THURSDAY, Dec. 1 (HealthDay News) -- The U.S. Food and Drug
Administration on Thursday issued new guidelines aimed at helping
speed up the development of artificial pancreas systems.
If they become a reality, such technologies could make a huge
difference for people with type 1 diabetes, who need insulin
injections to control their blood sugar and survive.
Artificial pancreas systems combine current technologies for
continuous blood sugar monitoring and pumps to deliver insulin as
needed. These systems are designed to keep patients' insulin levels
within normal ranges, by reacting to changes in blood sugar.
So far, however, equipment problems, computer glitches and
problems with the insulin used have hampered development of these
systems, the FDA said in a news release.
"We really are trying to get these devices to the market as quickly as possible," Charles Zimliki, leader of the FDA's Artificial Pancreas Working Groups and Critical Path Initiative, said during a news conference Thursday.
That's why the agency has taken the unusual step of developing a
guidance for approval, something which is usually done after a
device had been developed and tested, he said.
Zimliki said he has no idea when an approved device might be
available. To date, the FDA has approved more than 20 clinical
studies for artificial pancreas systems.
The FDA's new guidelines make designing, testing and safety and
effectiveness requirements more flexible. For example, they propose
more flexibility in the choice of clinical trial outcomes, number
of patients needed and the length of the trial.
"We really wanted to make a push; we felt like it was a good idea to give academicians and people that aren't familiar with the regulatory process a pathway to develop these systems," Zimliki said. "We want people to move these things forward; we think this guidance will allow people to get a safe and effective product on the market quickly."
In type 1 diabetes, the pancreas produces little or no insulin,
an essential hormone necessary for controlling blood sugar. People
with type 1 diabetes have to monitor their blood sugar throughout
the day, and calculate how much insulin they need to lower their
blood sugar, which is delivered using a syringe or insulin
An artificial pancreas system combines an insulin pump and a
continuous glucose monitor with a sensor placed under the patient's
skin. The pump and monitor work together, tracking blood sugar and
automatically pumping measured doses of insulin as determined by a
These systems help eliminate, or reduce the severity of
dangerous drops in blood sugar by stopping insulin administration
when blood sugar levels near a predetermined threshold.
The device is not a cure, but it might reduce dangerous high and
low blood sugar levels, giving patients a better quality of life
and reducing the risk of diabetes-related complications, the FDA
The new guidelines recommend a three-phase clinical study
progression "so that studies may move to an outpatient setting as
quickly as possible." The agency is also suggesting other ways to
streamline the testing process, including ways to use existing
safety and effectiveness data for the components that make up the
system, and allowing data from clinical studies done outside of the
United States to be used in the approval process.
In addition, those conducting the clinical trials have the
option of demonstrating that the system controls blood sugar as
well as standard therapies, or showing that it gives better blood
sugar control when compared to other therapies.
"When final, the guidance will help manufacturers and investigators assemble submissions for clinical trials as well as product-approval submissions," the FDA said.
In June, the FDA released a draft guidance on safety and
effectiveness goals for researchers and industry in developing the
Low Glucose Suspend System, a first-generation artificial pancreas
system. Those results helped inform this new guidance, Zimliki
Hurdles in developing these systems include making sure the
implanted sensors remain clear, the need to periodically
recalibrate blood sugar monitors, problems with the software needed
to operate insulin infusion pumps, problems creating algorithms to
deliver insulin that take into account how long it takes the body
to absorb it, the need for a faster-acting insulin and the overall
development of safer and more reliable algorithms.
Another issue is the lack of a glucagon formulation that can be
used in infusion pumps. Glucagon is a hormone used to treat severe
low blood sugar. "There is a need for a glucagon formulation that
is stable over several days and can be delivered by an infusion
pump," the FDA said.
For more on type 1 diabetes, visit the
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