|Medtronic Accelerates Path to Artificial Pancreas with New MiniMed 640G Data and Start of Hybrid Closed Loop Trial|
MiniMed 640G System Shown to Further Reduce Hypoglycemia; Pivotal Study to Examine Safety of Hybrid Closed Loop System for People with Diabetes
BOSTON - June 6, 2015 - As part of its commitment to developing an artificial pancreas for people with diabetes, Medtronic plc (NYSE:MDT) today announced results from the European User Evaluation of the MiniMed® 640G system, which demonstrated that the pump's exclusive SmartGuard technology can reduce hypoglycemia (low blood glucose) and offer further advancement in automation compared to previous generation Medtronic insulin pump systems. The results will be presented in a poster session at the American Diabetes Association 75th Scientific Sessions on Sunday, June 7 at 12:00pm in Hall B at the Boston Convention and Exhibition Center. Medtronic also announced that patient enrollment has begun in the first ever pivotal study of a Hybrid Closed Loop system, which is designed to automatically control glucose levels 24 hours a day with less input from patients.
MiniMed 640G User Evaluation Study
"Severe hypoglycemia can have devastating effects on people with diabetes and even milder episodes can really impair quality of life," said Pratik Choudhary, M.D., senior lecturer and consultant in diabetes at King's College London and one of the lead investigators in the European User Evaluation. "The more we can do to minimize the impact of hypoglycemia, the better we can make lives of people with diabetes. That is why patients in our user evaluation really loved MiniMed 640G with SmartGuard technology, because it effectively and unobtrusively reduced hypoglycemia."
The MiniMed 640G system includes a new insulin pump design to provide convenient diabetes management with a simple user interface, full-color screen, waterproofing1 and remote bolus. The product is approved for investigational use only in the U.S., where a large, multi-center pivotal trial is currently underway.
Hybrid Closed Loop Pivotal Study
"Insulin pumps and continuous glucose monitoring systems have greatly improved the ability for people with diabetes to achieve better glucose control and live longer, healthier lives," said Satish Garg, M.D., professor of pediatrics and medicine and director of the adult diabetes program at the University of Colorado Barbara Davis Center for Childhood Diabetes. "However, even with these systems, patients must make hundreds of decisions each day. Simplifying this self-management with a more automated Hybrid Closed Loop system would have a very meaningful impact on these patients' lives."
This is the first pivotal trial of closed loop technology conducted in the U.S. As Medtronic's largest and longest at-home closed loop study, this single-arm, multi-center, home and hotel clinical study will enroll up to 150 patients aged 14-75 with type 1 diabetes on insulin pump therapy. Medtronic's new insulin pump platform and fourth-generation sensor will be used in this trial. Additional trial details, including enrollment information, can be found at ClinicalTrials.gov (Identifier: NCT02463097)
"After years of research and development, the critical components of a closed loop system are here," said Francine Kaufman, M.D., chief medical officer and vice president, global medical, clinical & health affairs at Medtronic Diabetes. "We are thrilled to be partnering with the world's leading investigators to do the clinical work to bring this technology to market so that it can help people with diabetes enjoy even greater freedom and better health."
Additional Posters Presented at ADA on Medtronic Advancements Toward an Artificial Pancreas:
About the Diabetes Group at Medtronic (www.medtronicdiabetes.com)
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1 MiniMed 640G is waterproof in up to 12 feet of water for up to 24 hours. See IFU for care instructions to help maintain waterproof.