Friday, February 5, 2010

“Insulin Study Could Lead to New Dosage Devices (New York Times)” plus 3 more

“Insulin Study Could Lead to New Dosage Devices (New York Times)” plus 3 more


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Insulin Study Could Lead to New Dosage Devices (New York Times)

Posted: 04 Feb 2010 10:06 PM PST

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The results of a new study on managing juvenile diabetes may give hope to millions of parents in this country and abroad who typically wake up several times a night to make sure their children's blood sugar levels have not dropped into the danger zone.

And the research, published Friday in The Lancet, a British medical journal, could help spur medical device companies to more quickly develop technology based on the study's underlying concept.

The study reported that a novel computer algorithm that analyzed children's glucose levels and recommended frequent adjustments in their insulin doses was better at preventing very low glucose overnight than a standard diabetes management system.

That standard system involved a continuous glucose monitor that operated separately from a preprogrammed insulin pump — an approach now used by many of the estimated three million people nationwide who have Type 1 diabetes. Type 1 diabetes, also known as juvenile diabetes, is a disease that often develops early in life and is separate from Type 2 diabetes, which often stems from obesity.

Very low glucose, called hypoglycemia, is a condition that poses risks for people with either form of diabetes, potentially causing shakiness, dizziness, seizures, coma or even death. But it is a particular concern among children on insulin because their blood sugar levels tend to fluctuate more widely, researchers said.

No children in the study who were treated with the computer-assisted system experienced very low blood sugar overnight. But there were nine instances of very low blood sugar among children who had the standard treatment, according to the study, conducted by researchers in Britain at the University of Cambridge.

"This is an important step in diabetes control because it shows that, with this system, people can sleep safely with minimized risk of hypoglycemia," said Dr. Eric Renard, a professor of diabetology at Montpellier University Hospital in Montpellier, France.

Dr. Renard, whose commentary accompanied the study in The Lancet, has been a consultant and speaker for several makers of diabetic products, he said.

Industry analysts have estimated that 10 to 15 percent of Americans with Type 1 diabetes — perhaps 400,000 of them — use either a continuous glucose monitor or an insulin pump, or in some cases both.

Over the last decade, the makers of medical devices have developed techniques that have widened diabetes management options beyond pricking the finger several times a day to test blood glucose levels. Companies like DexCom in San Diego now make small continuous glucose monitors whose sensors can be embedded in the skin. And Animas, a division of Johnson & Johnson, makes programmable pumps the size of a cellphone that administer insulin doses through a tiny implantable catheter.

These new-generation devices represent a significant advance over older products, said Aaron J. Kowalski, the assistant senior vice president of glucose control research at the Juvenile Diabetes Research Foundation in Manhattan, one of the largest nonprofit patient advocacy and research groups for diabetes.

Even so, Dr. Kowalski said, using separate devices that are not designed to work in concert poses limits to treatment, particularly overnight. If a diabetic person's blood sugar drops during the night and the glucose monitor alarm goes off, for example, that person may not wake up and the preprogrammed pump, operating separately, could continue to deliver insulin, making the problem worse, Dr. Kowalski said. (His group was one of the sponsors of the Lancet study.)

Researchers in Europe and the United States have been racing to develop a fully automated system for Type 1 diabetes that would wirelessly connect an external glucose monitor with an insulin delivery device. Based on algorithms like the ones used in the Lancet study, the devices would continually monitor glucose levels, calibrate insulin dosages and then dispense insulin in real time — automating a delivery task performed by a nurse in the study.

Researchers call such a hypothetical integrated system an "artificial pancreas" because it would mimic the way a healthy pancreas works, sensing glucose and dispensing insulin in the right dose at the right time. The goal is a portable system that could be worn on a belt and would be no larger than a cellphone.

Last month, as part of an effort called the Artificial Pancreas Project, the Juvenile Diabetes Research Foundation announced an $8 million partnership with Animas to develop a first-generation combined system. Meanwhile the European Union has just started its own project, called Artificial Pancreas at Home, which involves a grant of 10.5 million euros to research teams across Europe to create a prototype combined device over the next four years, Dr. Renard said.

The new study in The Lancet, proponents say, represents a proof-of-concept milestone in the quest to develop such a system.

"The significance is in showing that the existing devices, which are available commercially, can be combined to create the first version of an artificial pancreas," said Dr. Roman Hovorka, the lead author of the study.

Dr. Hovorka, a principal research associate in pediatrics at Cambridge, said he had been a consultant or speaker for several makers of diabetes products.

