoted exclusively to hypertension and related cardiovascular diseases. ASH is committed to alerting physicians, allied health professionals and the public about new medical options, facts, research findings and treatment choices designed to reduce the risk of cardiovascular disease. For more information, please visit ash-us.
The authors of The Journal of Clinical Hypertension Position Paper were George L. Bakris, MD and James R. Sowers, MD, on behalf of the Hypertension Writing Group.
About The Journal of Clinical Hypertension
The Journal of Clinical Hypertension (JCH), published by Wiley-Blackwell provides unbiased, peer-reviewed, clinically relevant information to a wide audience of practicing physicians treating hypertension and cardiovascular disease. It is distributed monthly to approximately 40,000 physicians in the United States, including cardiologists, family practitioners and internists, with the primary objective of bridging the "knowledge-practice gap" between researchers and practicing clinicians. The Journal of Clinical Hypertension became an official journal of the American Society of Hypertension in 2005 and is listed in the National Library of Medicine's Index Medicus.
American Society of Hypertension (ASH)
148 Madison Ave., 5th Fl.
New York, NY 10016
United States
ash-us
How Mobile Technology Can Help Patients Manage Diabetes
The McKesson Foundation has announced the six recipients of $1.3 million in research grants as part of its Mobilizing for Healthsm initiative to improve the health of underserved populations with chronic diseases through the use of mobile-phone technology. The Mobilizing for Healthsm grants, of up to $250,000 each, will support studies on diabetes care and management at six esteemed U.S. institutions. The Mobilizing for Health grant program dedicates $1.5 million annually to research grants and field-building activities, such as mobile health conference support and other mHealth field building activities.
Mobile health, or "mHealth," is a term used for the practice of medicine that relies on wireless devices, such as mobile phones, PDAs and remote monitoring devices, to improve patient care.
The studies will examine a range of mobile-health technology options from sending simple SMS text messages to patients to remind them to take their medications to a comprehensive mobile phone-based software program that is integrated with patients' electronic medical records. Each study will be completed within one year, several will test bilingual (Spanish and English) messaging strategies, and all are designed around patient populations served by community health clinics.
"These studies are part of an ongoing Foundation effort to tie innovative technologies to low-cost, scalable health solutions in order to better help patients manage their chronic conditions," noted Carrie Varoquiers, president of the McKesson Foundation. "Through initiatives like Mobilizing for Healthsm, the McKesson Foundation is committed to increasing access to affordable, high-quality healthcare for all."
The first cycle of Mobilizing for Healthsm grant recipients are:
Joshua Cohen, M.D., and Neal Sikka, M.D., of George Washington University
SMS messaging to reduce emergency department visits for people with diabetes
Samir Patel M.D., of George Washington University
Enhancing diabetes and hypertension self-management: A randomized trial of a mobile phone strategy
Lawrence Cheskin, M.D., FACP, of Johns Hopkins Bloomberg School of Health
Tailored Rapid Interactive Mobile Messaging (TRIMM) for weight control among the underserved
Kevin Clauson, Pharm.D., of Nova Southeastern University
Pilot study to assess the impact of SMS/text messages on medication adherence for Type 2 diabetes
David Lindeman, MSW, Ph.D., of the Public Health Institute
Patient-centered mHealth: New horizons in diabetes care at Family Health Centers of San Diego
Sanjay Arora, M.D., Michael Menchine, M.D., and Anne Peters, M.D., at the University of Southern California
Improving diabetes care for low-income Latino patients in the Los Angeles County healthcare system
The Impact of Diabetes
Diabetes poses a serious and growing health risk in the United States. According to the American Diabetes Association:
25.8 million American children and adults have diabetes (8.3% of the population) 79 million people in the United States have pre-diabetes
$174 billion was spent in the United States in 2007 on direct medical costs and indirect costs, such as work loss and premature mortality
Minority populations disproportionately suffer from diabetes and diabetes-related complications
The McKesson Foundation pledged to put diabetes management at the forefront of its Mobilizing for Healthsm grant program when it launched the initiative in April 2010, and will continue to focus its funding priorities on diabetes management and research through March 2012.
