July 29, 2009 (Newswise) - The Centers for Disease Control and Prevention (CDC) this week held an inaugural conference on obesity prevention and control. The CDC's Division of Nutrition, Physical Activity, and Obesity convened in Washington, D.C. to chart ways to improve access to healthy places, discuss opportunities for obesity prevention, and plan physical education standards in schools through federal policy.Obesity is a risk factor for a number of chronic diseases, including diabetes, heart problems, osteoarthritis, and sleep apnea. Furthermore, the health cost of obesity in the U.S. could be as high as $147 billion annually, according to a study from Research Triangle Institute and the Centers for Disease Control and Prevention.

Regular time in nature is a critical tool that can be used to prevent obesity and encourage physical activity, at no cost. Getting kids outdoors can improve our nation's physical and mental health. Kids who spend time outdoors reap the benefits of greater school readiness, creativity, self-sufficiency, and confidence.

Kevin Coyle, National Wildlife Federation's Vice President for Education and Training, said today:

"To raise a healthier generation and implement effective federal obesity prevention legislation-it takes a range of strategies including outdoor time. National Wildlife Federation applauds the CDC's inaugural Weight of the Nation conference, an effort to combat obesity in adults and prevent it in future generations.

"To support these efforts, the Federation has developed a Be Out There parent education program which includes its Green Hour Activities Guides-designed to help parents and children get an hour per day-whenever possible-of outdoor time. The NWF Green Hour is in keeping with the CDC policy for children to have an hour per day of light to moderate physical activity daily to control obesity.

"Today's children have less contact with nature and outdoor play than any generation in human history. They are spending on average 44 and one half hours a week in front of a screen: watching television, surfing the internet, and playing video games, the equivalent of a full-time work week. This 'indoor childhood' has significant implications for our children's mental and physical health.

"Outdoor play is key to the intellectual, emotional, and physical health of our children. Providing them with quality opportunities to directly experience the natural world improves students' overall readiness to learn, as well as aids health, self-esteem, personal responsibility, community involvement and understanding of nature."

July 28, 2009 (BusinessWire) - Elron Electronic Industries Ltd. (NASDAQ & TASE: ELRN) announced today, that further to it previous announcement on July 28, 2009, Medingo Ltd., a group company held 92% by Elron and its subsidiary, RDC - Rafael Development Corporation Ltd., has received formal clearance from the Food and Drug Administration ("FDA"), to market its Soloâ„¢ MicroPump Insulin Delivery System in the United States.Medingo intends to introduce the Soloâ„¢ MicroPump at the American Association of Diabetes Educators Meeting which will take place in August 2009 in Atlanta, U.S.A.

"We are very excited to have received FDA clearance for Medingo's innovative, miniature, tube-free, insulin delivery system," commented Arie Mientkavich, Chairman of Medingo and Elron. "This is a major milestone for Medingo, which will enable it to progress to the next phase in its development. Medingo is currently considering alternatives for its go-to-market strategy and the timing of the product launch."

May 8, 2009 (AACE) - New recommendations released today by a consensus group of the American Association of Clinical Endocrinologists (AACE) and the American Diabetes Association (ADA) are calling for major changes in the way health care professionals treat hospitalized patients with high blood glucose (sugar) levels. The authors recommend revised glucose targets of 140-180 mg/dL in the ICU setting, and between 100-180 mg/dL for most patients admitted to general medical-surgical wards.The recommendations, which were published online today and will appear in the June issues of Endocrine Practice and Diabetes Care, come at a time when attempts to intensively manage glucose targets in the ICU setting have shown inconsistent results in patient outcomes. Several recent randomized controlled clinical trials in critically ill patients in ICUs with diabetes or elevated blood glucose levels have failed to show a significant improvement in mortality with intensive insulin therapy to achieve near normal glucose levels. Moreover, a large newly-published randomized controlled trial showed an increase in mortality risk associated with intensive control of glycemia targeting blood glucose of 80-110 mg/dL. These outcomes have raised concerns regarding specific glycemic targets and the means for achieving them in both critically and non-critically ill patients.

Recognizing the importance of glycemic control across the continuum of care, experts from AACE and ADA were invited to develop an updated consensus statement on inpatient glycemic management.

After a thorough analysis of all the published trials, the authors believe that patients with elevations in blood glucose should continue to be carefully treated, but to less intensive blood glucose targets than were previously suggested. The authors recommend revised glucose targets of 140-180 mg/dL for critically ill patients in ICU settings.

