Study Identifies Possible Protective Blood Factors Against Type 2 Diabetes

BRONX, N.Y., May 3, 2012 /PRNewswire via COMTEX/ — Researchers at Albert Einstein College of Medicine of Yeshiva University in collaboration with Nurses’ Health Study investigators have shown that levels of certain related proteins found in blood are associated with a greatly reduced risk for developing type 2 diabetes up to a decade or more later. The findings, published today in the online edition of Diabetes, could open a new front in the war against diabetes.

These proteins are part of what is called the IGF axis. This axis was named for insulin-like growth factor-1, (IGF-1), so called because it has biological effects similar to those of insulin (the hormone that regulates blood glucose levels) but has a greater effect on cell growth than insulin. The researchers also looked at levels of several proteins known as IGF binding proteins, or IGFBPs, that may have strong effects independent of IGF-1.

Researchers have hypothesized that the IGF axis may influence risk for developing diabetes – an idea supported by laboratory and mouse studies, and a few initial studies in humans. However, the current study is the first large, prospective investigation of several components of the IGF-axis and the risk for developing diabetes, according to co-senior author Howard Strickler, M.D., M.P.H., professor of epidemiology & population health at Einstein.

In the current study, the researchers analyzed levels of IGF-1, IGFBP-1, IGFBP-2, and IGFBP-3 in blood taken from 742 women in the Nurses’ Health Study who years later developed type 2 diabetes as well as a similar number of women in the study who did not develop diabetes. None of the women had any signs or symptoms of the disease at the time their blood samples were taken. The median time between the taking of blood samples and diabetes onset was nine years.

Each component of the IGF axis (IGF-1 and IGFBP-1, -2, and -3) had a significant independent association with diabetes risk – most notably IGFBP-1 and -2. Compared with women in the bottom 20 percent with respect to their levels of IGFBP-1, having high levels of IGFBP-1 (top 20 percent) was associated with a three-fold reduction in risk for diabetes, while high levels of IGFBP-2 were associated with a more than five-fold reduction in diabetes risk.

“Our data provide important new evidence that circulating IGF-axis proteins may have a role in the development of type 2 diabetes,” said Dr. Strickler.

The findings have potential clinical implications. First of all, IGF-axis proteins could help in stratifying people at risk for diabetes. “For example,” said Dr. Strickler, “we know that obesity is a major risk factor for diabetes. But some overweight individuals don’t develop diabetes, while some thin people do. If our findings are confirmed, they could help doctors more precisely determine who is actually at risk for the disease.”

The proteins may also prove useful as targets for novel therapies to prevent or treat diabetes. But Dr. Strickler cautions that it’s too early to apply these findings to clinical practice. “IGF-axis proteins have other effects, some beneficial and some not,” he notes. “We need to learn more about the connection between the IGF-axis and diabetes before we recommend that people get tested for these substances, and before deciding how we can exploit the IGF-1 axis to help address diabetes.”

The Diabetes paper is titled, “The Insulin-Like Growth Factor Axis and Risk of Type 2 Diabetes in Women.” The first author was Swapnil Rajpathak (who was at Einstein at the time this work was conducted). The other senior author is Frank B. Hu, M.D., Ph.D, of Harvard School of Public Health, Boston, MA. Additional contributors include Meian He, M.D., Ph.D., (Harvard and Huazhong University of Science and Technology, Wuhan, Hubei, China); Qi Sun M.D., Sc.D., (Harvard); Jeannette Beasley, Ph.D., R.D., M.P.H., (Fred Hutchinson Cancer Research Center, Seattle, WA); Michael Pollak, M.D., (McGill University, Montreal, Quebec, Canada); and Robert Kaplan, Ph.D., Radhika Muzumdar M.D., M.B.B.S., Thomas Rohan, M.D., Ph.D., Mimi Kim, Sci.D., Jeffrey Pessin, Ph.D., and Judith Wylie-Rosett, Ed.D., all of Einstein. Co-author Marc Gunter, Ph.D., contributed to the paper while at Einstein.

The study was supported by grants from the National Institutes of Health. Laboratory testing and data analysis were supported in part by NIDDK 5-R01-DK-080792. The NHS is supported by grants CA-87969, DK-58845, and DK-58785 from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Child Health and Human Development. Q.S. was supported by a career development award (K99HL098459) from the National Heart, Lung, and Blood Institute. The authors report no conflicts of interest.

About Albert Einstein College of Medicine of Yeshiva University

Albert Einstein College of Medicine of Yeshiva University is one of the nation’s premier centers for research, medical education and clinical investigation. During the 2011-2012 academic year, Einstein is home to 724 M.D. students, 248 Ph.D. students, 117 students in the combined M.D./Ph.D. program, and 368 postdoctoral research fellows. The College of Medicine has 2,522 full time faculty members located on the main campus and at its clinical affiliates. In 2011, Einstein received nearly $170 million in awards from the NIH. This includes the funding of major research centers at Einstein in diabetes, cancer, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership with Montefiore Medical Center, the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Through its extensive affiliation network involving Montefiore, Jacobi Medical Center – Einstein’s founding hospital, and five other hospital systems in the Bronx, Manhattan, Long Island and Brooklyn, Einstein runs one of the largest post-graduate medical training programs in the United States, offering approximately 155 residency programs to more than 2,200 physicians in training. For more information, please visit www.einstein.yu.edu and follow us on Twitter @EinsteinMed.