Mobile health, or "mHealth," is a term used for the practice of medicine that relies on wireless devices, such as mobile phones, PDAs and remote monitoring devices, to improve patient care.
The studies will examine a range of mobile-health technology options from sending simple SMS text messages to patients to remind them to take their medications to a comprehensive mobile phone-based software program that is integrated with patients' electronic medical records. Each study will be completed within one year, several will test bilingual (Spanish and English) messaging strategies, and all are designed around patient populations served by community health clinics.
"These studies are part of an ongoing Foundation effort to tie innovative technologies to low-cost, scalable health solutions in order to better help patients manage their chronic conditions," noted Carrie Varoquiers, president of the McKesson Foundation. "Through initiatives like Mobilizing for Healthsm, the McKesson Foundation is committed to increasing access to affordable, high-quality healthcare for all."
The first cycle of Mobilizing for Healthsm grant recipients are:
Joshua Cohen, M.D., and Neal Sikka, M.D., of George Washington University
SMS messaging to reduce emergency department visits for people with diabetes
Samir Patel M.D., of George Washington University
Enhancing diabetes and hypertension self-management: A randomized trial of a mobile phone strategy
Lawrence Cheskin, M.D., FACP, of Johns Hopkins Bloomberg School of Health
Tailored Rapid Interactive Mobile Messaging (TRIMM) for weight control among the underserved
Kevin Clauson, Pharm.D., of Nova Southeastern University
Pilot study to assess the impact of SMS/text messages on medication adherence for Type 2 diabetes
David Lindeman, MSW, Ph.D., of the Public Health Institute
Patient-centered mHealth: New horizons in diabetes care at Family Health Centers of San Diego
Sanjay Arora, M.D., Michael Menchine, M.D., and Anne Peters, M.D., at the University of Southern California
Improving diabetes care for low-income Latino patients in the Los Angeles County healthcare system
The Impact of Diabetes
Diabetes poses a serious and growing health risk in the United States. According to the American Diabetes Association:
25.8 million American children and adults have diabetes (8.3% of the population) 79 million people in the United States have pre-diabetes
$174 billion was spent in the United States in 2007 on direct medical costs and indirect costs, such as work loss and premature mortality
Minority populations disproportionately suffer from diabetes and diabetes-related complications
The McKesson Foundation pledged to put diabetes management at the forefront of its Mobilizing for Healthsm grant program when it launched the initiative in April 2010, and will continue to focus its funding priorities on diabetes management and research through March 2012.
JDRF Clinical Panel Recommends Next Steps For Artificial Pancreas Clinical Testing
Diabetes experts at a meeting convened by the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) took the next step in advancing efforts toward the development of an artificial pancreas: putting forth clinical recommendations to ensure the safe and effective testing of artificial pancreas technology in real-life situations. We are pleased at today's meeting there was a strong consensus among leading clinicians, researchers and industry leaders regarding the path toward outpatient studies for both low-glucose suspend and artificial pancreas systems.
Even with treatments available today, tight blood sugar control remains a challenge and daily struggle for those living with type 1 diabetes. In fact, the majority of people living with the disease are not achieving recommended target levels. "An artificial pancreas, essentially a device that would both measure blood sugar and dispense appropriate amounts of insulin to keep levels in optimal range, would take much of the guesswork out of daily management of the disease," said Dr. Aaron Kowalski, Assistant Vice President of Treatment Therapies at JDRF. "In the long-run, controlled blood sugar levels will help to lessen or avert the devastating complications from type 1 diabetes."
To date, artificial pancreas devices have been successfully tested in controlled inpatient or hospital settings, demonstrating the potential for this technology to improve blood sugar control. Now it must be tested safely in real-world conditions. And clear and reasonable regulatory guidelines must be established to ensure that the upcoming studies advance the technology to reach patients as soon as possible.
"We believe a safe and effective first generation artificial pancreas system is possible with today's technology, even as we continue to encourage development of improved devices. Experts at today's FDA workshop outlined a clear path forward to safely speed the development and delivery of artificial pancreas systems to patients," said Jeffrey Brewer, President and CEO of JDRF.
