Shaheen backs artificial pancreas

WASHINGTON – New Hampshire residents living with Type 1 diabetes may benefit soon from an artificial pancreas – a technological breakthrough that would monitor and control blood glucose levels.

Sens. Jeanne Shaheen, D-N.H., and Susan Collins, R-Maine, are seeking guidance from the Food and Drug Administration that would push the device to a round of large outpatient clinical studies and eventual review.

“We need to see the development of the artificial pancreas move forward,” Shaheen told reporters at a recent press conference.

“We need to see that clear guidance, so that all of those working in this field – all of the researchers, all of the doctors, all of the families who are waiting – know what’s going to happen.”

Shaheen and Collins, who co-chair the Senate Diabetes Caucus, used the press conference to urge the FDA to stick to its promise of issuing, within the next 30 days, the draft guidance that would shape outpatient study trials of artificial pancreas systems.

Karen Riley, an FDA spokeswoman who attended the press conference, said her agency is committed to achieving a safe and effective artificial pancreas, noting the head of the FDA’s artificial pancreas group suffers from Type 1 diabetes.

Type 1 diabetes is a chronic form of the disease usually diagnosed in children and young adults.

“We have said that we plan to have the guidance document for the next-generation artificial pancreas out by December 1, and we’re still saying that,” Riley said.

Riley emphasized, however, that the December deadline doesn’t call for the product to be placed on the market by that date, but only for the issuance of the guidance document so clinical studies may begin to test the safety and effectiveness of the artificial pancreas.

Researchers predict the device will be available commercially in the United States within the next five years.

Shaheen, whose granddaughter Elle suffers from Type 1 diabetes, acknowledged her stake in the campaign to win FDA approval for the artificial pancreas.

“I get to see the impact, not just on Ellie, but on her family,” Shaheen said. “I hear the stories from my daughter, who tells me some nights she’ll wake up at 3 in the morning and for some reason will feel like she has to go in and test Ellie one more time in the middle of the night.”

By combining existing technologies, such as a continuous glucose monitor and an insulin pump, with sophisticated computer software, the artificial pancreas would automatically provide the correct amount of insulin at the right time.

This automatic regulatory function of the artificial pancreas, which would be worn externally, seeks to change the current practice of constant monitoring to which Type 1 diabetes patients are subject.

“Most of the elements are all on the market already,” Riley said of the artificial pancreas.

“But it’s like any kind of technology: Getting them all together is not” on the market.

With different models of semi- and fully automated devices being developed, the artificial pancreas represents the biggest technological breakthrough in diabetes research and treatment since the discovery of insulin nearly 90 years ago.

Edward Damiano, an associate professor of biomedical engineering at Boston University who is developing a fully automated artificial pancreas, said the current system of blood sugar monitoring for Type 1 diabetes patients is impractical and presents many risks.

“It’s risky going to sleep if you have Type 1 diabetes,” he said, adding that most diabetes-induced comas occur at night when patients forget to monitor blood sugar.

Damiano’s artificial pancreas model, which is undergoing a small pediatric study at Massachusetts General Hospital in Boston, continuously controls and monitors patient blood sugar levels with a sensor, infusing insulin and another regulatory hormone under the skin when needed.

This fully automated system, he said, would severely reduce the risks faced by patients with Type 1 diabetes.

Helping to fund Damiano’s research, the Juvenile Diabetes Research Foundation launched the artificial pancreas project in 2005. Since beginning this initiative, the JDRF has sponsored artificial pancreas research throughout the country.

In addition to sponsoring research, the JDRF has worked with the Senate Diabetes Caucus to push the FDA to issue guidance, spending more than $180,000 in lobbying efforts regarding the artificial pancreas in the first nine months of 2011 alone.

“The FDA can’t be experts of everything,” said Aaron Kowalski, who oversees research for the JRDF artificial pancreas project. “It’s important that we have a voice.”

Although Damiano said a delay in the FDA’s issuance of a guidance document for the artificial pancreas hardly will affect his research, Kowalski said a delay could affect how long it takes to commercialize the device.

Damiano and Kowalski agreed, however, that even if the FDA guidance is issued in December, artificial pancreas devices wouldn’t be on the market for at least a few more years.