SOURCE Albert Einstein College of Medicine

Copyright (C) 2012 PR Newswire. All rights reserved

 

Sanofi iBGStar® Blood Glucose Monitoring System Now Available in the U.S.

- First FDA Cleared Blood Glucose Meter that Connects Directly to iPhone® and iPod touch® – - Available at Apple® Retail Stores and Walgreens Nationwide, Online at Apple.com, Walgreens.com and through Diabetic Care Services – - Recipient of Two Design Awards for Outstanding Product Design -

BRIDGEWATER, N.J., May 2, 2012 /PRNewswire via COMTEX/ — Sanofi US announced today that the iBGStar® Blood Glucose Monitoring System, consisting of the iBGStar® blood glucose meter and iBGStar® Diabetes Manager App, is commercially available in the U.S. iBGStar® is the first Food and Drug Administration (FDA) cleared blood glucose meter that directly connects to the iPhone® and iPod touch®, offering accurate blood glucose monitoring that seamlessly integrates into the lives of people with diabetes. iBGStar® is available for purchase at Apple® Retail Stores and all Walgreens stores nationwide, online at Apple.com, Walgreens.com and through Diabetic Care Services.

To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/46108-sanofi-ibgstar-blood-glucose-monitoring-system

“Many people with diabetes today rely both on their iPhone® or iPod touch® and blood glucose monitors as important parts of their daily lives,” said Naina Sinha, MD, an in-patient diabetes attending physician and assistant professor of medicine at a leading academic medical center and university in New York City. “By combining these two essential tools, iBGStar® makes it possible to provide blood glucose tracking, monitoring and reporting together in a new way.”

About iBGStar®When iBGStar® is directly connected to an iPhone® or iPod touch® and used with the iBGStar® Diabetes Manager App, blood glucose results are presented on the Multi-Touch display quickly after monitoring.

iBGStar® can also be used independently to measure blood glucose levels; results can be synchronized later to an iPhone® or iPod touch®. iBGStar® and BGStar® Blood Glucose Test Strips, which are used with iBGStar®, are available at all Walgreens stores nationwide and online at Walgreens.com and through Diabetic Care Services. These test strips may be covered under certain health insurance plans so individuals should check directly with their provider.

The iBGStar® Diabetes Manager App has a range of features and multiple views for analyzing glucose patterns on-the-go. Visual graphs and statistics can help people record and track their readings, carbohydrate intake, insulin doses (if taking insulin) and more. Color-coded scorecards show individual monitoring results for easy identification of high or low blood glucose levels. A ‘share’ function allows specific data to be sent via e-mail to caregivers and/or healthcare teams. The iBGStar® Diabetes Manager App is available for free from the App Store on iPhone® and iPod touch® or at www.itunes.com/appstore .

“Sanofi is pleased to launch iBGStar®, which expands our diabetes portfolio as we pursue comprehensive disease management offerings and further illustrates our commitment to developing innovative solutions that help improve the lives of people with diabetes,” commented Dennis Urbaniak, Vice President, Head of U.S. Diabetes, Sanofi US. “The iBGStar® Blood Glucose Monitoring System will help people living with diabetes check their blood sugar and communicate with their healthcare teams, using mobile technologies that have become central to so many people’s lives.”

In March 2010, Sanofi and AgaMatrix signed an agreement for the development, supply and commercialization of Blood Glucose Monitoring solutions. iBGStar® is a result of this agreement.

iBGStar® received the Good Design(TM) Award in 2011 for outstanding product design in the medical category from the Chicago Athenaeum of Architecture and Design and the European Centre for Architecture Art Design and Urban Studies. Additionally, iBGStar® received the red dot design award in 2011 for outstanding product design in the life science and medicine category. The red dot design award is one of the most renowned international design competitions ( www.red-dot.de/presse ), with almost 14,000 entries from 68 countries in 2010 alone. Winners are considered to be the best design in the industry worldwide.

Apple®, iPhone® and iPod touch® are trademarks of Apple Inc, registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Content purchased from the iTunes Store is for personal lawful use only. Don’t steal music.

For more information, visit www.ibgstar.us .

About the Sanofi Diabetes DivisionSanofi strives to help people manage the complex challenges of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insight that comes from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices, including innovative blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes. Investigational compounds in the pipeline include an injectable GLP-1 agonist being studied as a single agent, in combination with basal insulin, and/or in combination with oral antidiabetic agents.

Important InformationThe iBGStar® meter and lancing device are for single patient use. Do not share them with anyone including other family members. Do not use on multiple patients. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris /quotes/zigman/187275 FR:SAN +0.97% and in New York /quotes/zigman/307926/quotes/nls/sny SNY +0.16% .

Sanofi is the holding company of a consolidated group of subsidiaries and operates in the United States as Sanofi US, also referred to as sanofi-aventis U.S. LLC. For more information on Sanofi US, please visit http://www.sanofi.us or call 1-800-981-2491.

Forward Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

US.BGM.12.02.076

SOURCE Sanofi US

Copyright (C) 2012 PR Newswire. All rights reserved

 

Kid’s Type 2 Diabetes Difficult to Treat

Type 2 diabetes was once considered an adult disease. Not so anymore. Kids are being diagnosed at an alarming rate, and now a new study says that these children are going to have a tougher time getting the disease under control.

