Medtronic, Inc. MDT today announced
that the first patients have been enrolled in an investigational device
exemption (IDE) study of its breakthrough Predictive Low Glucose Management
(PLGM) technology, marking a critical step toward development of an artificial
pancreas in the U.S. market. The trial will evaluate the safety of its
next-generation integrated insulin pump and continuous glucose monitoring
(CGM) system, which automatically stops insulin delivery when the sensor
measures a glucose level predicted to approach the lowest tolerable limit, and
then resumes insulin delivery after those glucose levels recover. The
technology is designed to help people with diabetes better manage the
challenges of hypoglycemia (low blood sugar) and rebound hyperglycemia (high
blood sugar) inherent in external insulin therapy use.
"Safely managing hypoglycemia without causing a rebound hyperglycemic episode
is a key challenge in managing diabetes," said Ronald Brazg, M.D., FACE
clinical assistant professor of medicine, Division of Metabolism and
Endocrinology at the University of Washington, and director of Rainier
Clinical Research Center, which is one of the participating centers for this
trial. "This important study leads the industry-wide effort to close the
diabetes treatment loop with tools that help achieve better glycemic control."
A total of up to 84 subjects will be enrolled at up to eight investigational
centers across the United States. The Medtronic system being studied includes
a fourth generation sensor with new intelligent sensor diagnostics, which is
80% smaller than the Enlite sensor currently available in the U.S. market, and
a new MiniMed insulin pump design. The objective of the study is to evaluate
the safety of the PLGM algorithm with the new sensor as well as the
algorithm's ability to prevent hypoglycemia. Hypoglycemia is a common
occurrence and concern in diabetes management and can result in confusion,
unresponsiveness and - in severe cases - even death.
PLGM technology builds upon Medtronic's already available Threshold Suspend
feature, the only technology available in the U.S. that can automatically stop
insulin delivery when sensor glucose values reach a preset level and when the
patient doesn't respond to the Threshold Suspend alarm. PLGM takes the
interaction with the insulin pump a step further by automatically stopping
insulin delivery when the sensor glucose level is predicted to approach a low
limit, and then resuming insulin delivery after those glucose levels recover.
"This study marks yet another important milestone toward the goal of an
artificial pancreas. As we continue to lead the world with advances in insulin
delivery, sensor technology and algorithms, we will be more able to help
people with diabetes enjoy greater freedom and experience better health," said
Alejandro Galindo, vice president and general manager of the Intensive Insulin
Management business at Medtronic.
The IDE study on PLGM technology demonstrates the next step toward Medtronic's
ultimate goal of developing an automated artificial pancreas - a system that
would automatically adjust insulin levels based on sensor glucose levels with
very little interaction from the patient. Previous milestones include:
* 2006: Medtronic introduced the world's first integrated insulin pump and
continuous glucose monitor.
* 2009: Medtronic introduced the world's first integrated insulin pump with
Low Glucose Suspend technology in Europe
* 2013: Medtronic introduced the MiniMed 530G with Enlite, which features
Threshold Suspend technology, in the U.S.
For more details, including enrollment information, please visit
clinicaltrials.gov ( www.clinicaltrials.gov/ct2/results?term=NCT02130284)
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