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Will the federal government kill the artificial pancreas? The Juvenile Diabetes Research Foundation (JDRF) is raising the alarm over FDA guidelines that could stifle the technology necessary for the development of an artificial pancreas.
At issue is Low Glucose Suspend (LGS) technology, which uses blood sugar data to temporarily switch off an insulin pump when a user's blood sugar is heading south. It's an important first step toward an artificial pancreas, and the JDRF says that devices using LGS are already being used in 40 other countries.
The JDRF accuses the FDA of imposing burdensome rules that would delay the introduction of LGS technology in the United States for years to come. It has three central issues with the proposed regulations.
First, the JDRF writes, "This guidance will require multiple clinical trials (inpatient and outpatient) involving a large number of subjects in order to show statistically significant differences in preventing hypoglycemia. This would be an excessive hurdle in order to make available to patients a simple but important feature."
The foundation recommends instead that studies focus simply on whether devices with the technology are safe. Once they were in the marketplace, data could be gathered on actual users rather than a limited number of test subjects.
Second, the FDA is unclear on whether continuous glucose monitors should be part of these studies. The JDRF points out that "the use of any other outcomes would be considered impractical by the diabetes research community." Put simply, this kind of technology really needs to be used with a CGM to have any point, and the FDA should require them as part of studies, the JDRF says.
Finally, the proposed federal guidelines would require separate studies for equivalent system components. In other words, competing LGS systems that work in the same way but have slightly different make-ups would each have to go through full clinical trials. The JDRF says this "would severely limit choice for patients and discourage the development of technologies serving a critical public health need."
The JDRF submitted its feedback to the FDA on September 20, and it urges changes to the guidelines as soon as possible.
"This proposed guidance by the FDA will only further delay access to this system in the United States," said Jeffrey Brewer, JDRF president and CEO. "We urge the FDA to resolve three core issues in the guidance to enable people with diabetes to have access to this lifesaving technology as soon as possible."
Categories: Artificial Pancreas, Clinical Trials, Continuous Glucose Monitors, Diabetes, Diabetes, FDA, JDRF, Jeffrey Brewer , Juvenile Diabetes Research Foundation, LGS Technology, Low Glucose Suspend Technology
12 comments - Dec 8, 2011
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