Obesity and lack of physical activity are two of the most common reasons someone gets type 2 diabetes. During the past three decades, the tripling of obesity in children has gone hand in hand with an increase of type 2 diabetes in children.

What is type 2 diabetes? It begins when the body develops a resistance to insulin and cannot use insulin properly. The pancreas is no longer able to produce sufficient amounts of insulin to control blood sugar. Hyperglycemia is the medical term for high blood sugar levels. The reason it is so bad is that hyperglycemia can damage the vessels that supply blood to vital organs, which can increase the risk of heart disease and stroke, kidney disease, vision problems, and nerve problems.

In a large new trial looking at ways to slow the progression of type 2 diabetes in children and teens, the addition of a second drug to the mainstay treatment metformin was only marginally more effective at controlling blood sugar than metformin alone.

Within a year, on average, half of kids on metformin and some 40 percent taking both metformin and rosiglitazone (Avandia) ended up having to resort to insulin injections to control their blood sugar, researchers reported Sunday at the annual meeting of the Pediatric Academic Societies in Boston and in the New England Journal of Medicine online.

“The results of the study were discouraging,” said Dr. David Allen from the University of Wisconsin School of Medicine and Public Health in an NEJM editorial. “These data imply that most youth with type 2 diabetes will require multiple oral agents or insulin therapy within a very few years after diagnosis.”

All 699 children included in the study had been diagnosed with type 2 diabetes two years or less before enrollment, so the rapid advance of about half to needing insulin marks an early start to a potential lifetime of complications and side effects — from the diabetes itself and the medications used to treat the disease.

Type 2 diabetes “progresses more rapidly” in youth, according to Dr. Phil Zeitler from the University of Colorado, Denver, who worked on the new study.

He and his colleagues were surprised at how quickly many of the youngsters needed to switch from oral medications to taking daily insulin shots, Zeitler told Reuters Health.

Also, Zeitler said, the teens in the study appeared to have complications, including infections and hospitalization, more often than adults do.

All the children in the study were overweight or obese, and ranged in age from 10 to 17 years old.

Children also may have a more difficult time taking their medications as instructed and are not usually in control of what is given to them to eat. Fast food dining has become a staple for many American families. School lunches are not much better in some regions, and kids are simply not as active as in past generations. Zeitler noted “the toxicity of your lifestyle must be pretty severe,” for young children and teens to get type 2 diabetes before adulthood.

That’s why all of the kids in the study got at least “basic lifestyle counseling,” he emphasized — for example, advice to stop drinking sugared sodas, eat less fast food, watch their diet in other healthy ways, take stairs instead of elevators and generally get more exercise.

Study enrollment began in July 2004 and follow-up continued through February 2011. All the kids in the study were taking metformin, a well-established diabetes drug, and a third were assigned to take the newer drug Avandia as well.

Another third of the kids were assigned a very intensive “lifestyle intervention,” that involved more assignments for kids to complete, more interaction with counselors, and close involvement of at least one parent, in addition to taking metformin.

The kids’ treatments were deemed failures if blood sugar and other signs pointed to their diabetes not being under control for a period of six months or more.

In the end, 52 percent of kids on metformin alone “failed” treatment, along with 39 percent of kids on metformin and Avandia and 47 percent of kids on metformin and lifestyle changes.

The median time it took for blood sugar control to be lost was just under a year.

The added benefit of Avandia was limited to girls, for reasons that are unclear, the researchers reported.

Also for unknown reasons, they noted, metformin alone was less effective for non-Hispanic black participants than other kids.

Overall, 19 percent of the participants developed serious adverse effects such as severe hypoglycemia, diabetic ketoacidosis and lactic acidosis.

The rate in the treatment groups was 18 percent in the metformin-only group, 15 percent in the double-drug group and 25 percent in the group that received the very intensive lifestyle intervention. The rate of specific problems such as hyperglycemia, were not significantly higher between the groups.

Fifty years ago,” the editorial continues, “children did not avoid obesity by making healthy choices; they simply lived in an environment that provided fewer calories and included more physical activity for all. Until a healthier ‘eat less, move more’ environment is created for today’s children, lifestyle interventions like that in the …study will fail.”

Type 2 diabetes can be difficult to diagnose in children because they may go without symptoms for a long time. A blood test to measure glucose metabolism is needed for an accurate diagnosis.

Mayoclinic.com gives these symptoms to be aware of.

- Increased thirst and urination. As excess sugar builds up in your child’s bloodstream, fluid is pulled from the tissues. This may leave your child thirsty. As a result, your child may drink — and urinate — more than usual.

- Increased hunger. Without enough insulin to move sugar into your child’s cells, your child’s muscles and organs become depleted of energy. This triggers hunger.

- Weight loss. Despite eating more than usual to relieve hunger, your child may lose weight. Without the energy sugar supplies to your cells, muscle tissues and fat stores simply shrink.

- Fatigue. If your child’s cells are deprived of sugar, he or she may become tired and irritable.

- Blurred vision. If your child’s blood sugar is too high, fluid may be pulled from the lenses of your child’s eyes. This may affect your child’s ability to focus clearly.

