MiniMed™ 780G Advanced Hybrid Closed Loop System Designed to Further Simplify Type 1 Diabetes Management Receives CE Mark

Friday, September 18, 2020

Medtronic plc 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 lives 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 the 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.

The MiniMed 780G system is part of the new Medtronic portfolio of insulin pumps with smartphone connectivity via 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.


References

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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