To help advance these efforts, JDRF formed a Clinical Panel of internationally renowned leaders in the diabetes field to make recommendations to FDA on key clinical steps and issues critical to the advancement of studies of these systems outside of the hospital. Panel members speaking at today's workshop included David Nathan, Director, Clinical Research Center and Diabetes Center at Massachusetts General Hospital and Professor of Medicine, Harvard Medical School; and William Tamborlane, Professor and Chief of Pediatric Endocrinology and Diabetes, Yale University School of Medicine.
The panel developed a series of clinical recommendations that were shared at today's meeting. They were based on key areas addressed by the FDA, NIH, JDRF, clinicians and industry. First, the recommendations addressed questions on how should studies on artificial pancreas systems move safely from inpatient (hospital) settings to outpatient (real-world) testing. Second, the panel identified which subset of patients should be considered when testing artificial pancreas systems. The third area focused on how to ensure the safety of patients participating in the studies and eventually for everyday use. Lastly, the panel identified what outcomes should be measured in studies to demonstrate the safety and effectiveness of the device.
According to panel chair Robert Sherwin, M.D., Yale University, "The panel believes, with certain safeguards, artificial pancreas systems can be safely tested in real world settings."
"The incidence of type 1 diabetes is on the rise. Today's tools to manage the disease are insufficient. We have the technology at our disposal to make an artificial pancreas work. Now it's time to move forward quickly to define the regulatory pathway so final studies can be completed and better technologies can be made available to adults and children struggling with this difficult disease," added Mr. Brewer.
About JDRF's Artificial Pancreas Project
JDRF launched the Artificial Pancreas Project in 2005 to speed the development of automated diabetes management systems. A self-regulating system, the artificial pancreas would be able to sense sugar levels continuously and automatically release the right amount of insulin at the right times eliminating the need for multiple blood tests, insulin injections and therefore lifting the daily burden associated with managing diabetes.
Since that time, JDRF has supported a number of initiatives that have advanced progress toward the development of an artificial pancreas. This has included the formation of the Artificial Pancreas Consortium, a group of university-based mathematicians, engineers, and diabetes experts to develop the computer algorithms that are needed to connect the devices needed to form a closed-loop system.
In addition to the consortium, JDRF has collaborated with several industry partners to develop a first-generation artificial pancreas system, as well as better and faster-acting insulin products, a key component of developing a safe and effective artificial pancreas system.
Even with treatments available today, tight blood sugar control remains a challenge and daily struggle for those living with type 1 diabetes. In fact, the majority of people living with the disease are not achieving recommended target levels. "An artificial pancreas, essentially a device that would both measure blood sugar and dispense appropriate amounts of insulin to keep levels in optimal range, would take much of the guesswork out of daily management of the disease," said Dr. Aaron Kowalski, Assistant Vice President of Treatment Therapies at JDRF. "In the long-run, controlled blood sugar levels will help to lessen or avert the devastating complications from type 1 diabetes."
To date, artificial pancreas devices have been successfully tested in controlled inpatient or hospital settings, demonstrating the potential for this technology to improve blood sugar control. Now it must be tested safely in real-world conditions. And clear and reasonable regulatory guidelines must be established to ensure that the upcoming studies advance the technology to reach patients as soon as possible.
"We believe a safe and effective first generation artificial pancreas system is possible with today's technology, even as we continue to encourage development of improved devices. Experts at today's FDA workshop outlined a clear path forward to safely speed the development and delivery of artificial pancreas systems to patients," said Jeffrey Brewer, President and CEO of JDRF.
To help advance these efforts, JDRF formed a Clinical Panel of internationally renowned leaders in the diabetes field to make recommendations to FDA on key clinical steps and issues critical to the advancement of studies of these systems outside of the hospital. Panel members speaking at today's workshop included David Nathan, Director, Clinical Research Center and Diabetes Center at Massachusetts General Hospital and Professor of Medicine, Harvard Medical School; and William Tamborlane, Professor and Chief of Pediatric Endocrinology and Diabetes, Yale University School of Medicine.
