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Scientists getting closer to artificial pancreas

Posted: 24 Jun 2011 08:45 PM PDT

CHICAGO (Reuters) - Researchers are coming closer to developing an "artificial pancreas," a long-sought system of insulin pumps and glucose sensors that deliver insulin to diabetics, mimicking the function of a real pancreas.

A laboratory technician tests fluids at the Institute of Cellular Medicine, in San Jose, May 18, 2010. (REUTERS/Juan Carlos Ulate/Files)

The devices have been in development for more than three decades, but lawmakers and diabetes advocates are ramping up the pressure and U.S. regulators this week outlined a regulatory path for a preliminary version of the device.

And while a seamless device that tracks a diabetic's blood sugar and automatically administers the right dose of insulin is still years away from commercial use, results of several studies being presented this week at the American Diabetes Association meeting in San Diego show real promise.

In one, researchers from Boston University and Massachusetts General Hospital tested a system using Abbott Laboratories' FreeStyle Navigator continuous glucose monitor and two insulin pumps made by Insulet Corp, all controlled by a laptop.

The system, which is designed to better mimic the body's natural mechanism of controlling both high and low blood sugar, was portable enough to allow adults with type 1 diabetes to roam around a hospital and use an exercise bike.

At the end of the 51-hour study, which involved daily exercise, two nights and six meals -- all of which affect a diabetic's blood sugar levels -- six patients had an average blood glucose in the normal range -- in the high 140s, which is about the equivalent of an A1c reading of about 7.

"It is very good. This is what we would call near normal blood glucose," said Dr. Steven Russell of Massachusetts General Hospital in Boston who is developing the system with Edward Damiano, a biomedical engineer at Boston University.

In another study, a team at Mayo Clinic hooked patients up with devices called accelerometers that tracked movements and found that even moderate exercise plays a role in glucose. The team, led by Yogish Kudva, will incorporate this data into a sophisticated software program that acts as the "brain" of an artificial pancreas system, analyzing blood sugar and calculating when diabetics need a dose of insulin.

The team plans to start a clinical trial with the system this year or early next year, Kudva says.

CLOSING THE LOOP

So-called closed-loop systems -- in which a computer calculates a person's insulin dose and delivers insulin automatically through an insulin pump -- are a far cry from the earliest version of an artificial pancreas developed in the late 1970s, says Dr. Aaron Kowalski of the Juvenile Diabetes Research Foundation or JDRF.

"The problem is it was the size of a refrigerator," said Kowalski, who oversees the group's Artificial Pancreas Project, a multimillion-dollar initiative aimed at accelerating progress toward a closed-loop automated insulin-delivery system .

With that device, patients were hooked up to an IV and could not leave their hospital bed.

Researchers have since been working to develop a so-called artificial pancreas to deliver insulin to patients with type 1 diabetes, an autoimmune disease in which the body destroys its own ability to make insulin, rendering sufferers unable to properly break down sugar.

People with the condition must frequently monitor and take insulin to regulate blood sugar and prevent diabetic complications such as eye damage, kidney failure and heart disease.

An estimated 3 million Americans have type 1 diabetes, usually diagnosed in childhood or in young adults.

The JDRF is working with Johnson & Johnson's Animas unit, which makes insulin pumps, and DexCom Inc, which makes continuous glucose monitoring devices.

Kowalski said nearly five years into the project, researchers are showing promising results, but he is frustrated with the pace of progress.

"People need better tools. Despite insulin pumps and continuous glucose monitors, there are still big challenges in diabetes management," Kowalski said.

The group on Wednesday urged a Senate hearing to call on the FDA to stop delaying the study and approval of an artificial pancreas.

They cited a study published in the British Medical Journal that found that if an artificial pancreas were available, Medicare would save nearly $2 billion over 25 years in costs related to diabetes complications.

The group is pushing to move beyond studies in academic settings and begin studies of the devices outside of the hospital setting.

"It's great that we can do this in academic centers, and we're learning a ton, but we need to get these projects to reach people with diabetes," he said.

"We need to see these products commercialized. That is the big challenge, and that is why we are working with the FDA."

FDA WANTS APPROVAL, TOO

Charles "Chip" Zimliki, chairman of the U.S. Food and Drug Administration's Artificial Pancreas Critical Path Initiative, which was created in 2006 to accelerate the availability of an artificial pancreas system, says he is eager to have a system approved.

"The FDA wants the artificial pancreas on the market as much as anyone else does. We just have to operate within U.S. laws to make sure it is safe and effective," Zimliki said.

Last week, the agency released guidance for how to develop a low glucose suspend system, an automatic shut-off mechanism used with an insulin pump. Medtronic already sells pumps with this the feature in Europe. It safeguards against a dangerous drop in glucose levels by temporarily halting glucose delivery.

