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March 05. 2012 8:24PM

Medical device trial gives NH diabetics hope


ELLE SHAHEEN 

For three carefree days in January, the 12-year-old granddaughter of New Hampshire Sen. Jeanne Shaheen ate like a normal tween, savoring high-carb food without worrying about disastrous consequences.

Elle Shaheen, who suffers from Type 1 diabetes, indulged her carbo cravings while participating in a medical trial for an artificial pancreas. The device is designed to both monitor the levels of glucose in her blood and adjust insulin levels accordingly.

Elle took part in the trial at Massachusetts General Hospital, said Aaron Kowalski, assistant vice president for treatment therapies research at the Juvenile Diabetes Research Foundation. The organization is sponsoring trials of the device.

“She ate Spaghetti-Os, grilled cheese sandwiches, French fries, ice cream, things that when we eat them there's a lot of complexity,” said Elle's mother, Stefany Shaheen.

Normally, Elle has to prick her finger about a dozen times a day to test the glucose levels in her blood. She then adjusts her insulin.

All sorts of things — from her latest meal to a sprint in the school yard — can cause her blood sugar to fluctuate, which requires another prick and an adjustment to her insulin. She even has to be tested when she sleeps.

But the promise of the artificial pancreas means the monitoring and insulin adjustment would be controlled by computer. All would be done on a pancreatic sort of auto-pilot.

“That may sound easy, but it's not very easy. There's a tremendous amount of work, and if you don't do it well, bad things can happen,” Kowalski said.

The trials will take several stages. During Elle's January trial, she was confined to the hospital, and the device was attached to an IV pole.

In the future, her mother hopes she would qualify for a trial with a much more portable device, about the size of an iPhone. Eventually, there could be an in-home trial.

“Part of the benefit of her participation is she sees how important the research is and how important it is for the science to get it right,” her mother said.

If she's interested in future trials, Elle will have to apply for each one.

Kowalski stressed that no influence, even that of a sitting U.S. senator, would get a patient into a trial. They are strictly controlled by the FDA and review boards of participating institutions.

“I'm quite certain strings aren't being pulled here,” Kowalski said.

He did say that regulatory barriers for such a device are significant. As a leader of the congressional diabetes causcus, Sen. Shaheen helps organizations such as his to work through them.

He said the Medtronic Veo, a device that monitors for extreme highs and lows of blood sugar and will halt insulin dosage, is available in every country except the United States. It is in its final trials in the United States, and Sen. Shaheen is trying to accelerate the process, Kowalski said.


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