The panel developed a series of clinical recommendations that were shared at today's meeting. They were based on key areas addressed by the FDA, NIH, JDRF, clinicians and industry. First, the recommendations addressed questions on how should studies on artificial pancreas systems move safely from inpatient (hospital) settings to outpatient (real-world) testing. Second, the panel identified which subset of patients should be considered when testing artificial pancreas systems. The third area focused on how to ensure the safety of patients participating in the studies and eventually for everyday use. Lastly, the panel identified what outcomes should be measured in studies to demonstrate the safety and effectiveness of the device.
According to panel chair Robert Sherwin, M.D., Yale University, "The panel believes, with certain safeguards, artificial pancreas systems can be safely tested in real world settings."
"The incidence of type 1 diabetes is on the rise. Today's tools to manage the disease are insufficient. We have the technology at our disposal to make an artificial pancreas work. Now it's time to move forward quickly to define the regulatory pathway so final studies can be completed and better technologies can be made available to adults and children struggling with this difficult disease," added Mr. Brewer.
About JDRF's Artificial Pancreas Project
JDRF launched the Artificial Pancreas Project in 2005 to speed the development of automated diabetes management systems. A self-regulating system, the artificial pancreas would be able to sense sugar levels continuously and automatically release the right amount of insulin at the right times eliminating the need for multiple blood tests, insulin injections and therefore lifting the daily burden associated with managing diabetes.
Since that time, JDRF has supported a number of initiatives that have advanced progress toward the development of an artificial pancreas. This has included the formation of the Artificial Pancreas Consortium, a group of university-based mathematicians, engineers, and diabetes experts to develop the computer algorithms that are needed to connect the devices needed to form a closed-loop system.
In addition to the consortium, JDRF has collaborated with several industry partners to develop a first-generation artificial pancreas system, as well as better and faster-acting insulin products, a key component of developing a safe and effective artificial pancreas system.
UC Davis Researchers Discover Novel Pathway To Increased Inflammation In Diabetes Patients
Researchers at UC Davis Health System have
discovered a novel pathway that results in increased inflammation of blood
vessels in patients with type 1 diabetes. Their findings suggest that,
with
good diabetes control, this inflammation may be reduced, possibly
resulting
in a reduction of cardiovascular disease as well.
In a study now available both in the online edition of the Journal of
Clinical Endocrinology & Metabolism as well on the National Institutes of
Health's PubMed, the researchers provide the first-ever demonstration of
increased expression and signaling in type 1 diabetics of two key
receptors
within the body's innate immune system. Called TLR2 and TLR4, they are
part
of a family of pattern recognition receptors known as Toll-like receptors
(TLRs), so-called because of their similarities to the well-defined Toll
gene found in much-studied fruit flies.
Type 1 diabetes is a pro-inflammatory state associated with increased
cardiovascular mortality. Inflammation plays a pivotal role in all stages
of atherosclerosis, the progressive narrowing and hardening of the
arteries
over time. The UC Davis study found that TLR2 and TLR4 expression and
signaling are increased in type 1 diabetes patients and contribute to the
pro-inflammatory state.
"It is not unreasonable to speculate that TLR2 and TLR4 promote
atherogenesis by contributing to the pro-inflammatory state in type 1
diabetes," said lead author Ishwarlal Jialal, director of the Laboratory
for Atherosclerosis and Metabolic Research and professor of internal
medicine at UC Davis. "Inflammation is central to heart disease, playing a
pivotal role in plaque formation and stroke. We may well find that a
serendipitous byproduct of controlling diabetes is the simultaneous
control
of this new pathway, leading to less inflammation and lower risk of heart
problems."
The study represents the first-ever demonstration of increased TLR2 and
TLR4 activity in type 1 diabetes monocytes, which are part of the body's
immune system, protecting against blood-borne pathogens by moving quickly
to sites of infection. The immune system comprises the cells and
mechanisms
that defend the host from infection by other organisms, accomplishing its
defense with the help of such pattern-recognition receptors as TLRs for
early detection of specific classes of pathogens.
"This finding provides us with a totally new insight into the causes of
inflammation in diabetics," adds Jialal, who holds the Robert E. Stowell
Endowed Chair in Experimental Pathology at UC Davis. "It's an exciting
development in the emerging area of TLR research that has potentially
wide-ranging implications."