Although the Lancet study was small — only 17 children completed the entire protocol — it is significant because it demonstrated that a computer algorithm could safely interpret glucose data and calculate appropriate insulin doses for a pump, he said.

The study not only indicated that the algorithm system prevented very low glucose overnight, Dr. Hovorka said, but it also indicated that the experimental system was better able to keep blood glucose in an acceptable range.

After midnight, about 80 percent of the measured glucose levels fell in a target range in children treated with the computer-adjusted system — compared to only 35 percent in the target range for those treated with a standard preprogrammed pump system, according to the study.

Still, while the overall results were statistically significant, the study was not large enough to attain statistical significance in each of its separate arms. Those branches of the study examined how children fared after eating meals or after exercising — factors which can affect glucose levels.

And the experimental combined system itself was not fully automated. To ensure that the experimental algorithm did not recommend unsafe doses, a nurse read the computer-generated dosing suggestions and then adjusted the patients' insulin pumps.

Indeed, even if device makers are able to develop fully automated prototypes of combination systems, they are likely to face regulatory hurdles, analysts said, and would have to factor in product liability concerns.

"This is something that companies have been striving to do for years, and as computer chip technology evolves, it gets closer," said Rick Wise, an analyst at Leerink Swann, a health care investment bank. "But you have to appreciate how exquisitely reliable an artificial pancreas would have to be to read glucose correctly and dispense insulin correctly."

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Village Seeks Dissolution Study (East Aurora Advertiser)

Posted: 05 Feb 2010 05:14 PM PST

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Wales Looks at Ways to Abolish Tax Post
Under a proposal put forth by Wales Town Councilman Donald Butcher, the office of receiver of taxes would be abolished and melded into Town Clerk Sharon Marfurt's department.

West Declares Candidacy for Village Board
Randy West of East Aurora announced on Monday that he will seek a post as village trustee. West, an engineer and an eight-year member of the Village Planning Commission, indicated that he seeks to bring his experience and expertise to serious issues facing the village.

A Classic Winter Week in East Aurora
"Snow is free." That is what Brian P. Higgins—not the congressman—said while talking about the snow sculptures he creates within the village with three generations of family members every year. His outlook on the cost of snow makes winter seem like a gift.

Village Seeks Dissolution Study
The Village of East Aurora will seek a $50,000 state grant to fund a study that will examine the feasibility of dissolving the village government. Though some trustees had earlier opposed such a study, the six members of the board present at a Feb. 1 work session agreed to apply for the study as part of a three-pronged approach suggested by Deputy Mayor Libby Weberg. Her suggestions, and the board approval, follow a Jan. 20 New York State Conference of Mayors and Municipal Officials (NYCOM) forum in Orchard Park at which NYCOM representatives stressed the time constraints on a potential referendum to dissolve the village, as well as the high level of competition for dissolution study grants.

Man Charged with DWI Tried to Flee Troopers
A 25-year-old Blasdell man was arrested on charges of driving while intoxicated, resisting arrest and unlawful possession of marijuana following a Monday-night traffic stop for speeding on Transit Road in the Town of Elma. The man allegedly attempted to flee State Police after being told he was under arrest for driving while intoxicated.

Deputies Make Reckless Driving Arrest in Holland
Deputies Chris Parisi and Don Hoelscher arrested a 32-year-old Holland man Jan. 30 after investigating a citizen complaint on North Canada Street. The man had allegedly driven his vehicle dangerously close to a resident. He was charged with reckless driving, aggravated unlicensed operation, operating with a suspended registration, driving without a license and failure to keep right. He was also wanted on an arrest warrant for driving while intoxicated by the Village of Depew. Deputies transported the man to the Erie County Holding Center to await arraignment on his charges in Holland Town Court.

Wales Kiwanians Plan "Souper Bowl" Event
The Wales Kiwanis Club will again be holding its popular "Souper Bowl Sunday" fundraiser on Sun., Feb. 7 from 12 to 2 p.m. at the Wales Center Fire Hall on Route 20A. The event coincides with the NFL Super Bowl game between the New Orleans Saints and Indianapolis Colts later than day.

Farm Bureau Recognizes Officials
New York Farm Bureau, the state's largest general farm advocacy organization, has named 84 state legislators to its Circle of Friends for the year 2009. The award is an indication of each individual lawmaker's support of New York agriculture and the Farm Bureau.

Pathways Christian Fellowship and Local Residents to Assist in Gulf Coast Rebuilding Efforts
Pathways Christian Fellowship of South Wales is sponsoring a trip to help rebuild hurricane- and flood-damaged homes in southeast Louisiana.