- Slow-healing sores or frequent infections. Type 2 diabetes affects your child’s ability to heal and resist infections.

- Areas of darkened skin. Areas of darkened skin (acanthosis nigricans) may be a sign of insulin resistance. These dark patches often occur in the armpits or neck.

Treating type 2 diabetes is much more difficult than preventing it. Long-term diabetes can have devastating results on your health. That’s why it’s so important for families to be aware of the disease and what it takes to help prevent it.

Sources: http://www.mayoclinic.com/health/type-2-diabetes-in-children/DS00946/DSECTION=symptoms

http://www.reuters.com/article/2012/04/30/us-diabetes-kids-idUSBRE83T17K20120430

Telcare’s Wireless-Enabled Blood Glucose Monitoring System Wins 2012 Gold Edison Award

Telcare’s New Diabetes Care Management Device Recognized As Best New Science and Medical Online Tool/App

New York, NY (PRWEB) April 27, 2012

Telcare’s wireless enabled blood glucose monitoring system received the 2012 Gold Edison Award for the best new medical and science online tool and app. Today marks the 25th annual Edison Awards competition, which honors the year’s most innovative products, services and business leaders in the world.

Telcare’s FDA-cleared device, introduced in February 2012, wirelessly communicates critical information to diabetes patients, doctors, caregivers and iPhones. It’s the first blood glucose monitor that uses cellular communication to instantly transmit a patient’s readings to a private online database, which can be accessed by the patient or – with permission – by a doctor, caregiver or family member. It tracks results and can spot potential problems and transmits real-time feedback.

“It’s a great honor for Telcare to receive Edison’s top award for innovation,” said Telcare CEO Dr. Jonathan Javitt. “Edison searches for the latest cutting-edge devices and we believe Telcare’s wireless-enabled blood glucose monitor has the capability to transform the lives of 28 million Americans with diabetes.”

Telcare’s blood glucose monitoring system includes Diabetes Pal, currently the highest rated diabetes smartphone app. Diabetes Pal works seamlessly with the Telcare meter to enable family members of people with diabetes to view results in real time and to provide Telcare meter users a diabetes-focused social networking experience. Telcare has chosen to distribute Diabetes Pal at no charge via the Apple iTunes store (and soon via the Google app store) so that people may use it even without purchasing the Telcare system.

“By incorporating wireless communication, social networking, and best practices in health IT, Telcare has brought the monitoring of diabetes into the 21st century for 28 million Americans, their caregivers, and their loved ones,” Dr. Javitt added.

Each year the Edison Awards recognize the world’s most significant innovations. Past winners include Apple for the iPad, Amazon for the Kindle II, and Nintendo for WiiFit. Once again, the 2012 awards drew a group of competitors.

“The Telcare Blood Glucose Monitoring System is an excellent example of an innovative product that reflects the rich tradition of the Edison Awards,” said Thomas Stat, Chairman of the Edison Awards Steering Committee. “By awarding Telcare with the Edison Gold Medal, we have recognized this wireless system as a significant step forward for 28 million diabetics in this country as they pursue healthier, more meaningful lives.”

Telcare was also recently named to Gartner’s list of “Cool Vendors.” Gartner’s analysts praised Telcare’s system for “getting the technology right” and providing “effective solutions” for diabetes care.” According to Gartner, “This is the same technology that made Kindle the book reader that grandma loves.”

About Telcare
Telcare, Inc. uses cellular technology and social networking to bridge the last mile between patients with diabetes, their caregivers, and their families in order to transform the care of chronic illness. Telcare has been awarded First Place prizes in the categories of Health, Wellness and Fitness Application and Health Enterprise Solution by CTIA, been named the MEDTEC startup of the year, and been named one of the top 12 products of 2012 by the Edison Awards. In addition to directly reducing cost of care by improving outcomes and preventing complications, Telcare creates an ecosystem of care that enables people with diabetes to better care for their condition. For more information, visit www.telcare.com.

About the Edison Awards and Edison Universe
The Edison Awards were established in 1987 to honor and advance Thomas Edison’s wideranging contributions to technology and consumer products, as well as to inspire continued innovation in the world. In addition to the Edison Achievement Award, the organization also recognizes new product and service innovations through its annual Edison Awards and Edison Green Awards and, through its non-profit organization, Edison Universe, supports future innovators and fosters future innovation. For more information, visit www.edisonawards.com.

‘Inadequate’ NHS diabetes care causing patients ‘harm’ By Mike Tighe

People with diabetes need to check their blood sugar levels.

NHS diabetes care is ‘inadequate’ and some patients come to further harm due to poor care in hospital, a leading specialist says.

Dr Gerry Rayman, national clinical lead for inpatient diabetes, warned many hospitals had no specialist diabetes nurse.

He said many hospital patients had diabetes, and called the situation ‘quite alarming’.

The Department of Health said work was under way to improve care standards.

Speaking on BBC Radio 4′s You and Yours, Dr Rayman, head of the diabetes service at Ipswich Hospital NHS Trust, said: “We know that one in three hospitals don’t have a specialist diabetes nurse, which is really quite alarming when we know that one in six people in hospital have diabetes.

“Unfortunately, many people in hospital with diabetes do come to harm as a result of, I’m afraid to say, inadequate care in hospital.”