"We are witnessing an evolution in the management of hyperglycemia in inpatient settings," Dr. Etie S. Moghissi, AACE Chair of the Inpatient Glycemic Control Consensus Panel said. "Despite some inconsistencies in the clinical trial results, it would be a serious error to conclude that judicious control of glycemia in hospitalized patients is not warranted."

The complexity of inpatient glycemic management necessitates a system approach that facilitates safe practices that reduce the risk for errors and episodes of severe hypoglycemia. The consensus group recommends a multidisciplinary approach for care from admission to discharge from the hospital.

"The responsibility for management of hyperglycemia shifts from the health care team to the patient following hospital discharge," said Dr. Mary Korytkowski, ADA Chair of the Inpatient Glycemic Control Consensus Panel. "It is therefore important that patients receive the information necessary to safely manage this aspect of their care once they are at home."

April 30, 2009 (FDA.gov) - This notification applies to all ACCU-CHEK® Spirit insulin pumps with serial numbers from SN02119552 through SN10006093 (range of SN shipped to the US). Pumps with serial numbers including and above SN10006094 are not affected and no action is required by users of these pumps.Disetronic Medical Systems Inc. announced today that it is notifying its customers, distributors and healthcare professionals about a potential defect in the "up" and/or "down" buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the "up" and/or "down" buttons. The pump's "up" and "down" buttons are used for changing the program in the menu or to administer additional insulin through a bolus delivery. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. This defect was discovered through the company's normal quality control monitoring process.

The notifications provide specific actions and details that customers, distributors and healthcare professionals need to take. The pumps in question have serial numbers in the range from SN02119552 through SN10006093 (US market).

If the vibration or acoustic confirmation signal does not occur, the user should disconnect the pump, and switch to a back up pump or an alternative method of insulin delivery. Immediately contact ACCU-CHEK Spirit hotline for a replacement pump or for any other questions regarding this potential defect. Customers should expect the replacement pump within 1-2 business days after contacting ACCU-CHEK Spirit hotline at 1-800-778-5095. This number is available 24 hours a day, 7 days a week.

Disetronic will replace pumps within the affected serial numbers (SN02119552 to SN10006093) that have intermittent or complete loss of function of the "up" and/or "down" button promptly upon contact from the customer with a new pump that is not affected by the potential button failure. If you have any questions regarding this recall or questions pertaining to replacement, please contact ACCU-CHEK Spirit hotline at 1-800-778-5095 for further information. This number is available 24 hours a day, 7 days a week.

"We are making this proactive notification to our customers and other interested parties because we have seen a potential for the "up" and/or "down" buttons on some of our pumps to fail over a period of use," said Dr. Mathias Neumann, Head of Global Quality Management Diabetes Care, Roche Diagnostics. "We are telling our customers to continue to use their ACCU-CHEK Spirit insulin pumps, but monitor the functioning of the "up" and "down" buttons. In addition customers are to continue to monitor their blood glucose as directed by their healthcare professional. Additional actions required by customers are detailed in their notification. We are working with the Food and Drug Administration (FDA), who is aware of this recall and this notification.

We have isolated the root cause of the defect and a fix to the problem has been implemented with SN10006094 and above," said Dr. Neumann. "The problem is an interrupted electronic contact in the flexible board of the "up" and "down" button module caused over time by stress of this board during repeated pressing of the button."

Users of an ACCU-CHEK Spirit insulin pump, who are experiencing failure of the "up" and/or "down" buttons, should immediately contact ACCU-CHEK Spirit hotline at 1-800-778-5095. This number is available 24 hours a day, 7 days a week.

March 25, 2009 (BusinessWire) - Smiths Medical announced today its intent to stop selling the Deltec Cozmo® insulin pump, and manage an orderly, carefully controlled exit from the diabetes business over time."The continued health of the thousands of people who use the Deltec Cozmo® insulin pump is our primary concern, and they should be reassured that their pump remains an excellent choice to help them manage their diabetes," said Srini Seshadri, president of Smiths Medical. "Our customers also should be reassured that Smiths Medical will meet all of its warranty obligations; provide customer and clinical support for the lifetime of the warranty of all pumps; ensure that Deltec Cozmo® insulin pump cartridges and Cleo® and Comfort® infusion sets are available; and make any necessary transitions as simple as possible."

For people with a Deltec Cozmo® insulin pump, today's announcement means two important things:

When the pump approaches the end of its warranty period, customers should consult with their healthcare provider to choose a pump from another manufacturer.

