More progress made on artificial pancreas for diabetes patients - Frosted Plastic Film Manufacturer

"The FDA has really turned the corner and is movingmuch faster.... My hope is that in the next year or two, we'll seeapprovals on devices that can minimize [low blood sugar levels],and that's just the tip of the iceberg." Type 1 diabetes is an autoimmune disease in which the body's immunesystem turns against healthy cells. In type 1 diabetes, the immunesystem attacks beta cells in the pancreas, effectively destroyingthe body's ability to produce the hormone insulin. Insulin helpsmetabolize carbohydrates from food and fuels the body's cells. Type 1 diabetes can be managed with insulin injections or a pumpthat delivers insulin via a tiny catheter inserted under the skinevery few days.

The problem with both insulin-delivery techniquesis that people have to estimate how much insulin they'll need basedon the foods they eat and how much activity they will be doing. Too much insulin can result in low blood sugar levels(hypoglycemia), which, in turn, can cause a person to pass out. Lowblood sugar levels can even lead to death. Too little insulin leadsto high blood sugar levels (hyperglycemia), which over time cancause serious complications, such as heart disease and kidney andeye problems. An artificial pancreas, which sometimes is referred to as aclosed-loop system because it doesn't require user input, couldpotentially solve those problems by taking over the decision-makingprocess and applying sophisticated computer algorithms to decidehow much insulin is needed at any given moment.

But developing such a device isn't as easy as it sounds. First, the device has to be able to continuously detect patients'blood sugar levels and know whether the levels are trending up ordown. There has to be a piece of the device that holds and deliversinsulin. And there needs to be a way to deal with low blood sugarlevels.

Someone with type 1 diabetes typically consumes food or asugar-containing drink to counteract drops in blood sugar. Somedevices will shut off and sound an alarm to alert the person totreat their low blood sugar. At least one device in development contains not only insulin, butalso a hormone called glucagon that can quickly raise blood sugarlevels. Researchers at Boston University, Harvard Medical School andMassachusetts General Hospital are developing the device.

Inaddition to reporting on the latest in-hospital trials of theirdevice, they presented a prototype that uses a continuous glucosemonitor, an insulin pump that also will house the artificialpancreas software with a low-powered Bluetooth device, and an appdesigned for the iPhone 4S, said Edward Damiano, one of thedevice's developers. "It's a totally pocket-sized device," said Damiano, associateprofessor of biomedical engineering at Boston University. Damiano,who will be wearing his team's version of the artificial pancreasfor the presentation, said their device is the only one that trulyis closed-loop because it includes both glucagon and insulin,allowing it to respond to both high and low blood sugar levelswithout user input. Damiano said they soon will be filing paperwork for five-dayin-hospital trials of their system.

They also are planning twotransitional studies for summer 2013 that will include campers at adiabetes camp and hospital personnel with type 1 diabetes. If allgoes well, their hope is that they will be able to do a large-scalesix-month outpatient trial by 2015, Damiano said. Another research group, at the University of Virginia School ofMedicine, is recruiting people for outpatient trials on anartificial pancreas device similar to the one Damiano's team isworking on. Although this device also uses a smartphone to displaythe device's information, however, it contains only insulin, notglucagon.

Another device, called a Hypoglycemia-Hyperglycemia Minimizer,which was developed in a partnership with the Juvenile DiabetesResearch Foundation and the insulin-pump maker Animas, was able toautomatically predict increases and decreases in blood sugarlevels. It also was able to change insulin delivery accordingly ina study that included 13 people between 24 and 57 years old withtype 1 diabetes. "The successful completion of this study using the[Hypoglycemia-Hyperglycemia Minimizer] system in a human clinicaltrial is a significant step forward in the development of anadvanced first-generation artificial pancreas," Dr. Henry Anhalt,chief medical officer for Animas, said in a statement.

Kowalski is optimistic about the future development of anartificial pancreas. "This gives me a lot of hope that we're really starting to roll towhat could be full-blown product development," he said. Kowalski said he believes the artificial pancreas likely will beapproved in steps. "I don't think it will be one product, but anevolution," he said.

First, he said, will be a device designed to minimize the impact ofsevere low blood sugar. After that, it's likely that there will bea device to prevent low blood sugar from occurring in the firstplace. "Each of these steps should be meaningful, make life easier andimprove glucose control for people with type 1 diabetes," Kowalskisaid. More information Learn more about the artificial pancreas from the U.S.

Food and Drug Administration . SOURCES: Aaron Kowalski, Ph.D., assistant vice president, treatmenttherapies, Juvenile Diabetes Research Foundation; Edward Damiano,Ph.D., associate professor, biomedical engineering, BostonUniversity; June 9, 2012, presentations, American DiabetesAssociation annual meeting, Philadelphia Copyright © 2012 HealthDay . All rights reserved.

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