Home FDA MiniMed 770G Insulin Pump System with Smartphone Connectivity Receives FDA Approval

MiniMed 770G Insulin Pump System with Smartphone Connectivity Receives FDA Approval


September 1, 2020

MiniMed 770G hybrid closed loop system has received U.S. Food and Drug Administration (FDA) approval. The news was announced today by Medtronic. This newest insulin pump system offers the company’s most advanced SmartGuard™ technology, as featured in the MiniMed™ 670G system, with the added benefits of smartphone connectivity and an expanded age indication to children as young as 2.

MiniMed 770G hybrid closed loop system expands the benefits of hybrid closed loop therapy to younger children living with type 1 diabetes and makes it easier to access and share real-time CGM and pump data.

The system will enable caregivers and care partners to see user data remotely on their smartphones, with proactive in-app notices sent when sugar levels are out of range. The data can also be shared automatically with clinicians and educators to help facilitate more effective telehealth visits and product training. This connectivity also gives Medtronic the ability to provide upgrades to future technology via software updates which can further enhance security and device features.

“We’re thrilled to be launching this new system as we understand how important these data-sharing features are, particularly right now — with many individuals and families opting to see their doctors virtually via telehealth visits,” said Sean Salmon, executive vice president and president of the Diabetes Group at Medtronic. “As a parent, I understand very personally why connectivity is so important and I’m pleased we’ll be able to broaden access to hybrid closed-loop therapy with the additional peace of mind caregivers need to ensure the well-being of their loved ones. This latest launch underscores my personal commitment to making life easier for people living with diabetes through the technologies we deliver.”

The growing body of clinical evidence on hybrid closed loop therapy demonstrates both the safety of the technology and improved clinical outcomes across adults, adolescents, and younger children. A clinical study of the MiniMed 670G system conducted in children two to six years of age showed an improvement in outcomes comparable to those observed in older adolescents and adults and supported the submission of the MiniMed 770G system. In the study, A1C and Time in Range from 151 children were assessed alongside outcomes from 124 adolescents and adults over two weeks in Manual Mode and three months in SmartGuard Auto Mode (hybrid closed loop algorithm)1.

There were no episodes of severe hypoglycemia or diabetic ketoacidosis, and no serious device-related adverse events while in SmartGuard Auto Mode.

1 Salehi P, Roberts AJ, Kim GJ. Efficacy and Safety of Real-Life Usage of MiniMed 670G Automode in Children with Type 1 Diabetes Less than 7 Years Old. Diabetes Technol Ther. 2019;21(8):448-451. doi:10.1089/dia.2019.0123
2 Dr. McVean is a Medtronic patient and paid consultant
3 Refers to SmartGuard Auto Mode. Some user interaction required. Individual results may vary.
4 The Guardian Sensor (3) is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick 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).

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