By year-end, FDA plans to release detailed guidance on more complicated closed-loop systems, Zimliki said.

"We think of this system, the artificial pancreas, as one unit. There is going to have to be agreement among various companies to determine who is the reporting party for submitting it," he said.

"That is a relatively new idea with respect to these systems."

Zimliki, who is a type 1 diabetic, thinks the first approved devices will be ones that deliver insulin only, but he is very encouraged by the system being developed by the team at Boston University and Massachusetts General.

"They have what I call the Cadillac of closed-loop systems," he said. In addition to delivering insulin, the device also delivers an infusion of glucagon, a hormone released by the pancreas to raise blood sugar levels.

"They are showing some very promising results," he said.

(Reporting by Julie Steenhuysen, editing by Matthew Lewis)

Copyright © 2011 Reuters

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FACTBOX - Gay marriage in the United States

Posted: 24 Jun 2011 08:45 PM PDT

REUTERS - New York became the sixth U.S. state to allow gay marriage on Friday. The state-by-state battle over gay marriage has become a contentious U.S. social issue ahead of the 2012 presidential and congressional elections.

Following is a look at laws on gay marriage in the United States:

A lesbian couple celebrates inside of Stonewall Inn after the New York Senate passed a bill legalizing gay marriage in New York June 24, 2011. (REUTERS/Lucas Jackson)

Six of the 50 U.S. states and the District of Columbia now allow same-sex marriage: Iowa, Connecticut, Massachusetts, New Hampshire, Vermont and New York, the third most populous state in the country.

Four states Delaware, Hawaii, Illinois and New Jersey have approved gay civil unions. But gay marriage is specifically banned in 39 states.

In California a judge last year overturned a ban on gay marriage, but no weddings can take place while the decision is being appealed. It could set national policy if the case reaches the U.S. Supreme Court.

Four states -- New Jersey, New Mexico, New York and Rhode Island -- do not explicitly prohibit gay marriage but have not endorsed it, according to DOMA Watch, an advocacy group that supports limiting marriage to men and women.

Courts and state legislatures have legalized gay marriage in the United States but popular votes have consistently opposed same-sex unions, most recently in Maine.

Arizona is the only state where voters rejected a constitutional ban on gay marriage, in 2006, but they approved a similar measure in 2008.

California's top state court in 2008 ruled that a ban on same-sex marriage violated the state constitution. But a few months later, voters amended California's constitution, defining marriage as between a man and a woman.

The first legal same-sex marriages in the United States took place in Massachusetts in 2004.

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New York state lawmakers approve gay marriage

Posted: 24 Jun 2011 08:45 PM PDT

ALBANY, N.Y. (Reuters) - New York's state legislature gave final approval on Friday to same-sex marriages, a key victory for gay rights ahead of the 2012 presidential and congressional elections.

A gay couple kisses next to their wedding cake during a symbolic group wedding on Valentine's Day in Lima February 14, 2011.(REUTERS/Enrique Castro-Mendivil/Files)

New York will become the sixth and most populous U.S. state to allow gay marriage.

State senators voted 33-29 to approve marriage equality legislation introduced by Governor Andrew Cuomo, a Democrat in his first year of office.

"I cannot deny a person, a human being ... the same rights that I have with my wife," said Republican Senator Mark Grisanti before voting in favor of the bill.

Cheers erupted in the public gallery of the Senate after passage of the bill, which was approved earlier in the state Assembly.

After Cuomo signs the bill into law, same-sex weddings can start taking place in New York in 30 days, though religious institutions and nonprofit groups with religious affiliations will not be compelled to officiate at such ceremonies.

The New York State Catholic Conference, which represents New York state Bishops, criticized the legislation, saying that marriage is a lifelong union between one man and one woman.

"Government does not have the authority to change this most basic of truths," the bishops said in a statement.

ELECTION ISSUE

President Barack Obama, who attended a fundraiser in New York on Thursday for Gay Pride Week, has a nuanced stance on gay issues. Experts say he could risk alienating large portions of the electorate if he came out strongly in favor of such matters as gay marriage before the 2012 elections.

During the 2008 election Obama picked up important support from Evangelicals, Catholics, Latinos and African-Americans, some of whom oppose gay marriage, which has become a contentious social issue being fought state-by-state.

In California a judge last year overturned a ban on gay marriage, but no weddings can take place while the decision is being appealed. It could set national policy if the case reaches the U.S. Supreme Court.

Connecticut, Iowa, Massachusetts, New Hampshire, Vermont and the District of Columbia allow same-sex marriage, and Delaware, Hawaii, Illinois and New Jersey approved civil unions. The first legal same-sex marriages in the United States took place in Massachusetts in 2004.

But gay marriage is banned in 39 states.

(Writing by Michelle Nichols, editing by editing by Anthony Boadle)

Copyright © 2011 Reuters

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Kredit: www.thestar.com.my

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