Bachman Wins Middle School Geography Bee
East Aurora Middle School fifth-grader Benjamin Bachman was the winner of the school's 2010 National Geography Bee. The runner-up was Tanner Reese, an eighth-grader.

Committee Members Sought for Elma Day
The Elma Town Board is looking for people interested in volunteering for a citizens' committee to help organize and coordinate "Elma Day." The June 13 event will feature a car show and a ceremonial disposal of American flags.

Unshackle Upstate Leader Coming to East Aurora
The Greater East Aurora Chamber of Commerce will be hosting a presentation by Unshackle Upstate Executive Director Brian Sampson on Wed., Feb. 3 at 6 p.m. in the auditorium at 300 Gleed Ave.

Wales Makes 2010 Appointments
The Wales Town Board made appointments to various town advisory committees and posts at its re-organizational meeting Jan. 12. Councilman Gerald E. Klinck, named as deputy supervisor, will also serve as the town's delegate to the Northeast Solid Waste Team (NEST). The organization is responsible for the overall recycling and refuse efforts in this part of Erie County. Klinck also will serve as chairman of the town's solid waste, conservation, soil and water committee.

Marilla Club Celebrates 95th Anniversary of Kiwanis
The Kiwanis Club of Marilla celebrated with Kiwanians Worldwide as the organization marked its 95th birthday on Jan. 21. Marilla Town Historian Hubert Kutter, a Marilla Kiwanian, gave a presentation to the club at the local meeting on that day, speaking about the changes in the world since that first meeting.

Community Members Invited to Toastmasters Event
On Mon., Feb. 1st, professional speaker, author, and Past Toastmasters International Director, Gary Mull, will be presenting "Be An Exceptional Presenter - 5 Key Techniques to Sharpen Your Skills."

Classes Aimed at Needs of Single Parents
Single parents interested in learning about food budgeting, meal planning, dealing with home emergencies, home repair, health and other topics are invited to attend one or more workshops in a series hosted by Pathways Christian Fellowship.

Town Board to Discuss Joint Facility Feb. 16
At its 7 p.m. work session on Feb. 16, the Aurora Town Board will discuss the final report from a study on the possibility of creating a joint village/town/library facility. The study was made possible by a Shared Municipal Services Incentive (SMSI) grant from New York State. Town Supervisor Jolene Jeffe said that the board members had recently received the final report, but that they should have time to review it before the work session. Town Engineer Bryan Smith noted that the study had only a few differences from the draft presented in October 2009. The new report will be available for review by citizens at Town Hall.

Holland School OKs Budget, Teachers' Contract
A round of applause followed the Holland Central School Board's approval Jan. 25 of a new teachers' contract, 18 months after the previous one expired. Following months in which no negotiations took place, the administration and teacher's union hammered out a deal during one afternoon.

Judicial Race had the Highest Spending of 2009
This is the third article in a series analyzing the 2009 elections in the Town of Aurora.

EA Students Prepare for "Annie"
Little Orphan Annie, Daddy Warbucks, and yes, even Sandy, will take the stage when East Aurora High School presents "Annie" on Feb. 5, 6, and 7. Over 125 students are part of the production, based on the iconic musical that debuted at the former Alvin Theatre in New York nearly 33 years ago.

Workshop Series to Start at East Aurora UU Church
"Woman attacked and stabbed in eye after leaving lesbian nightclub." "Man beaten in mall parking lot by attackers shouting gay slurs." These two local headlines gave a grim start to 2010 in Western New York. Hate crimes persist in our midst; most of them do not make headlines. They happen around the world, across our country, and in our own backyard. Some locals are doing what they can to turn the tide, to promote compassion for all people – but in particular, to make a deliberate effort to better understand the gay/lesbian/bisexual/transgender (GLBT) community, and the obstacles they face.

Hartwick Still Unaccounted For
As of Tues., Jan. 26 Lynn University had no new information on Dr. Patrick Hartwick, a former East Aurora resident who was in Port-au-Prince, Haiti, on Jan. 12 when an earthquake struck there. Hartwick is believed to have been in the fitness center of the Hotel Montana when the hotel collapsed. He, another professor and four students were part of a Lynn University group visiting the country as part of a program called "Journey of Hope to Haiti."

Relay for Life Effort will Kick Off February 6th
All are invited to the eighth annual Kick Off for this year's Elma Relay For Life, which will benefit the American Cancer Society.