Diabetes accounts for 11% of all NHS inpatient expenditure, and costs the service around £23.7bn last year, a figure projected to increase to just under £40bn by 2035.

Two types

Diabetes complications

  • Diabetes that is not controlled can cause many serious long-term problems.
  • Excess glucose (sugar) in the blood can damage the blood vessels, contributing to heart disease, strokes, kidney disease, impotence and nerve damage.
  • Uncontrolled diabetes is the most common cause of blindness in people of working age.
  • People with diabetes are also 15% more likely to have an amputation than people without the condition.

In Type 2 diabetes, not enough insulin is produced or the insulin that is made by the body does not work properly.

It tends to affect people as they get older and usually appears after the age of 40, but increasingly is seen in younger, overweight people. It accounts for 90% of all cases.

Type 1 diabetes, a condition which usually means insulin cannot be produced at all, is responsible for the other 10%.

Adrian Sanders, chair of the all-party parliamentary group for diabetes, claimed there was plenty of evidence out there to support Dr Rayman’s assessment.

He said the government was aware that a disproportionate number of people occupying hospital beds have diabetes, and their hospital stays are longer.

He said the government – and the last Labour administration – had encouraged more support for people with diabetes in primary care.

“That’s actually a very good policy for people whose condition doesn’t present complications or specialisms. And that’s why you need specialist care for those who present with specialist problems.”

Barbara Young, chief executive at Diabetes UK, said diabetes was a serious condition which could lead to devastating long term complications including blindness, kidney failure and amputations.

She said: “The tragedy is that for many people with diabetes, complications could have been avoided if the health checks were in place to spot any signs and if the appropriate care and treatment were applied.

“For example, up to 80% of amputation cases due to diabetes could be avoided if problems are identified early enough and treated appropriately.”

Personal responsibility

A key area of contention is whether diabetes is an issue for social or personal responsibility, with some arguing for tougher regulation of the food industry, whilst others argue healthy diet is strictly a matter for the individual.

Last week a ten-minute rule bill was introduced in the House of Commons by Keith Vaz arguing for the reduction of sugar content in soft drinks by 4%.

However, Paul McArdle, of the British Dietetic Association, cautioned against putting too much emphasis on sugar in food.

He said: “Food labelled ‘suitable for diabetics’ comes from the misguided principal that everything for people with diabetes is about sugar.

“The main focus for this group is losing weight and having a healthy diet, as this helps people with diabetes manage the condition.

“Around 60-90% of type two diabetes is caused by people being overweight, with more than half of that being preventable by having a healthy lifestyle.

“The bigger issue is good food labelling which can enable consumers of food to make healthy choices.”

Audit for improvement

The Department of Health issued a statement which accepted that good diabetes care was very important in hospital – and elsewhere.

“That is why the National Diabetes Inpatient Audit reviews diabetes management in hospital each year and feeds results back to individual hospitals to take appropriate action.

“NHS Diabetes is working with clinicians through their Inpatient Network to improve care.

“The Audit has already shown some improvements in care but more needs to be done.”

Merck Profit Tops Analyst Estimates on Diabetes Drugs

Merck & Co. (MRK), the second-largest U.S. drugmaker, reported first-quarter profit that beat analyst estimates on higher sales of diabetes treatments.

Net income rose 67 percent to $1.74 billion, or 56 cents a share, from a year earlier, the Whitehouse Station, New Jersey- based company said today in a statement. Earnings per share excluding one-time items beat by 1 cent the 98-cent average of 18 analyst estimates compiled by Bloomberg.

Revenue climbed 1.3 percent to $11.7 billion, boosted by higher sales of the Januvia and Janumet diabetes drugs. Merck has been cutting thousands of jobs and trying to boost demand of existing products to prepare for when asthma treatment Singulair faces cheaper copies in August. Analysts say the focus now turns to the company’s medicines in development after research setbacks in recent years.

“Merck is emerging from a challenging 2011,” said Tony Butler, an analyst with Barclays Capital Inc. in New York, in a April 16 research report. “The stock has been on a path of recovery since last November, but this has been more correlated with the dividend increase and flow into the pharma sector as a whole than a restoration of sentiment around Merck’s innovation core.”

Merck boosted its dividend by 11 percent in November, the first increase since 2004. First-quarter net income in 2011 was $1.04 billion, or 34 cents, when Merck took a $500 million charge to settle a dispute with Johnson & Johnson. (JNJ)

Merck Shares

Merck rose less than 1 percent to $38.57 at 10:11 a.m. New York time. The shares had gained 9.7 percent in the 12 months before today.

Merck reiterated its 2012 forecast for earnings excluding one-time items of $3.75 to $3.85 a share, with net income projected to be $2.04 to $2.30. Revenue this year will be at or near 2011 levels on a constant currency basis, Merck said. At current exchange rates, sales would be hurt by 2 to 3 percent, according to the company.

Sales of Januvia jumped 24 percent to $919 million, while revenue from Janumet surged 29 percent to $392 million. The company’s human papillomavirus vaccine Gardasil increased 33 percent to $284 million.

Merck has five major products in development that the company is focusing on over the next two years. Investors are concerned about Merck’s research operations after the company halted a study of its experimental blood thinner vorapaxar, said Butler.

