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Entries in Type 1 (3)

Thursday
Dec012011

FDA Outlines Plan for Artificial Pancreas Approval

Jupiterimages/Thinkstock(WASHINGTON) -- The U.S. Food and Drug Administration Thursday issued guidance for scientists and device manufacturers seeking approval for the artificial pancreas --  a portable device to help people with type 1 diabetes control their blood sugar levels.

The draft guidance offers design and testing recommendations aimed at easing the approval process while still meeting statutory requirements for safety and effectiveness. It comes less than a month after lawmakers, health professionals, advocacy organizations and patients lobbied for expedited approval of the device.

"We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.

The guidance suggests ways to leverage existing safety and effectiveness data for components that make up the device, but still recommends three phases of clinical trials.

Jeffrey Brewer, the president and CEO of the Juvenile Diabetes Research Foundation (JDRF), has a very personal reason for wanting the FDA to expedite their review of the artificial pancreas. His son has type 1 diabetes, meaning his body doesn't produce insulin. Type 1 diabetics either have to self-administer insulin or use pumps that release insulin throughout the day.

"Diabetics have to self-prescribe insulin all day long, and they can makes mistakes and occasionally kill themselves," he said. "My son almost died because he gave himself too much insulin. The insulin pump didn't have the right features to shut off insulin delivery."

According to JDRF, as many as three million Americans may have type 1 diabetes, and Brewer said the artificial pancreas can potentially save those people's lives.

Research published in April found that using the artificial pancreas was better at controlling blood sugar than an insulin pump. Low blood sugar during the night is often a problem for type 1 diabetics.

"[The system] has the potential to improve safety and efficacy of insulin delivery and may in future allow more flexible lifestyles in conjunction with improved glycemic control for people with type 1 diabetes," wrote the study authors, led by Roman Hovorka of the University of Cambridge.

One of the sticking points that could potentially delay the device's approval is the fact that continuous glucose monitors are not approved to provide insulin dosages, only to alert a person that blood sugar is high or low.

"Today's insulin systems are basing all dosing decisions on that monitor, so we need to make sure we test them appropriately," said Charles Zimliki, chair of the FDA's Artificial Pancreas Critical Path Initiative said in November.

Zimliki, a type 1 diabetic himself, said he wants the device to be approved as quickly as possibly.

"An artificial pancreas system could allow people with diabetes, especially children, to live active lives without the constant need to constantly monitor their glucose levels," he said in a statement Thursday. "While not a cure, an artificial pancreas could reduce dangerous high and low blood sugars, providing a better quality of life for those with diabetes and lowering the risk for future diabetes-related complications."

Copyright 2011 ABC News Radio

Wednesday
Jun222011

Kids Hit Capitol for Diabetes Cure

BananaStock/Thinkstock(WASHINGTON) -- Four children living with type 1 diabetes testified on Capitol Hill Wednesday to urge lawmakers to invest in research that could provide a cure for the disease that afflicts nearly three million Americans.

"I was diagnosed with juvenile diabetes at age six. I had been losing weight, wetting the bed at night and had extreme thirst. I was always tired and very emotional," Jonathan Platt, an eight-year-old from Tarzana, Calif., said in prepared remarks. "I was thinking, How did I get this disease? I didn't know what it was. I was very scared and nervous.

"I am here to ask you to continue to do your part and fund research to find a cure," he contintued. "A cure for diabetes means that I could go to any summer camp and have sleepovers whenever and wherever I want. It means I could be a regular kid again. Most of all, it would mean I would not have diabetes."

The Juvenile Diabetes Research Foundation estimates that of the three million Americans who have type 1 diabetes -- in which the body does not produce insulin -- 15,000 children are diagnosed each year. This week close to 150 children gathered in Washington to participate in the foundation's children's congress, where children could interact with lawmakers and explain the importance of diabetes research.

In a rare glimpse at the childhood of a Supreme Court justice, Sonia Sotomayor shared her own story of living with diabetes with the group of delegates Tuesday.

"I was ashamed," Sotomayor said as she described how she learned she had type 1 diabetes at the age of seven. Before she was diagnosed, Sotomayor had chronic thirst and wet the bed at night.

"It's a disease you have to deal with, but you can," Sotomayor told the group of children.

The Supreme Court justice continues to cope with diabetes, injecting herself with insulin four to six times a day.

One child asked Sotomayor if living with type 1 diabetes ever gets easier, to which Sotomayor replied, "Absolutely." She said having type 1 diabetes taught her discipline, which has helped her as a student and to land the job of her dreams as a Supreme Court justice.

"Figuring out how I felt all the time," she said. "All of that taught me discipline."

Copyright 2011 ABC News Radio

Friday
Feb042011

Researchers Link Type 1 Diabetes in Children to Common Cold

Photo Courtesy - Getty Images(SYDNEY, Australia) -- Researchers say the common cold could be linked to type 1 diabetes in at risk children. 

This research can explain the dramatic rise in diabetes cases among very young children, researchers suggest, and could lead to improved treatment and prevention.

The analysis of the 26 studies published in BMJ Online First showed that young type 1 diabetic patients are 10 times more likely to exhibit symptoms of enterovirus infection than children without the disease.

Researcher Maria Craig, PhD, of the University of South Wales in Sydney, Australia told WebMD, "We saw a very strong association between enterovirus infection and type 1 diabetes."

"Obviously studies like the ones we looked at cannot prove cause and effect, but the findings make a strong case for this association," she added.

Copyright 2011 ABC News Radio







ABC News Radio