|Medtronic Initiates Pivotal Trial for Bluetooth Enabled MiniMed(TM) 780G Advanced Hybrid Closed Loop System Designed to Automate Correction Bolusing|
DUBLIN - June 8, 2019 - Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the enrollment of the first study participants in the company's pivotal trial of its Bluetooth® enabled MiniMed(TM) 780G advanced hybrid closed loop (AHCL) system. This next-generation system is designed to automate the delivery of correction boluses when the user experiences, or is predicted to experience, prolonged high glucose levels based on their sensor readings. The trial will evaluate the safety of the MiniMed 780G system in participants with type 1 diabetes at home, at work, during exercise and other daily activities. The study will enroll up to 350 adult and pediatric participants.
"We are excited to begin enrollment in this trial as we continue to advance our phased approach towards the development of a fully closed loop system. The MiniMed 780G system is designed to take our MiniMed 670G system with automated basal insulin delivery one step further so that people living with type 1 diabetes can enjoy greater freedom and less burden from their daily diabetes management," said Robert Vigersky, M.D., chief medical officer for the Diabetes Group at Medtronic. "Forgetting a pre-meal bolus can lead to hyperglycemia and we recognize that as much as people try to remember to take a pre-meal bolus or to accurately calculate their carbohydrates, real life sometimes gets in the way. As we evaluate this next-generation system, our goal is to increase automation through smart algorithms that reduce the need for patient interaction and decision-making."
Data from the feasibility study demonstrated the safety of the system and its potential to improve overall glycemic control and simplify diabetes management for individuals who forget to administer a bolus of insulin at mealtime, carb count inaccurately or choose to forgo announcing meals. Additionally, hypoglycemia (time spent below 70mg/dL) dropped by 27% and hyperglycemia (time spent above 180 mg/dL) was reduced by 14% with no serious adverse events reported.
"The early results are positive and I look forward to evaluating the system in more patients as part of the pivotal trial as the technology holds significant promise for the diabetes community," said Dr. Robert Slover, director of pediatrics at the Barbara Davis Center for Diabetes and co-principal investigator of the study. "Managing diabetes on a daily basis is a tremendous burden and responsibility so I'm very pleased to see advancements being made in the space that will enable technology to safely automate more of these decisions on behalf of patients so they can think less about their disease."
When evaluating user feedback to the system, 100% of participants in an Australia-based feasibility study led by Dr. David O'Neal rated the MiniMed 780G system as the best therapy they have ever used, and reported their overall satisfaction as extremely satisfied or very satisfied. Across both feasibility studies, high satisfaction was tied to overall improvement in Time in Range, reduced high glucose levels after meals, increased time in Auto Mode, and reduced daily effort required to manage diabetes, as the number of Auto Mode exits, alerts and fingerstick requests were all significantly reduced. All participants stated that they trusted the system to take care of their glucose and that it significantly increased their flexibility and confidence in taking care of their diabetes.
These data were shared during poster and E-poster Theater presentations at the 79th Scientific Sessions of the American Diabetes Association, in San Francisco, June 7-11, 2019:
For more details, including enrollment information for the clinical trial, please visit https://clinicaltrials.gov/ct2/show/NCT03959423
Analyst and Investor Briefing
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.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Medtronic is under license.