“Investor reactions toward these five candidates can be described as lukewarm if not cynical,” Butler said in the report. “Operational results in the quarter are unlikely to change sentiment, and we believe that Merck needs to deliver on pipelines to restore enthusiasm towards the stock.”

To contact the reporter on this story: Shannon Pettypiece in New York at spettypiece@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

 

Artificial pancreas gives girl vacation from diabetes

Elle Shaheen, 12, tests an artificial pancreas at Massachusetts General Hospital in January 2012.

Portsmouth, New Hampshire (CNN) — At 3:30 a.m., Stefany Shaheen awoke to a feeling of uneasiness. Something was not quite right with her daughter, Elle.

Creeping into her bedroom, Shaheen removed a lancet from its wrapper and poked her diabetic daughter’s finger.

Putting the blood onto the testing strip, she saw the results: dangerously low blood sugar. Shaheen woke Elle up and gave her orange juice to keep her from slipping into unconsciousness.

Shaheen was relieved her motherly intuition had told her something was wrong with Elle that night, but she wished she didn’t have to rely on it. She yearned for an automatic way of knowing when Elle was dipping into a dangerously high or low blood sugar — and not just at night, but at school, where the 12-year-old is largely responsible for monitoring her own blood sugar.

Then last week, Shaheen got her wish.

Elle was selected to try out an experimental device called an artificial or “bionic” pancreas. During the three-day study, Elle didn’t have to poke her finger every few hours to find out her blood sugar level because the “bionic” pancreas recorded it automatically and adjusted her insulin accordingly.

Shaheen didn’t have to set her alarm to wake up every three hours at night because the device was designed to catch a dangerously high or low blood sugar and treat it.

“For the first time since she was diagnosed, I didn’t have to worry,” says Shaheen, who lives in Portsmouth, New Hampshire.

Medical device companies are racing to be the first to market an artificial pancreas, which takes over the work of the diabetic’s malfunctioning organ. The device could potentially be used for Type 1 diabetics or Type 2 diabetics who use insulin.

“It’s transformative technology,” says Aaron Kowalski, assistant vice president for treatment therapies research at the Juvenile Diabetes Research Foundation.

JDRF is funding artificial pancreas trials at 13 sites worldwide, including Yale University, Stanford University, the University of Virginia and the University of Colorado. Device companies also are funding several other studies.

“It’s looking incredibly promising,” Kowalski says. “I hope very much we’ll have a system on the market within four years, and I’ll be very disappointed if we don’t.”

‘Pale and pasty … and all by herself’

It was Elle who urged her mother to enroll her in an artificial pancreas study.

The Shaheens first heard about the artificial pancreas shortly after Elle was diagnosed with diabetes at age 8, but she had to be 12 years old to enroll. So the day she turned 12 this past September, she started bugging her parents.

“She was constantly reminding me, ‘Mom, you need to call, you need to call,’” Shaheen remembers.

Her mother was only too happy to comply. There had been several middle-of-the-night close calls, plus some desperate situations at school where the staff nurse was responsible for 450 children and “ill-equipped,” Shaheen says, to handle the needs of a diabetic child.

“I got a call from Elle one morning. She was in the school office and her voice was trembling, and she said ‘Mom, I need you to come quick. I don’t know what’s wrong,’” Shaheen says. “I got there and her blood sugar was dropping like a rock. She was pale and pasty and sweating profusely and all by herself.”

A glimpse of the dream

In January, Elle walked into Massachusetts General Hospital to start the trial.

Doctors fitted her for an artificial pancreas. In the future, the device will be the size of a cell phone, but for now Elle is hooked up to a laptop.

For three days, the device did the work Elle’s pancreas can no longer do.

“It went very smoothly — her blood sugar control was really very, very good,” said Dr. Steven Russell, an instructor at Harvard Medical School. “We were really very pleased by what we saw with Elle.”

Russell’s research partner, Edward Diamano, an associate professor of biomedical engineering at Boston University, says the device learned Elle’s blood sugar patterns and made changes accordingly.

“It’s making adjustments every five minutes,” he says.

For that one weekend, Elle didn’t have to draw blood, and she could eat foods she hadn’t eaten in large quantities for four years.

“She ate Spaghetti-O’s and grilled cheese and french fries and hamburgers,” Shaheen says. “She ate between 67 and 100 grams of carbs a day, and usually she can only eat between 40 and 50.”

Then, after the experiment, Elle had to leave the artificial pancreas behind, and it was back to counting carbs and poking herself every couple of hours. Her mother reset the nighttime alarm clock.

“We’re extraordinarily impatient for access to the device,” Shaheen says. “I think it will revolutionize the way she lives.”

“That was really hard,” Elle says. “I just hope one day I can use it at home.”

Baby steps

Last week, Russell and Damiano visited the Food and Drug Administration offices in Silver Spring, Maryland, to show regulators a prototype for the artificial pancreas.

The device itself can be worn in a pocket or clipped to a belt. Two tiny pieces go under the skin, one to detect glucose levels in the blood and another to deliver insulin and Glucagon, a drug used to raise very low blood sugar.

Algorithms determine how much insulin and Glucagon the patient needs, and if necessary the patient can manually override the device.

So far, the FDA has required doctors to keep patients inside the hospital while their using the device.