Further studies will use mice to examine the molecular mechanisms for
increased TLR2 and TLR4 expression and determine their contribution to the
pro-inflammatory state of diabetes.
Co-authors were Sridevi Devaraj, Mohan Dasu and Jason Rockwood in the UC
Davis Laboratory for Atherosclerosis and Metabolic Research; Steven
Griffen, UC Davis assistant professor of endocrinology, clinical nutrition
and vascular medicine; and William Winter, professor of pathology,
immunology and laboratory medicine at the University of Florida.
The study was funded by grants from the Juvenile Diabetes Research
Foundation International and the National Institutes of Health.
UC Davis Health System is the leading tertiary care provider for a
33-county region of Northern California. Research strengths at UC Davis
Health System include clinical and translational science, stem cell
science, infectious diseases, vascular biology, neuroscience, cancer,
functional genomics and mouse biology, comparative medicine, combinatorial
chemistry and nutrition, among many others.
UC Davis Health System
discovered a novel pathway that results in increased inflammation of blood
vessels in patients with type 1 diabetes. Their findings suggest that,
with
good diabetes control, this inflammation may be reduced, possibly
resulting
in a reduction of cardiovascular disease as well.
In a study now available both in the online edition of the Journal of
Clinical Endocrinology & Metabolism as well on the National Institutes of
Health's PubMed, the researchers provide the first-ever demonstration of
increased expression and signaling in type 1 diabetics of two key
receptors
within the body's innate immune system. Called TLR2 and TLR4, they are
part
of a family of pattern recognition receptors known as Toll-like receptors
(TLRs), so-called because of their similarities to the well-defined Toll
gene found in much-studied fruit flies.
Type 1 diabetes is a pro-inflammatory state associated with increased
cardiovascular mortality. Inflammation plays a pivotal role in all stages
of atherosclerosis, the progressive narrowing and hardening of the
arteries
over time. The UC Davis study found that TLR2 and TLR4 expression and
signaling are increased in type 1 diabetes patients and contribute to the
pro-inflammatory state.
"It is not unreasonable to speculate that TLR2 and TLR4 promote
atherogenesis by contributing to the pro-inflammatory state in type 1
diabetes," said lead author Ishwarlal Jialal, director of the Laboratory
for Atherosclerosis and Metabolic Research and professor of internal
medicine at UC Davis. "Inflammation is central to heart disease, playing a
pivotal role in plaque formation and stroke. We may well find that a
serendipitous byproduct of controlling diabetes is the simultaneous
control
of this new pathway, leading to less inflammation and lower risk of heart
problems."
The study represents the first-ever demonstration of increased TLR2 and
TLR4 activity in type 1 diabetes monocytes, which are part of the body's
immune system, protecting against blood-borne pathogens by moving quickly
to sites of infection. The immune system comprises the cells and
mechanisms
that defend the host from infection by other organisms, accomplishing its
defense with the help of such pattern-recognition receptors as TLRs for
early detection of specific classes of pathogens.
"This finding provides us with a totally new insight into the causes of
inflammation in diabetics," adds Jialal, who holds the Robert E. Stowell
Endowed Chair in Experimental Pathology at UC Davis. "It's an exciting
development in the emerging area of TLR research that has potentially
wide-ranging implications."
Further studies will use mice to examine the molecular mechanisms for
increased TLR2 and TLR4 expression and determine their contribution to the
pro-inflammatory state of diabetes.
Co-authors were Sridevi Devaraj, Mohan Dasu and Jason Rockwood in the UC
Davis Laboratory for Atherosclerosis and Metabolic Research; Steven
Griffen, UC Davis assistant professor of endocrinology, clinical nutrition
and vascular medicine; and William Winter, professor of pathology,
immunology and laboratory medicine at the University of Florida.
The study was funded by grants from the Juvenile Diabetes Research
Foundation International and the National Institutes of Health.
UC Davis Health System is the leading tertiary care provider for a
33-county region of Northern California. Research strengths at UC Davis
Health System include clinical and translational science, stem cell
science, infectious diseases, vascular biology, neuroscience, cancer,
functional genomics and mouse biology, comparative medicine, combinatorial
chemistry and nutrition, among many others.
UC Davis Health System
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