Colern Asks Elma to Change Inspection Fees
Building Inspector Joseph Colern spoke to the Elma Town Board at a work session on Jan. 13 about the possibility of changing the fee schedule for fire inspections for commercial businesses in town. Colern said he would like to update the "archaic" pay structure to make the work a little easier for his department and give businesses an exact figure on what they would be charged.

Butcher Renews Call to Eliminate Wales Tax Post
Councilman Donald Butcher has asked the Wales Town Board to abolish the office of receiver of taxes and consolidate it into Town Clerk Sharon Marfurt's office in an attempt to save the town money. Speaking at the board's Jan. 12 meeting, Butcher said the opportunity to streamline the local government presented itself when former Tax Collector Shirley Schiltz voluntarily retired at the end of last year, leaving the elected position vacant.

Aurora Board Makes 2010 Appointments, Policies
At its first meeting of 2010, held Jan. 11, the Aurora Town Board approved the town's new organizational chart, making personnel appointments, setting salaries and approving official business relationships. As reported last week, Town Supervisor Jolene Jeffe named Councilman Jeffrey Harris as deputy supervisor and Lisa Hoffman as secretary to the supervisor.

Travel Information

Travel Info Links
Here are handy links to weather, highway conditions, airports.

February study skill workshops in Florham Park (Florham Park Eagle)

Posted: 05 Feb 2010 04:54 AM PST

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FLORHAM PARK - KnowledgePoints Tutoring, with locations at the Regency Plaza at 186 Columbia Turnpike and Life Time Athletic at 14 Fernwood Road, both in Florham Park, will offer two study skills workshops for middle and high school students through the Adult School of the Chathams, Madison and Florham Park.

Study Suggests Slide-On® EndoSheath® System Provides Several Advantages over Traditional Germicidal Immersion (Business Wire via Yahoo! Finance)

Posted: 05 Feb 2010 06:00 AM PST

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MINNEAPOLIS--(BUSINESS WIRE)--Results of a clinical study presented Thursday, Feb. 4 at the annual Triological Society meetings in Orlando, Fla., suggest a sterile barrier sheath system has distinct advantages over germicidal immersion processes used to prevent contamination of fiberoptic nasopharyngolaryngoscopes (flexible ENT scopes). Flexible ENT scopes are used by otolaryngologists to examine the nose and throat area for various disorders such as dysphagia, reflux disease, snoring, and chronic sinusitis.

Microbial study results show that sterile disposable sheaths, when used with endoscopes, are as effective as using a liquid germicidal system for disinfecting scopes between patient procedures and provide protection against cross-contamination equivalent to immersion in germicidal solutions.

Study authors Alphi Elackattu, MD; Mary Zoccoli, MD; Jeffrey H. Spiegel, MD, FACS; and Kenneth M. Grundfast, MD, FACS, all from Boston University School of Medicine, note in their conclusion that through the use of sterile disposable sheaths, physicians will be able to prevent cross-contamination. Using the individually packaged disposable sterile sheaths has been cleared by the U.S. Food and Drug Administration as an acceptable alternative to high level disinfection following endoscope use.

The Medtronic Slide-On™ EndoSheath® System is a sterile, disposable cover for flexible endoscopes that provides a latex-free barrier between the scope and the patient. The system is designed to reduce patient contact with organic debris and staff exposure to hazardous chemicals. The study authors noted that the system is an alternative to time-intensive chemical reprocessing, allows for quick scope turnaround and helps physicians maximize time treating patients.

"The EndoSheath System is designed to allow physicians to cover the insertion tube of the flexible ENT scope with a sterile microbial barrier when performing endoscopy procedures in the clinic and office environments," said Janis Saunier, marketing director for the ENT division at Medtronic. "We believe the use of a sterile sheath on a nasopharyngoscope, combined with enzymatic detergent cleaning and disinfection with 70 percent alcohol, can provide a reliably decontaminated, patient-ready instrument, providing an acceptable alternative to high-level disinfection of endoscopes."

About the ENT Business at Medtronic
Located in Jacksonville, Florida, the Ear Nose and Throat (ENT) division at Medtronic develops and manufactures products designed to treat ENT diseases. As the market leader in ENT, Medtronic is changing the way ENT surgery is performed with innovative, minimally invasive products and techniques that benefit both patients and surgeons. Main products include powered tissue-removal systems and other microendoscopy instruments, nerve monitoring systems, sleep-disordered breathing therapies, image-guided surgery systems, disposable fluid control products, and a Ménière's disease therapy device. Learn more about the ENT business on the web at www.MedtronicENT.com

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 24, 2009. Actual results may differ materially from anticipated results.

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