WASHINGTON, Nov. 10, 2010 /PRNewswire-USNewswire/ — Diabetes
experts at a meeting convened by the U.S. Food and Drug
Administration (FDA) and the National Institutes of Health (NIH)
took the next step in advancing efforts toward the development of
an artificial pancreas: putting forth clinical recommendations to
ensure the safe and effective testing of artificial pancreas
technology in real-life situations. We are pleased at today’s
meeting there was a strong consensus among leading clinicians,
researchers and industry leaders regarding the path toward
outpatient studies for both low-glucose suspend and artificial
pancreas systems.
Even with treatments available today, tight blood sugar control
remains a challenge and daily struggle for those living with type 1
diabetes. In fact, the majority of people living with the disease
are not achieving recommended target levels. “An artificial
pancreas, essentially a device that would both measure blood sugar
and dispense appropriate amounts of insulin to keep levels in
optimal range, would take much of the guesswork out of daily
management of the disease,” said Dr. Aaron Kowalski, Assistant Vice
President of Treatment Therapies at JDRF. “In the long-run,
controlled blood sugar levels will help to lessen or avert the
devastating complications from type 1 diabetes.”
To date, artificial pancreas devices have been successfully
tested in controlled inpatient or hospital settings, demonstrating
the potential for this technology to improve blood sugar control.
Now it must be tested safely in real-world conditions. And clear
and reasonable regulatory guidelines must be established to ensure
that the upcoming studies advance the technology to reach patients
as soon as possible.
“We believe a safe and effective first generation artificial
pancreas system is possible with today’s technology, even as we
continue to encourage development of improved devices. Experts at
today’s FDA workshop outlined a clear path
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