Medtronic Secures CE Mark for MiniMed™ 780G Advanced Hybrid Closed Loop System Designed to Further Simplify Type 1 Diabetes Management
Medtronic (NYSE:MDT) has received CE Marking for its MiniMed™ 780G insulin pump, designed for type 1 diabetes patients aged 7 to 80. This system automates insulin delivery via the SmartGuard™ algorithm, providing basal insulin and correction boluses every five minutes. It allows customizable glucose targets and features Bluetooth connectivity for real-time glucose monitoring. Clinical feedback highlights improved diabetes management and quality of life. The MiniMed 780G is set to ship in select European markets this fall but is still under investigation in the U.S.
- CE Marking obtained for MiniMed™ 780G, enabling commercialization in Europe.
- Advanced SmartGuard™ algorithm improves insulin delivery accuracy.
- Bluetooth connectivity facilitates real-time glucose monitoring via smartphones.
- Positive clinical feedback indicates enhanced quality of life for users.
- MiniMed 780G is not yet approved for commercial distribution in the U.S.
- Potential delays in shipping and regulatory approvals in other markets.
Next Generation Closed Loop Insulin Pump System Features
Auto-Correction Algorithm and Bluetooth Connectivity
DUBLIN, June 11, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced CE (Conformité Européenne) Marking of its MiniMed™ 780G system, a next generation closed loop insulin pump system for the treatment of type 1 diabetes in people age 7 to 80 years. Leveraging the company’s most advanced SmartGuard™ algorithm, the system automates the delivery of both basal insulin and correction boluses every five minutes to help people with diabetes avoid highs and lows with greater ease. The MiniMed 780G system enables the personalization of glucose goals with an adjustable target setting as low as 100 mg/dL (5.5 mmol/L) — lower than any other advanced hybrid closed loop system — and is designed to help stabilize blood sugar levels and further improve glucose control.
“We wanted to design a system that further simplifies diabetes management and adapts to people’s life with the goal of enhancing their experience in a seamless way,” said Sean Salmon, Executive Vice President and President of the Diabetes Group at Medtronic. “We know it can be challenging to have to calculate carbohydrate intake before every snack or meal on a daily basis to ensure the right amount of insulin is dosed. With this system, users will have an extra layer of coverage for those times they miscalculate their carbs or forget to pre-bolus with analgorithm that automatically corrects for high glucose when needed. We want to help people spend more time living their life and less time worrying about their diabetes management — we’re confident this system delivers on that important goal.”
Patients who participated in the clinical study provided feedback that the MiniMed 780G system “made life with diabetes and control so much easier” and that it made “life significantly easier.”
In addition to the automated algorithm which includes technology from DreaMed Diabetes, the MiniMed 780G system was designed to be easy to use by requiring less input from the user1. With the addition of Bluetooth® connectivity, the MiniMed 780G system will enable users and their care partners to see real-time glucose data and trends on compatible iOS and Android smartphones via apps. Additionally, healthcare providers will find that managing patients on the system is simple as there are only a few settings that need adjustment to enable optimal use of the technology.
“I am incredibly proud of the strong collaboration that resulted in this meaningful step forward with the MiniMed 780G system, which the clinical trial has demonstrated to be a beneficial tool for a wide range of patients and particularly adolescents,” said Professor Moshe Phillip, director of the Institute for Endocrinology and Diabetes, National Center of Childhood Diabetes, Schneider Children’s Medical Center of Israel, co-founder and chief science officer, DreaMed Diabetes. “By continuing to increase the automation of insulin pump systems, we can further reduce burden for people living with diabetes while simultaneously driving positive clinical outcomes.”
The system is expected to begin shipping this Fall in select countries in Europe. In the United States, the MiniMed 780G system is investigational use only and not approved for sale.
The data from three trials using the next generation advanced hybrid closed loop system from Medtronic will be presented in a symposium at the virtual 80th Scientific Sessions of the American Diabetes Association.
- Symposium: The Next Generation of Automated Insulin Delivery Systems for Persons with Type 1 Diabetes – Four New Clinical Trials
- June 12, 2:00 – 4:00 pm (CDT)
The MiniMed 780G system is part of the new Medtronic portfolio of insulin pumps with smartphone connectivityvia Bluetooth. Additional systems with CE Mark include the MiniMed™ 770G2 system which uses the same hybrid closed loop technology as the current MiniMed™ 670G system that is available in many parts of the world. There is also a MiniMed™ 720G3 system with CE Mark that provides readings from a Medtronic glucose sensor without automating any insulin delivery based off those readings. These MiniMed™ 700 series pumps will be made available in countries around the world based on local market approvals and regulations.
About the Diabetes Group at Medtronic (www.medtronicdiabetes.com)
Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
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.
Android is a trademark of Google LLC.
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.
-end-
1 When the MiniMed 780G system is not using the SmartGuard feature, pump functions are operating in manual mode. In manual mode, the sensor glucose readings from Guardian™ Sensor 3 are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick/BG meter reading may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the Guardian™ Sensor 3 in manual mode.
2 Not approved for commercial distribution in the United States.
3 Not approved for commercial distribution in the United States.
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