The potential benefits are enormous, Dr. Charles Zimliki, who chairs the FDA’s Artificial Pancreas Critical Path Initiative, testified before a Senate committee last year. But “if not properly designed, use of an artificial pancreas device in an outpatient setting can place patients at significant risk.”

Russell said he hopes that by the fall, the FDA will give him permission to allow adult diabetic patients to leave the building and walk the grounds of the Massachusetts General Hospital campus accompanied by a nurse, eating as they like and using the hospital’s gym.

Then by the summer of 2013, he hopes to give the artificial pancreas to children attending a summer camp.

“These are all baby steps towards what we ultimately want to do, which is give them the device and say, ‘Go home and check back with us in a week,’” Russell says.

Shaheen is closely watching the proceedings at the FDA, with the help of her mother, Sen. Jeanne Shaheen, D-New Hampshire, who co-chairs the Senate Diabetes Caucus.

“We’re extraordinarily impatient for access to the device,” she says. “I think it will revolutionize the way she lives.”

Paula Deen: I Have Type 2 Diabetes

From fried chicken to mac and cheese casseroles, Paula Deen has made her mark on the culinary world – and in the homes of fans – with recipes that don’t skimp on cheese, cream and sugar. Not to mention butter … whole sticks of it.

And even as she reveals that she is living with Type 2 Diabetes, she says it won’t stop her from eating the way she wants.

“I was determined to share my positive approach and not let diabetes stand in the way of enjoying my life,” Deen said Tuesday in a release announcing her launch of Diabetes in a New Light™, geared toward finding “simple ways” to manage challenges of the disease.

“I’m excited to team up with Novo Nordisk on this initiative to show others that managing diabetes does not have to stop you from enjoying the things you love.”

The National Enquirer first reported Deen’s diabetes in April 2010, but she never confirmed or denied the diagnosis until now. She turns 65 Thursday.

The Food Network chef with the folksy Southern drawl – and a tendency to address her fans as “Hey, y’all” – has been famously criticized for her cooking techniques. Just last summer, fellow celeb chef Anthony Bourdain called her the “most dangerous person to America” who’s “proud of the fact that her food is f—— bad for you.”

And as news leaked she was making the announcement regarding her health, Bourdain was inundated with people “looking for quotes.” And he says he “takes no pleasure” in her news, telling Eater.com, he suspects she’s known for a long time and been looking for a way “to position herself.”

“When your signature dish is hamburger in between a doughnut, and you’ve been cheerfully selling this stuff knowing all along that you’ve got Type 2 Diabetes … It’s in bad taste if nothing else,” he said. “How long has she known? I suspect a very long time.”

Deen, it was also revealed in the release, takes Victoza – a once-daily, non-insulin injection – and continues to “make lifestyle adjustments, including lightened-up versions of her favorite recipes.”

 

Novel stem cell treatment may hold promise for type 1 diabetes

A new type of stem cell treatment for people with type 1 diabetes appears to help re-educate rogue immune system cells, which allows cells in the pancreas to start producing insulin again.

The treatment, which combines a patient’s immune system cells with stem cells from a donor’s cord blood, even worked in people with long-standing diabetes who were believed to have no insulin-producing ability.

Although the treatment didn’t wean anyone off insulin completely, average blood sugar levels dropped significantly, which would reduce the risk of long-term complications.

“Our study brings a new hope for people with type 1 diabetes. If we can control the autoimmunity, we may reverse the diabetes. We showed that the islets 1/8cells3/8 can start to work again,” said Dr. Yong Zhao, an assistant professor in the section of endocrinology, diabetes and metabolism at the University of Illinois at Chicago.

This treatment could potentially be useful in other autoimmune diseases, such as lupus and rheumatoid arthritis.

“It’s quite remarkable that this approach, based on the re-education of immune cells, might work so well. The concept is very intriguing, and the treatment seems to be so simple and so safe,” said Dr. Luca Inverardi, deputy director of translational research at the Diabetes Research Institute, University of Miami School of Medicine.

But he’s also “reasonably cautious,” he said. “The follow-up is long, up to 40 weeks, but it’s not long enough to declare victory against diabetes yet,” said Inverardi.

Also, he noted that the study involved only 15 Chinese people, and that type 1 diabetes is a bit different in that population. He said he’d like to see larger studies with a more diverse population, followed for a longer time.

Results of the study were published online Jan. 9 in the journal BMC Medicine.

Type 1 diabetes, an autoimmune disease, occurs when the body’s immune system cells mistakenly attack the insulin-producing (beta) cells in the pancreas. Because their beta cells don’t produce enough or any insulin, people with type 1 diabetes have to replace the lost insulin through injections to survive.

Stopping that autoimmune attack appears to be crucial to any treatment that hopes to cure or reverse type 1 diabetes.

Zhao’s team developed a completely new approach. They take blood from a patient and separate out the immune system cells (lymphocytes). They briefly expose those cells to stem cells from umbilical cord blood from an unrelated infant and return the lymphocytes alone to the patient’s body. The researchers have dubbed this “Stem Cell Educator Therapy,” because while exposed to the stem cells, the lymphocytes seem to relearn how they should behave.

The study participants, who were 15 to 41 years old, had had type 1 diabetes for an average of nine years. Six had some residual beta cell function and six did not. Both groups were given stem cell educator therapy. The other three people served as the control group.