Smiths Medical will work with pump users to transfer purchases of cartridges and infusion sets to one of the many national and/or regional distributors that stock these items. (Anyone who already is familiar with a distributor should feel free to contact that company immediately and start ordering supplies directly.)

NOTE: Pump users outside of the United States may continue to purchase disposable cartridges and infusion sets from their local Smiths Medical distributor, a list of which can be found at www.DeltecCozmoUpdate.com.

For more information, including distributor contact details, U.S. and International pump users and healthcare professionals should visit www.DeltecCozmoUpdate.com. In the United States, people may also contact the Smiths Medical customer support team at 1-800-826-9703.

Why Smiths Medical Made This Decision

Smiths Medical considered many possible options to create a long-term, sustainable diabetes business. However, after reviewing these options, it was decided that the best course of action is to exit the diabetes market.

In addition, as its only direct-to-consumer enterprise, the Diabetes business has little synergy with the rest of Smiths Medical's businesses. For this reason, Diabetes requires its own extensive sales, marketing, reimbursement, insurance and clinical support infrastructure in the United States, which has resulted in it becoming uneconomical as sales and profits for the business have decreased. Without a strong, profitable Diabetes business in the United States, the world's largest medical market, it would also be impossible to sustain the business internationally.

Finally, dramatic changes have taken place in the diabetes market during the past three years, including:

The market has evolved from a familiar hardware-plus-disposables model to an integrated diabetes management model that would require significant ongoing investments in continuous glucose monitoring.

Smiths Medical's shrinking market share has been exacerbated by the aggressive pursuit of market share growth by two large and well-resourced players - Medtronic, which has the largest share of the U.S. insulin-pump therapy market, and J&J.

A considerable amount of intellectual property has been established in the diabetes segment, which makes the development of next-generation products very costly, and risky in terms of the potential for future patent disputes.

"Throughout our involvement in the diabetes market, we have chosen always to put care for our customer first, providing excellent clinical support, maintaining the integrity of our warranty and being proactive about fixing issues as they arose," said Seshadri. "For our efforts, we have been rewarded with a core group of very loyal customers. We thank them and reiterate our commitment to making this transition as easy as possible for them."

March 25, 2009 (EurekAlert) - The journal Biochemical and Biophysical Research Communications (BBRC), published by Elsevier, will publish an important review this week online, by M. Daniel Lane and colleagues at Johns Hopkins, building on the suggested link between the consumption of fructose and increased food intake, which may contribute to a high incidence of obesity and Type 2 diabetes.Over the past four decades life-styles have gravitated toward the excessive consumption of 'high energy' foods and sedentary behavior that has resulted in a high incidence of obesity and its pathological consequences. This scenario has led to the increased occurrence of insulin resistance and Type 2 diabetes. At present, approximately thirty percent of adult Americans can be classified as obese. Moreover, these changes now extend into the younger age group.

M. Daniel Lane and co-workers at The Johns Hopkins University School of Medicine in Baltimore have now pulled together work, largely in their laboratory (many papers beginning in 2000), dealing with the role of malonyl-CoA in the signaling system in the brain (specifically the hypothalamus) that has inputs into the higher brain centers that determine feeding behavior, most notably appetite. Two papers in the journal PNAS in 2007 and 2008 showed that glucose and fructose act quite differently in the brain (hypothalamus) - glucose decreasing food intake and fructose increasing food intake. Both of these sugars signal in the brain through the malonyl-CoA signaling pathway and have inverse effects on food intake.

Lane commented: "We feel that these findings may have particular relevance to the massive increase in the use of high fructose sweeteners (both high fructose corn syrup and table sugar) in virtually all sweetened foods, most notably soft drinks. The per capita consumption of these sweeteners in the USA is about 145 lbs/year and is probably much higher in teenagers/youth that have a high level of consumption of soft drinks. There is a large literature now that correlates, but does not prove that a culprit in the rise of teenage obesity may be fructose."

The fact that fructose metabolism by the brain increases food intake and obesity risk raises health concerns in view of the large and increasing per capita consumption of high fructose sweeteners, especially by youth.

