Medtronic Announces Commencement of Pivotal Study of First Predictive Low Glucose Mgmt Technology for People with Diabetes

Medtronic, Inc. (NYSE: MDT) today announcedthat the first patients have been enrolled in an investigational deviceexemption (IDE) study of its breakthrough Predictive Low Glucose Management(PLGM) technology, marking a critical step toward development of an artificialpancreas in the U.S. market. The trial will evaluate the safety of itsnext-generation integrated insulin pump and continuous glucose monitoring(CGM) system, which automatically stops insulin delivery when the sensormeasures a glucose level predicted to approach the lowest tolerable limit, andthen resumes insulin delivery after those glucose levels recover. Thetechnology is designed to help people with diabetes better manage thechallenges of hypoglycemia (low blood sugar) and rebound hyperglycemia (highblood sugar) inherent in external insulin therapy use."Safely managing hypoglycemia without causing a rebound hyperglycemic episodeis a key challenge in managing diabetes," said Ronald Brazg, M.D., FACEclinical assistant professor of medicine, Division of Metabolism andEndocrinology at the University of Washington, and director of RainierClinical Research Center, which is one of the participating centers for thistrial. "This important study leads the industry-wide effort to close thediabetes treatment loop with tools that help achieve better glycemic control."A total of up to 84 subjects will be enrolled at up to eight investigationalcenters across the United States. The Medtronic system being studied includesa fourth generation sensor with new intelligent sensor diagnostics, which is80% smaller than the Enlite sensor currently available in the U.S. market, anda new MiniMed insulin pump design. The objective of the study is to evaluatethe safety of the PLGM algorithm with the new sensor as well as thealgorithm's ability to prevent hypoglycemia. Hypoglycemia is a commonoccurrence 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 Suspendfeature, the only technology available in the U.S. that can automatically stopinsulin delivery when sensor glucose values reach a preset level and when thepatient doesn't respond to the Threshold Suspend alarm. PLGM takes theinteraction with the insulin pump a step further by automatically stoppinginsulin delivery when the sensor glucose level is predicted to approach a lowlimit, and then resuming insulin delivery after those glucose levels recover."This study marks yet another important milestone toward the goal of anartificial pancreas. As we continue to lead the world with advances in insulindelivery, sensor technology and algorithms, we will be more able to helppeople with diabetes enjoy greater freedom and experience better health," saidAlejandro Galindo, vice president and general manager of the Intensive InsulinManagement business at Medtronic.The IDE study on PLGM technology demonstrates the next step toward Medtronic'sultimate goal of developing an automated artificial pancreas - a system thatwould automatically adjust insulin levels based on sensor glucose levels withvery 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 visitclinicaltrials.gov ( www.clinicaltrials.gov/ct2/results?term=NCT02130284)