The researchers measured C-peptide, a protein fragment that’s a byproduct of insulin production, and found that the educator therapy group had improved levels of C-peptide at 12 weeks. These levels continued to improve until 24 weeks, and remained stable through the follow-up at 40 weeks. There were no changes in C-peptide in the control group.

The average daily dose of insulin dropped almost 39 percent after 12 weeks for the group with some beta cell function and 25 percent in those with no beta cell function, suggesting that the group with no beta cell function now produced insulin.

“That means if you stop the autoimmune reaction, you may see beta cell regeneration, or there might be other precursor cells in the pancreas. If these data are confirmed, this is a very provocative and remarkable finding,” Inverardi said.

The average hemoglobin A1C level dropped 1.06 percent for those with residual beta cell function and 1.68 percent for those without beta cell function. A1C levels measure average blood sugar levels over two to three months, and people with type 1 diabetes are advised to maintain A1C levels below 7 percent. A drop of 1 percent in A1C levels can reduce the risk of complications.

This was an initial clinical trial designed to test for safety. Zhao said that in future trials he hopes that with additional treatments people might get off insulin altogether.

But, even if that’s not possible, the recovery of some beta cell function would be welcome news. “In the absence of complete remission, there are very sizable advantages to having some beta cell function,” Inverardi noted.

Both experts said the treatment appears safe, with no risk of rejection. No significant side effects were reported during the trial, other than some arm soreness where blood was taken and returned.

Roche receives clearance from the U.S. Food and Drug Administration for the new Accu-Chek® Nano SmartView blood glucose monitoring system

Innovative, small, no code device will be available to people with diabetes in the U.S. in first half of 2012


 

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the

U.S. Food and Drug Administration (FDA) for its Accu-Chek® Nano SmartView blood glucose

monitoring system. The new Accu-Chek Nano meter, which is smaller than a standard credit card, employs a large brilliant backlit display and does not require any manual coding or code key for enhanced ease of use. It also offers improved functions such as customizable test reminders, preand postmeal markers and average glucose calculation. The Accu-Chek Nano meter uses Accu-Chek® SmartView test strips and will be available to customers in the first half of 2012.

 

“We are very excited to bring this latest blood glucose monitoring technology to the United States,”said Luc Vierstraete, Global Head of Roche Diabetes Care. “The Accu-Chek Nano meter is the newest advancement in Roche’s more than 35-year commitment to bring state-of-the-art innovations to people with diabetes and their caregivers, and continues our promise to enabling optimal diabetes management. This new system will help us to further leverage and enhance our position in this important market.”

According to the 2011 National Diabetes Fact Sheet published by the Centers for Diseases Control and Prevention, more than 25 million people in the US live with diabetes. However, seven million are currently undiagnosed and 1.9 million new cases of diabetes were diagnosed in people aged 20 years and older in 2010. It is also estimated that 79 million people live with pre-diabetes in the US.

“The Accu-Chek Nano blood glucose meter will appeal to those who prefer a small, discreet meter with maximum performance and is Roche Diabetes Care’s latest innovation aimed at enabling diabetes success for our customers and their health care team,” said Marc Gibeley, Head of Roche Diabetes Care North America. “It is easy-to-use and will help people with diabetes regularly check their blood glucose levels before making informed therapy and lifestyle adjustments. We look forward to its launch later this year.”

 

Roche Diabetes Care Roche Diagnostics GmbH

Sandhofer Straße 116

D – 68305 Mannheim

Global Communications Phone +49 621 759 9561

Fax +49 621 759789561

http://www.accu- chek.com

About the Accu-Chek Nano SmartView system

The Accu-Chek Nano SmartView blood glucose monitoring system offers a small, sleek and discreet design with easy-to-use operating buttons on top of the meter. It is the first single-strip no code meter in the Accu-Chek product family. This means it does not require any coding previously needed to calibrate the meter to the respective test strips and will use the maltose-independent Accu-Chek SmartView test strips. The Accu-Chek Nano SmartView system is part of the same product line as the Accu-Chek Aviva Nano and Accu-Chek Performa Nano systems that have already been launched successfully in many markets in the EMEA, Latin-American and APAC region.

 

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

 

About Roche Diabetes Care

Roche Diabetes Care is a pioneer in the development of blood glucose monitoring systems and a global leader for diabetes management systems and services. For more than 35 years, the Accu- Chek brand has been dedicated to enable people with diabetes to live life as normal and active as possible as well as to empower healthcare professionals manage their patients’ condition in an optimal way. Today, the Accu-Chek portfolio offers people with diabetes and healthcare professionals innovative products and impactful solutions for convenient, efficient and effective diabetes management. It encompasses blood glucose meters, insulin delivery systems, lancing devices, data management systems and education programs – contributing to an improved medical outcome. For more information: www.accu-chek.com.

 

For more information please contact

Ute Volkmann

Roche Diabetes Care

Todd Siesky

Roche Diabetes Care

Roche Diagnostics Roche Diagnostics

Phone: +49 621 759 9561 Phone: +1 317 521 3966

E-Mail: ute.volkmann@roche.com E-Mail: todd.siesky@roche.com

or visit

www.accu-chek.com

All trademarks used or mentioned in this release are protected by law.