July 1, 2008 (Press Release) - Animas Corporation announced today the clearance of its OneTouch ® Ping TM Glucose Management System by the U.S. Food and Drug Administration (FDA). OneTouch Ping is the first full-feature insulin pump that wirelessly communicates with a blood glucose meter-remote. Using the OneTouch Ping meter-remote, a person can calculate insulin doses and opt to wirelessly instruct the pump to deliver them without touching the pump at all, giving patients more freedom and flexibility in using their insulin pump. "OneTouch Ping provides patients the advanced insulin pump technology from Animas plus the OneTouch blood glucose technology they trust, put together into a system that offers the discretion, convenience and option of remote insulin dosing," said Juan Frias, M.D., Chief Medical Officer and Vice President of Medical Affairs, Animas Corporation. "People using OneTouch Ping will no longer have to access their pump to deliver a bolus, ultimately making life with diabetes a little easier."

OneTouch Ping also marks the first integrated product from two companies within the diabetes care group of Johnson & Johnson, Animas makers of insulin pumps and LifeScan makers of the OneTouch brand of glucose meters and OneTouch® Ultra® Test Strips.

OneTouch Ping also offers the following:

• Lifestyle-focused pump performance - the pump can be clipped to a belt, tucked in a pocket, or secured under clothing, is waterproof up to 12 feet for 24 hours and has a color screen for outstanding pump readability
• Individualized control - delivers lowest basal increments (0.025 U/hr) and lowest bolus increments (0.05 U) available to more precisely match patient insulin needs
• Proven blood glucose monitoring technology - the meter-remote utilizes OneTouch Ultra Test Strips, the leading brand of test strips covered by more health plans at the lowest co-pay

ezManager® MAX Diabetes Management Software
The OneTouch Ping system will also work with the recently cleared ezManager® MAX Diabetes Management Software designed to allow users to download important diabetes management data from the insulin pump and meter-remote. Integrated blood glucose data from the meter-remote and insulin dosing data may be downloaded for review, analysis and evaluation of insulin delivery and blood glucose history to better inform healthcare decision-making. The ezManager® MAX software is MAC and PC compatible.

OneTouch Ping will be available for shipment in mid-August 2008. Customers can order at any time by calling 1-877-937-7867 or visit www.animascorp.com.

July 1, 2008 (EurekAlert) - A study by researchers at the Joslin Diabetes Center has shown that adherence to prescribed dietary recommendations is associated with better glucose control in children with type 1 diabetes.

"In recent years, diabetes management has been focused around new medications and technologies," said Lori Laffel, M.D., senior author of the paper, which is published in the July issue of Diabetes Care. "In this study, we were encouraged to identify the unique importance of diet on blood sugar control in children and teens with type 1 diabetes."Laffel is Chief of Joslin Diabetes Center's Pediatric, Adolescent and Young Adult Section and an Investigator in the Joslin Section on Genetics and Epidemiology.

The study surveyed the parents of 119 children and teens ages 9-14 years and asked how closely they followed prescribed dietary behaviors, such as estimating carbohydrate intake, matching the child's insulin dose to carbohydrate intake and the quality of the diet itself, in terms of intake of sweets and fats.

Subjects who most closely adhered to the dietary recommendations had lower A1C levels - a measurement of average blood glucose deemed the best way to estimate overall glucose control. Lower A1C levels mean better glucose control.

Children who adhered closely or fairly closely to the prescribed dietary recommendations showed an A1C level of up to almost a full point lower than those who were least adherent. Those who adhered the least had an average A1C of 9 percent, while those who adhered more closely to the recommendations had an average A1C between 8.1 and 8.4 percent, depending on their level of adherence.

The A1C difference of between 0.6 and 0.9 is considered significant, according to Sanjeev Mehta, M.D., lead author and a Joslin staff physician and research associate, who noted that lowering A1C scores is associated with a significant reduction in risk of diabetes-related complications.

"By achieving target A1C levels, the long-term risk of complications can be reduced by 50 to 75 percent," he said. "For every point you lower your A1C score, the risk is reduced further."

Mehta said the study's demonstration that dietary behaviors are directly associated with glycemic control provides families with another avenue through which they can optimize their children's diabetes management. He noted that this study highlights the importance of dietary adherence in achieving optimal glucose control in the era where more youth with type 1 diabetes are using new technologies, such as insulin pumps and rapid acting insulin.

"The relative importance of dietary behaviors in diabetes management had not been investigated in this current era," he said.

The paper concluded: "Dietary adherence may represent an important modifiable factor in the treatment of youth with type 1 diabetes. In this era of intensive management, future interventions aimed at increasing diabetes-specific dietary adherence may improve glycemic control in this population."

June 26, 2008 (Newswise) - The Centers for Disease Control and Prevention recently reported that the number of Americans with diabetes has grown to 24 million - a surge of more than 3 million people in the past two years.

That surge is evident at Temple University's School of Podiatric Medicine, where podiatrists have seen a spike in recently diagnosed diabetic patients who have been referred by their primary care physician as part of a heightened awareness of the disease."Diabetes has reached epidemic proportions, and health care providers are becoming more proactive in their approach to care," said Temple podiatrist Kathya Zinszer, who specializes in diabetic wound care. "In years past, patients would come to their doctor with chronic foot wounds, and would be so far gone that the only option would be to amputate. Now, that's not the case, thanks to the push for preventative care."

Temple's approach to preventative care is two fold: at the Foot and Ankle Institute, newly diagnosed diabetics undergo a number of baseline tests including shoe fittings and gait analysis, to determine and correct any problem areas before they develop into chronic ulcers or wounds.

In addition, Zinszer and her colleagues stress the need for patients to make foot care a part of their everyday lives. She suggests wearing good, supportive slippers in the house, never going barefoot outdoors and checking inside the shoes to make sure there are no foreign objects that could rub or cut the foot.

"I tell all my patients to get in the habit of checking their shoes now, because while they may have good feeling in their feet today, in 10 years, they might not," said Zinszer.

"Our goal is to do everything we can to salvage limbs and help our diabetic patients maintain a good quality of life," she said.

June 25, 2008 (Newswise) - Efforts to make diabetes care more manageable, and easier on the patient, have led to the introduction of insulin "analogs" - medicines that act similarly to ordinary insulin, but which are supposed to provide additional benefits. Recent research from Generex Biotechnology, a company focused on advanced insulin delivery and diabetes vaccine research, shows that the advantages of insulin analogs may be illusory. Investigators from the company presented their data at the recently completed Endocrine Society 90th Annual Meeting, held in San Francisco from June 15 through 18. The presentation was co-authored by researchers from the Institute for Endocrinology IEMYR, Quito, Ecuador, and the University of Florida, Gainsville.The year-long study examined 26 subjects with type 1 diabetes, which is normally treated with "basal" injected injection once or twice a day to provide baseline glycemic control, and additional insulin injections before meals. The control study group received insulin glargine (an insulin analog) once a day as their basal dose, and a faster-acting insulin analog before meals. The treatment group received a non-analog long-acting insulin twice a day as their basal insulin; before meals the they took Oral-lynâ„¢, a liquid formulation of human insulin, developed by Generex, that is absorbed through the lining of the mouth. All subjects were monitored for three standard measures of glycemic control: Hemoglobin A1c and fructosamine levels were recorded every two weeks by investigators, and pre-meal glucose levels were taken by patients themselves. Together, these readings assess the effectiveness of diabetes treatment regimens better than any test alone. Higher readings generally indicate less-effective glucose control.

At the end of the study all three measures were found to be consistently and significantly lower in the group that received the human insulin regimen that included the Oral-lyn product before meals. Oral-lyn uses a formulation that allows insulin to pass through the "buccal" mucosa - the soft tissues lining the inside of the mouth - and into the bloodstream rapidly and safely, without injection. Oral-lyn is delivered to the mouth using Generex's proprietary RapidMistâ„¢ spray device. Unlike inhaled insulin products which have enjoyed limited success, the combination of Oral-lyn insulin and RapidMist delivery technology allows patients to deliver their insulin dose as needed, and do not deposit insulin into the lungs.

People with diabetes, and physicians treating them, have become excited in recent years by insulin analogs due to their rapid window of action. Several studies have also claimed that analogs improve glycemic control. Insulin analogs can cost up to three times as much as insulin, however, which can place serious financial strains on families that pay for their own insulin. Even families with comprehensive drug coverage will find that plans charge a significantly higher co-pay for insulin analogs than for "regular" human insulin.

"Our results clearly show that over the course of a year-long study the advantage of these analogues is equaled or improved upon by the use of Oral-lyn. When Oral-lyn is absorbed through the buccal mucosa its rapid entry into the blood stream mimics and improves upon the rapid acting analogues." commented Dr. Jaime Guevara, a study author and clinician that has conducted studies for Generex's Oral-lyn. "Claims that analogs provide superior convenience do have some merit when these agents are compared with insulin injected before meals. However, when compared with Oral-lyn, which is not injected, even those arguments fail to make the case for drugs that cost three times as much as standard insulin."

Oral-lyn is currently approved in two countries, and is currently undergoing clinical testing for U.S. approval.

For more information, log on to http://www.generex.com